
Latest News on Sun Pharma
Sun Pharma receives green light for obesity treatment injection similar to Wegovy.
Sun Pharmaceutical Industries has received approval for a weight loss injection similar to Novo Nordisk’s Wegovy. The new treatment, called “SUN-144”, is a once-weekly injection that helps with weight management in adults with obesity or overweight with at least one weight-related condition. This approval marks a significant milestone for Sun Pharma, as it enters the growing market for anti-obesity treatments.
Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been highly successful in treating obesity, with sales exceeding $1 billion in 2022. SUN-144 is also a GLP-1 receptor agonist, which works by mimicking a natural hormone that helps regulate appetite and food intake. Clinical trials have shown that SUN-144 is effective in reducing body weight and improving glycemic control in patients with type 2 diabetes.
The approval of SUN-144 is expected to increase competition in the anti-obesity market, which is currently dominated by Novo Nordisk’s Wegovy and Saxenda. However, Sun Pharma’s entry into the market may also lead to increased accessibility and affordability of these treatments, which could benefit patients who struggle with obesity and related health conditions.
Sun Pharma’s SUN-144 has shown promising results in clinical trials, with significant weight loss and improvements in cardiovascular risk factors. The treatment has also been well-tolerated, with common side effects including nausea, vomiting, and diarrhea. As the global prevalence of obesity continues to rise, the demand for effective and safe treatments is increasing. Sun Pharma’s entry into the market is expected to help meet this demand and provide patients with more options for managing their weight and related health conditions.
The approval of SUN-144 is a significant achievement for Sun Pharma, which has been expanding its portfolio of specialty and generic products. The company has a strong presence in the pharmaceutical industry, with a global footprint and a wide range of products. With the launch of SUN-144, Sun Pharma is poised to become a major player in the anti-obesity market, which is expected to continue growing in the coming years. As the company prepares to launch SUN-144, it is likely to focus on educating healthcare professionals and patients about the benefits and risks of the treatment, as well as its potential to improve health outcomes for individuals with obesity and related conditions.
Several major Indian pharmaceutical companies, including Sun Pharma, Cipla, Zydus, and Graviti, have issued recalls for certain medications in the United States market.
Several major pharmaceutical companies, including Sun Pharma, Cipla, Zydus, and Graviti Pharmaceuticals, are recalling various products in the US due to manufacturing issues, according to recent US FDA enforcement reports. The recalls are primarily related to problems with impurities, quality control, and production processes.
Sun Pharma is recalling over 24,000 bottles of Fluocinolone Acetonide topical solution and Clindamycin Phosphate topical solution due to out-of-specification results for impurities and assay. Cipla is recalling more than 15,000 syringes of Lanreotide Injection, used to treat a rare hormonal condition, due to production issues at its Greek manufacturing partner, Pharmathen. The production of Lanreotide has been temporarily paused to address quality concerns, resulting in limited supply.
Additionally, Cipla is recalling over 92,000 tubes of Diclofenac Sodium Topical Gel due to failed pH specifications. Graviti Pharmaceuticals is recalling over 4,000 bottles of Furosemide Tablets due to the presence of a foreign substance. Zydus Pharmaceuticals is recalling over 22,000 bottles of Icosapent Ethyl capsules due to oxidation caused by leakage, which may lead to inconsistent therapeutic effects and increased gastrointestinal side effects.
These recalls highlight the importance of quality control and manufacturing standards in the pharmaceutical industry. The FDA’s enforcement actions aim to ensure that products meet strict safety and efficacy standards to protect public health. The recalls may result in temporary shortages of these products, and patients are advised to consult their healthcare providers for alternative treatments.
The recalls also underscore the need for pharmaceutical companies to maintain robust quality control systems and adhere to good manufacturing practices (GMPs) to prevent such issues. The companies involved are taking corrective actions to address the problems and prevent future occurrences. The FDA will continue to monitor the situation and take further action if necessary to ensure the safety and efficacy of pharmaceutical products in the US market.
Sun Pharma receives DCGI approval for generic version of Wegovy, plans March release ahead of Semaglutide patent expiration.
