Aurobindo Pharma
Aurobindo Pharma secures FDA nod for generic version of Xarelto.
Aurobindo Pharma, a leading Indian pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for the generic equivalent of Xarelto (Rivaroxaban), a popular anticoagulant drug. The generic version, Rivaroxaban Tablets, will be used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone knee or hip replacement surgery.
Xarelto is a blockbuster drug developed by Johnson & Johnson and is marketed by Bayer. According to Aurobindo Pharma, it is one of the most widely used oral anticoagulant drugs, with over 1.5 million prescriptions filled in the US alone in 2020. However, it is notoriously difficult to manufacture and has been the subject of several patent disputes.
Aurobindo Pharma’s generic version of Xarelto is the first to receive FDA approval and will be available in the US market in the coming weeks. The company claims that its generic version is identical in composition, strength, and dosage form to the branded version, and is therefore substitutable.
The approval is significant for Aurobindo Pharma, which has been aggressively pursuing FDA approvals for generic versions of blockbuster drugs. The company has over 200 ANDA (Abbreviated New Drug Application) filings pending with the FDA, including several for complex products such as Xarelto.
The pricing of Aurobindo Pharma’s generic Xarelto will likely be significantly lower than the branded version, which could potentially disrupt the market dynamics. The branded Xarelto is currently priced at around $120 per 20-mg tablet, while Aurobindo Pharma’s generic version will be priced much lower, around $4-5 per tablet.
The generic approval is also seen as a shot in the arm for India’s pharmaceutical industry, which has been under pressure due to rising competition from China and patent-related issues. Aurobindo Pharma’s success will likely encourage other Indian companies to invest in developing generic versions of complex products, which could help to reduce the country’s dependence on branded drugs.
In conclusion, Aurobindo Pharma’s FDA approval for the generic equivalent of Xarelto is a significant development in the pharmaceutical industry, particularly for the Indian company and the country’s pharma sector as a whole. The generic version is expected to be priced lower than the branded version, which could disrupt the market dynamics and provide patients with a more affordable option.
Aurobindo Pharma receives US FDA approval for Rivaroxaban Tablets
Aurobindo Pharma, a generic drugmaker, has received final approval from the US FDA to manufacture and market Rivaroxaban Tablets USP in the strength of 2.5 mg. This approval is based on the company’s demonstration of bioequivalence and therapeutic equivalence to the reference listed drug Xarelto 2.5 mg of Janssen Pharmaceuticals Inc. The company plans to launch the product by June, following the approval.
Rivaroxaban Tablet USP is used to treat various conditions, including nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, and for the prophylaxis of blood clots in patients undergoing knee or hip replacement surgery. The approved product has an estimated US market size of $447 million for the 12 months ending February 2025.
Aurobindo Pharma has also received tentative approval from the US FDA for Rivaroxaban Tablets USP in strengths of 10 mg, 15 mg, and 20 mg. The estimated US market size for all strengths of Rivaroxaban tab USP is $8.5 billion for the 12 months ending February 2025.
Aurobindo Pharma’s North Carolina plant faces 11 US FDA observations
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A sub-contracting company of Aurobindo Pharma, Aurolife Pharma LLC’s, inhalers and derma products manufacturing plant in North Carolina, USA, has received 11 observations from the US Food and Drug Administration (FDA) following a recent inspection. The FDA conducted the inspection at the plant from March 24 to April 10. The observations made by the FDA are procedural in nature, meaning they relate to operational practices rather than the product’s quality or safety.
Aurobindo Pharma, a leading generic pharmaceutical company, owns Aurolife Pharma LLC, which operates the plant in question. The company has stated that the observations should not have a significant impact on the current operations or existing supplies from the facility. Aurobindo Pharma has also committed to submitting a comprehensive response to the FDA within the given time frame, addressing each of the 11 observations and outlining the corrective and preventive actions that will be taken.
The FDA inspection and the subsequent observations are an essential part of ensuring the quality and safety of pharmaceutical products. The regulatory body conducts regular inspections at manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMPs). While the observations made are procedural in nature, they should not cause major disruptions to the manufacturing operations or the supplies produced by the facility.