Sun Pharmaceutical Industries has received approval from the Drugs Controller General of India (DCGI) to launch a generic version of Novo Nordisk’s Wegovy, a medication used to treat obesity. The approval comes as the patent for the active ingredient, semaglutide, is set to expire in March 2023.
Wegovy, which contains semaglutide, is an injectable glucagon-like peptide-1 (GLP-1) receptor agonist that helps with weight loss in adults with obesity. The medication has been shown to be effective in reducing body weight and improving glycemic control in patients with type 2 diabetes.
Sun Pharma’s generic version of Wegovy will be launched in India in March, coinciding with the patent expiry of semaglutide. The company has been working on developing a generic version of the medication for some time and has completed the necessary clinical trials and regulatory requirements to obtain approval from the DCGI.
The launch of Sun Pharma’s generic Wegovy is expected to increase access to this medication for patients in India, where obesity is a growing health concern. According to the World Health Organization (WHO), India has one of the highest rates of obesity in the world, with over 30% of the population classified as obese.
The generic version of Wegovy is also expected to be more affordable than the branded version, making it more accessible to patients who may not have been able to afford the medication otherwise. Sun Pharma’s entry into the market is likely to increase competition and drive down prices, benefiting patients and healthcare systems.
Novo Nordisk’s Wegovy has been a blockbuster medication, with sales of over $1 billion in 2022. The patent expiry of semaglutide is expected to lead to a significant increase in the availability of generic versions of the medication, which could impact Novo Nordisk’s sales. However, the company has a strong pipeline of new medications and is expected to continue to be a major player in the pharmaceutical industry.
Overall, the approval of Sun Pharma’s generic Wegovy is a significant development for patients in India, who will now have access to an affordable and effective treatment option for obesity. The launch of the generic medication is also expected to increase competition in the market, driving down prices and benefiting healthcare systems.
Sun Pharma Sets Sights on $10 Billion Organon Takeover to Bolster US Presence
Sun Pharmaceutical Industries Ltd., India’s largest drug manufacturer, is considering a monumental acquisition of Organon, a US-based company specializing in women’s health and biosimilars. The potential deal, valued at $10 billion, is being led by the company’s founder, Dilip Shanghvi. If successful, this acquisition would be a significant milestone for Sun Pharma, enabling the company to expand its presence in the lucrative US market and accelerate its growth in the high-potential biosimilars sector.
The acquisition of Organon would provide Sun Pharma with a substantial boost in the US market, where the company has been seeking to increase its presence. Organon’s portfolio of women’s health products and biosimilars would complement Sun Pharma’s existing product line, enabling the company to offer a more comprehensive range of treatments to patients. Additionally, the deal would grant Sun Pharma access to Organon’s established distribution network and sales infrastructure in the US, facilitating the company’s ability to reach a broader customer base.
The biosimilars sector is a high-growth area, with increasing demand for affordable alternatives to branded biologic medications. By acquiring Organon, Sun Pharma would gain a significant foothold in this market, enabling the company to capitalize on the growing demand for biosimilars. The deal would also provide Sun Pharma with the opportunity to leverage Organon’s expertise in developing and commercializing biosimilars, further enhancing the company’s capabilities in this area.
The potential acquisition of Organon is a testament to Sun Pharma’s ambition to become a leading global pharmaceutical player. Under the leadership of Dilip Shanghvi, the company has been actively pursuing strategic acquisitions and partnerships to drive growth and expansion. The acquisition of Organon would be a major milestone in this journey, marking a significant step towards establishing Sun Pharma as a major player in the global pharmaceutical industry.
Overall, the potential acquisition of Organon by Sun Pharma is a significant development in the pharmaceutical industry, with far-reaching implications for the company’s growth and expansion. If successful, the deal would enable Sun Pharma to establish a strong presence in the US market, accelerate its growth in the biosimilars sector, and cement its position as a leading global pharmaceutical player.