Aurolife Pharma LLC is one of the several U.S.-based facilities owned and operated by Aurobindo Pharma. The company continues to maintain a strong presence in the US market, following a merger and acquisition strategy that has expanded its global footprint.
Aurobindo Pharma’s stance on the matter is that the observations should not influence the current business operations, indicating that they are focused on putting the necessary corrective and preventive measures in place as soon as possible. This will ensure that the facility can continue to meet regulatory requirements and supply high-quality pharmaceutical products to the U.S. market.
In conclusion, the 11 observations made by the FDA do not pose a significant threat to Aurobindo Pharma’s business operations or existing supplies from the affected facility. The company will respond to the FDA’s concerns and implement steps to rectify the procedural issues, maintaining the safety and quality of their products.
Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 pharmacokinetic study of investigational bone drug.
Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, has successfully completed a Phase 1 pharmacokinetics study for its investigational bone drug. The study aimed to evaluate the drug’s ability to maintain a stable level in the bloodstream over a prolonged period.
The Phase 1 study was a randomized, open-label, single-dose escalation design, involving 24 healthy male subjects. Participants received a single dose of the investigational bone drug, and pharmacokinetic (PK) parameters were measured to assess the drug’s absorption, distribution, metabolism, and elimination (ADME) profile.
The study results showed that the investigational bone drug was well-tolerated, with no serious adverse events reported. The study also demonstrated that the drug follows a predictable PK profile, with a rapid absorption and elimination, and a relatively small variability in exposure across participants.
The successful completion of this study is a significant milestone for CuraTeQ Biologics, as it sets the stage for further clinical development of the investigational bone drug. The company plans to continue evaluating the safety and efficacy of the drug in larger, more detailed studies, with the goal of submitting a new drug application to regulatory authorities in the future.
The investigational bone drug, a humanized monoclonal antibody, is being developed as a potential treatment for osteoporosis and related bone disorders. It is designed to selectively target a specific protein responsible for bone dissolution, thereby reducing bone loss and improving bone density.
Overall, the successful completion of this Phase 1 study is an important step forward in the development of this innovative treatment for bone disorders. CuraTeQ Biologics’ work has the potential to bring a new and effective therapy to patients with osteoporosis and related conditions, and the company is committed to advancing this research through further clinical trials and regulatory submissions.
US Announces Plans to Impose Tariffs on Pharma Imports: Impact on India’s $8.7 Billion Market
The US government, under President Donald Trump, has announced plans to impose new tariffs on pharmaceutical imports, which could significantly impact India, the top supplier of generic drugs to the US. The move aims to push pharmaceutical manufacturing back to the US, but analysts warn that it could have far-reaching consequences for both countries. India’s pharmaceutical sector, which generates a significant portion of its revenue from the US market, could face major setbacks. Indian companies such as Dr Reddy’s, Aurobindo Pharma, Sun Pharma, Zydus Lifesciences, and Gland Pharma, which rely on the US market for a substantial part of their revenue, may be particularly affected.
The tariffs, expected to be “major,” could lead to increased costs for US consumers and insurers, and potentially cause inflation and drug shortages. The US heavily relies on low-cost Indian generics to maintain affordability in healthcare, and a tariff regime could disrupt this arrangement. Indian drugmakers already operate on tight margins, and tariffs would force them to raise prices, making their products less competitive in the US market.
As the US government continues to develop its trade policy, Indian pharma exports may face an uncertain future, further adding pressure to the industry grappling with FDA compliance challenges. The US-India trade relationship is already under strain, and the tariff move could exacerbate tensions between the two nations. Analysts warn that both countries will bear the brunt of this move, which could set back India’s competitiveness in the global pharmaceutical market.
Aurobindo Pharma’s arm gets nod from European Commission to commercialise Dyrupeg.
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Aurobindo Pharma, a leading pharmaceutical company, has announced that its arm, Rare Disease K.K, has received permission from the European Commission to market Dyrupeg, a novel medicine for patients with Trisomy 21 (Down syndrome).