US Sales of Revlimid Decline, Offset by Strong Domestic Market Growth
The Indian pharmaceutical industry is bracing for a challenging earnings season in Q3, with expectations of muted margins due to the loss of patent exclusivity for the blockbuster blood cancer drug Revlimid in the US. Revlimid, which has generated over $100 billion in global sales, has been a significant revenue and margin driver for Indian drugmakers such as Dr Reddy’s Laboratories, Cipla, Zydus Lifesciences, and Sun Pharma. However, with the patent expiry in January 2026, these companies will have to offload their remaining quotas, leading to a decline in sales.
Analysts expect a sector-wide decline in earnings before interest, taxes, depreciation, and amortization (Ebitda) margins by 150 basis points year-on-year, with companies such as Dr Reddy’s, Cipla, and Zydus Lifesciences likely to be affected. The decline in Revlimid sales will be a significant contributor to this margin pressure, with prices expected to erode sharply as players look to offload remaining quotas. Additionally, other factors such as increased generic price competition in the US market, higher research and development (R&D) expenses, and rising selling, general, and administrative (SG&A) costs will also weigh on margins.
Despite these challenges, analysts remain optimistic about the sector’s overall revenue growth, with expectations of 8-11% growth driven by steady domestic growth and traction in other markets. Domestic sales are projected to outpace the broader Indian pharmaceutical market’s 10.1% growth, with the chronic segment showing particular strength. Companies such as Lupin, Sun Pharma, and Cipla are expected to see growth driven by their innovative medicines portfolios and recent launches.
The US market, however, is expected to be a challenge, with overall US sales projected to decline by 4% quarter-on-quarter due to lower Revlimid sales. Excluding Revlimid, US generic sales are forecast to grow by 2% quarter-on-quarter, driven by volume expansion in existing products and the benefits from recent launches. Overall, while the loss of Revlimid patent exclusivity will be a significant challenge for Indian pharmaceutical companies, their domestic growth and innovative medicines portfolios are expected to provide some resilience and drive overall revenue growth.
Stock Market Updates for Sun Pharma
Recent Updates
Sun Pharmaceutical Industries suffers loss in trademark dispute as Bombay High Court rules EsiRaft and Raciraft do not bear deceptive similarities.
The Bombay High Court has ruled in favor of Eris Lifesciences, dismissing Sun Pharmaceutical’s claim that Eris’s medication “EsiRaft” infringed on Sun Pharma’s trademark for their medication “Raciraft”. The court found that the names “EsiRaft” and “Raciraft” are not deceptively similar, and therefore, Eris Lifesciences did not infringe on Sun Pharma’s trademark.
Sun Pharma had filed a lawsuit against Eris Lifesciences, alleging that the name “EsiRaft” was too similar to their own medication “Raciraft”, which could cause confusion among consumers. However, the Bombay High Court disagreed, stating that the names are distinct and not likely to cause confusion.
The court noted that the prefix “Esi” in EsiRaft is a well-known abbreviation for Eris Lifesciences, which is a well-established pharmaceutical company. In contrast, the prefix “Raci” in Raciraft is a unique identifier for Sun Pharma’s medication. The court also observed that the suffix “Raft” in both names is a common term used in the pharmaceutical industry to denote a type of medication.
The court’s decision is a significant win for Eris Lifesciences, as it allows the company to continue marketing and selling its medication “EsiRaft” without fear of trademark infringement. The ruling also sets a precedent for the pharmaceutical industry, establishing that minor similarities in medication names do not necessarily constitute trademark infringement.
The case highlights the importance of trademark law in the pharmaceutical industry, where companies invest heavily in developing and marketing their medications. The ruling demonstrates that courts will carefully consider the nuances of trademark law and the potential for consumer confusion when determining whether a trademark infringement has occurred.
In conclusion, the Bombay High Court’s decision in the case of Sun Pharma vs. Eris Lifesciences is a significant victory for Eris Lifesciences, allowing the company to continue marketing its medication “EsiRaft” without fear of trademark infringement. The ruling sets a precedent for the pharmaceutical industry and highlights the importance of careful consideration of trademark law in determining whether a trademark infringement has occurred.
National Pharmaceutical Pricing Authority Caps Retail Price of Sun Pharma’s Gemcitabine Injections
The National Pharmaceutical Pricing Authority (NPPA) has set the retail price for Sun Pharma’s Gemcitabine injections. Gemcitabine is a chemotherapy medication used to treat various types of cancer, including pancreatic, breast, ovarian, and non-small cell lung cancer. The NPPA, which is responsible for regulating the prices of pharmaceutical products in India, has fixed the retail price of Sun Pharma’s Gemcitabine injections to ensure that the medication is affordable for patients.
The price fixation is a significant move, as it will help to make the life-saving medication more accessible to cancer patients in India. Gemcitabine is a critical component of cancer treatment, and its high cost has been a significant burden on patients and their families. The NPPA’s decision is expected to provide relief to patients who are struggling to afford the medication.
The retail price of Sun Pharma’s Gemcitabine injections has been fixed at a level that is significantly lower than the existing market price. This will result in significant savings for patients who are undergoing cancer treatment. The price reduction is expected to benefit thousands of patients who are dependent on Gemcitabine for their treatment.
The NPPA’s decision is in line with the government’s efforts to make healthcare more affordable and accessible to all. The authority has been working to regulate the prices of pharmaceutical products, including cancer medications, to ensure that they are affordable for patients. The price fixation of Gemcitabine is a significant step in this direction and is expected to have a positive impact on the healthcare sector.
The move is also expected to promote competition in the market, as other pharmaceutical companies may be forced to reduce their prices to remain competitive. This will ultimately benefit patients, who will have access to affordable and high-quality medication. The NPPA’s decision is a significant development in the pharmaceutical sector and is expected to have a positive impact on the healthcare industry as a whole.
Overall, the NPPA’s decision to fix the retail price of Sun Pharma’s Gemcitabine injections is a welcome move that will benefit cancer patients in India. The price reduction will make the medication more accessible and affordable, and will help to reduce the financial burden on patients and their families. The move is in line with the government’s efforts to make healthcare more affordable and accessible, and is expected to have a positive impact on the healthcare sector.
Bombay High Court Denies Sun Pharma’s Request for Temporary Restraining Order Against Competitor EsiRaft, Allowing it to Continue Challenging RACIRAFT
The Bombay High Court has refused to grant an interim injunction to Sun Pharmaceutical Industries Limited, allowing Meghmani Lifesciences Limited to continue using the trademark “EsiRaft” for its pharmaceutical product. The court found that the mark is not deceptively similar to Sun Pharma’s “RACIRAFT” and that there is no likelihood of confusion between the two marks.
Sun Pharma had filed a trademark infringement and passing off suit against Meghmani Lifesciences, claiming that the use of “EsiRaft” infringed on its goodwill and was likely to cause confusion among consumers. However, the court held that the marks are visually and phonetically dissimilar and that the element “RAFT” is descriptive of the product’s characteristics and cannot be used to establish deceptive similarity.
The court also noted that the prefixes “RACI” and “ESI” are distinct and that Meghmani Lifesciences’ adoption of the mark was bona fide. The company had explained that “ESI” referred to “Enhanced System Improvement” and “Esophageal Symptom Index”. The court observed that the use of two-color combinations on the packaging was common in the trade and was insufficient to establish infringement.
The court applied the principles of trademark law, including the anti-dissection rule, the viewpoint of an average consumer with imperfect recollection, and the likelihood of confusion. It found that the competing marks are prima facie visually and phonetically dissimilar and will not create any confusion in the minds of consumers.
In dismissing Sun Pharma’s interim injunction plea, the court held that the company had failed to make out a prima facie case of trademark infringement or passing off. The court also vacated an earlier ex-parte ad-interim injunction that had restrained Meghmani Lifesciences from using the disputed mark. The decision allows Meghmani Lifesciences to continue using the “EsiRaft” mark for its product, which is used to treat heartburn and indigestion.
The case highlights the importance of careful consideration of trademark similarity and the need for companies to establish a strong case of infringement or passing off in order to obtain an interim injunction. The court’s decision is significant, as it allows Meghmani Lifesciences to continue marketing its product without interruption, while also protecting the rights of Sun Pharma to pursue its claims in the main suit.
The court’s observation that the get-up of the marks itself is different and the overall visual appearance of the rival products is dissimilar, is crucial in determining the likelihood of confusion. The decision also emphasizes the need for companies to ensure that their trademarks are distinctive and do not infringe on the rights of other companies.
In conclusion, the Bombay High Court’s decision in this case provides guidance on the principles of trademark law and the factors that are considered in determining the likelihood of confusion between two marks. The decision is a significant one, as it allows Meghmani Lifesciences to continue using the “EsiRaft” mark, while also protecting the rights of Sun Pharma to pursue its claims in the main suit.
Sun Pharma Wins Reprieve as CESTAT Sends Back Rs. 3.90 Crore Excise Demand for Re-Assessment Over EOU DTA Sales and Deemed Exports – Juris Hour
The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has remanded a Rs. 3.90 crore excise demand against Sun Pharmaceutical Industries Ltd. regarding sales from an Export Oriented Unit (EOU) to a Domestic Tariff Area (DTA). The tribunal has directed the authorities to recalculate the deemed exports and the corresponding excise duty liability.
The dispute arose from the company’s sales from its EOU to its DTA unit, which were treated as deemed exports under the Export and Import Policy. The excise authorities demanded duty on these sales, claiming that they were not genuine exports. Sun Pharma argued that the sales were eligible for exemption under the exemption notification, as they were deemed exports.
The CESTAT observed that the excise authorities had not properly verified the deemed export benefits claimed by the company. The tribunal noted that the authorities had not considered the export proceeds realized by the company and had not verified the consumption of the goods in the DTA.
The CESTAT held that the excise authorities’ demand was not sustainable and remanded the matter to the original authority to recalculate the deemed exports and the corresponding excise duty liability. The tribunal directed the authorities to consider the export proceeds realized by the company and to verify the consumption of the goods in the DTA.
The CESTAT’s order is significant, as it clarifies the treatment of sales from an EOU to a DTA under the excise law. The order also highlights the importance of proper verification and calculation of deemed export benefits. The remand order will allow the authorities to re-examine the company’s claims and calculate the correct excise duty liability.
The case emphasizes the need for exporters to maintain accurate records and documentation to support their claims for deemed export benefits. It also underscores the importance of proper verification and calculation by the excise authorities to ensure that the correct excise duty liability is determined. The CESTAT’s order will provide guidance to other exporters and excise authorities in similar cases, ensuring consistency and clarity in the application of the excise law.
The US FDA has issued a recall for an antifungal shampoo manufactured by Sun Pharma.
The US Food and Drug Administration (USFDA) has announced a recall of over 17,000 units of antifungal shampoo, Ciclopirox Shampoo, due to manufacturing issues. The recall was initiated by Taro Pharmaceutical Industries, the US arm of Sun Pharma, on December 9. The shampoo is used to treat seborrheic dermatitis, a condition that causes dry, flaky, and itchy skin. The recall was classified as a Class II recall, which means that the product’s use may lead to temporary or medically reversible health consequences, but the likelihood of serious adverse health outcomes is minimal.
The recall was due to “failed impurity/degradation specifications,” according to the USFDA. Taro Pharmaceutical Industries is a private company and a wholly-owned subsidiary of Sun Pharma, which acquired the Israel-based company in a deal valued at $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010. Taro primarily focuses on dermatology and produces a wide range of prescription and over-the-counter products.
The recall is a setback for Sun Pharma, which is a leading exporter to the US market. In the second quarter of FY26, the company reported revenue of Rs 14,478 crore, with a net profit of Rs 3,118 crore, a 2.56% increase year-on-year. However, formulation sales in the US declined 4.1% to $496 million. The recall highlights the importance of quality control and regulatory compliance in the pharmaceutical industry.
The USFDA’s Enforcement Report noted that the recall was nationwide and affected 17,664 units of the Ciclopirox Shampoo. The company has taken prompt action to address the issue, and the recall is expected to minimize any potential harm to consumers. The incident serves as a reminder of the need for pharmaceutical companies to maintain high standards of quality and manufacturing practices to ensure the safety and efficacy of their products.
The Delhi High Court has ruled that a lawsuit filed by Sun Pharma is admissible, citing the company’s online presence as a relevant factor.
The Delhi High Court has ruled that a lawsuit filed by Sun Pharmaceutical Industries against a company selling a product called “PEPFIX-NEOVITAL” is maintainable. The court’s decision was based on the fact that the defendant company has an online presence, which suggests that it is doing business in the Delhi territory.
The lawsuit was filed by Sun Pharma, which claimed that the defendant company was infringing on its trademark by selling a product with a similar name. The defendant company had argued that the court did not have jurisdiction to hear the case, as it was not doing business in Delhi.
However, the court rejected this argument, citing the fact that the defendant company has a website and is selling its products online. The court noted that the website is accessible to customers in Delhi, and that the defendant company is therefore doing business in the territory.
The court’s decision is significant, as it highlights the importance of online presence in determining jurisdiction in intellectual property cases. The ruling suggests that companies with an online presence can be considered to be doing business in a particular territory, even if they do not have a physical presence there.
The case is also notable for its implications for trademark law in India. The court’s decision suggests that companies must be careful to ensure that their online activities do not infringe on the trademarks of other companies. The ruling also highlights the need for companies to be aware of their online presence and to take steps to protect their intellectual property rights in the digital sphere.
In its ruling, the court noted that the defendant company’s website is accessible to customers in Delhi, and that the company is therefore subject to the jurisdiction of the Delhi High Court. The court also noted that the defendant company’s online activities are sufficient to establish a “commercial connection” with the territory, which is a requirement for establishing jurisdiction.
Overall, the Delhi High Court’s ruling in the PEPFIX-NEOVITAL case is an important development in the field of intellectual property law in India. The decision highlights the importance of online presence in determining jurisdiction and the need for companies to be aware of their online activities and to take steps to protect their intellectual property rights.
Sun Pharmaceutical Industries has secured approval from the US Food and Drug Administration for an updated label of UNLOXCYT, incorporating long-term efficacy data for Cutaneous Squamous Cell Carcinoma treatment.
Sun Pharmaceutical Industries Ltd. has received approval from the US Food and Drug Administration (USFDA) for an updated label for its medication UNLOXCYT (tretinoin), which is used to treat a rare skin condition called Cutaneous Squamous Cell Carcinoma (CSCC) in patients with advanced renal cell carcinoma (RCC). The updated label includes long-term efficacy data, demonstrating the treatment’s effectiveness in preventing the progression of CSCC.
UNLOXCYT is a topical formulation of tretinoin, a retinoid that has been shown to inhibit the growth of cancer cells. The medication is specifically designed to treat CSCC, a type of skin cancer that can occur in patients with advanced RCC. The condition is often aggressive and can lead to significant morbidity and mortality if left untreated.
The updated label includes data from a long-term study that evaluated the efficacy of UNLOXCYT in preventing the progression of CSCC in patients with advanced RCC. The study demonstrated that treatment with UNLOXCYT significantly reduced the risk of CSCC progression compared to placebo. The data also showed that UNLOXCYT was well-tolerated, with a safety profile consistent with previous studies.
The approval of the updated label is a significant milestone for Sun Pharma, as it provides healthcare providers with additional confidence in the long-term efficacy of UNLOXCYT in treating CSCC. The company believes that the updated label will help to increase awareness and adoption of the medication among healthcare providers and patients.
The USFDA approval is also a testament to Sun Pharma’s commitment to developing innovative treatments for rare and debilitating diseases. The company has a strong portfolio of specialty and generic products, and is dedicated to improving the lives of patients around the world.
In a statement, a spokesperson for Sun Pharma said, “We are pleased to receive USFDA approval for the updated UNLOXCYT label, which includes long-term efficacy data demonstrating the treatment’s effectiveness in preventing the progression of CSCC. This approval is a significant milestone for our company, and we believe it will help to increase awareness and adoption of UNLOXCYT among healthcare providers and patients.” The updated label is expected to be available in the US market shortly.