According to the European Commission’s decision, Rare Disease K.K will be allowed to market Dyrupeg for the treatment of respiratory and sleep disorders in patients with Down syndrome. This decision is based on the positive outcome of the company’s application for marketing authorization, which was reviewed by the European Medicines Agency (EMA).
Dyrupeg, a inhalation drug, is designed to treat respiratory and sleep disorders, which are common comorbidities in patients with Down syndrome. This disorder can lead to sleep apnea, hypopneas, and other breathing disorders, which can significantly impact a patient’s quality of life.
The European Commission’s decision is a significant milestone for Aurobindo Pharma, as it marks the company’s entry into the rare disease market. Rare Disease K.K is a wholly-owned subsidiary of Aurobindo Pharma, which specializes in the development and commercialization of orphan medicines.
The company’s CEO, N. Govindaraju, has expressed his appreciation for the European Commission’s decision, stating that it is a testament to the company’s commitment to developing innovative medicines for rare diseases. He also highlighted the company’s ability to work closely with regulatory authorities to bring new treatments to patients in need.
With this marketing authorization, Rare Disease K.K is now poised to bring Dyrupeg to the European market, providing a new treatment option for patients with Down syndrome. This decision is expected to have a significant impact on the company’s growth prospects and strengthen its position in the rare disease market.
Overall, Aurobindo Pharma’s success in securing marketing approval for Dyrupeg demonstrates its ability to develop innovative medicines that address unmet medical needs. The company’s commitment to rare disease research and development is likely to position it for long-term growth and success in the pharmaceutical industry.
AbbVie accuses Aurobindo of infringing Rinvoq patent with its generic version.
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AbbVie, a pharmaceutical company, has filed a patent infringement lawsuit in the Delaware federal court against Aurobindo Pharma over the company’s tentatively approved generic version of the immunosuppressant drug Rinvoq. The lawsuit marks the latest development in a series of intellectual property disputes surrounding the treatment.
Rinvoq, which is used to treat conditions such as rheumatoid arthritis and ulcerative colitis, is a top-selling drug for AbbVie, earning billions of dollars in revenue annually. The company has sought to protect its intellectual property rights over the drug, particularly its patent for the product.
Aurobindo Pharma, a generic drug manufacturer, had submitted a President’s Citizen Petition to the FDA seeking to approve its own generic version of Rinvoq. However, AbbVie argues that the approval of Aurobindo’s generic version would infringe on its patent rights and the company is now challenging the approval in federal court.
The lawsuit comes after AbbVie’s patent for Rinvoq was rejected by an Administrative Law Judge at the US Patent and Trademark Office, but the company is challenging the approval of Aurobindo’s generic version in court. The case is likely to involve complex patent law and intellectual property disputes.
A Law360 article reports on the lawsuit and provides updates on ongoing litigation over Rinvoq. Law360 is a subscription-based news service that offers expert analysis, daily newsletters, and real-time alerts on the latest developments in law and the legal industry. With over 200 articles published daily, Law360 covers more than 60 topics, industries, practice areas, and jurisdictions.
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Citi cites low risk of US tariffs on Indian pharma, favoring Torrent Pharma and Divi’s.
Citibank has analyzed the potential impact of US tariffs on Indian pharmaceutical companies and has assigned a low probability to such an event. The brokerage firm simulated a 10% tariff scenario and found that companies with a high exposure to US generics, such as Zydus, Dr. Reddy’s Laboratories, and Aurobindo Pharma, could face a 9-12% reduction in earnings before interest, taxes, depreciation, and amortization (EBITDA). However, if part of the tariffs is passed on to buyers, the impact could be reduced to 5-6%.
On the other hand, companies with lower exposure to US generics, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories, would be less affected, with an estimated 1-3% hit to EBITDA. Citi’s preferred picks in the Indian pharmaceutical sector, these companies have diversified portfolios and are less reliant on the US generics market.
The report also notes that if tariffs are imposed, they may not be fully passed on to US buyers due to various factors, including competition, industry fragmentation, and the influence of buying consortiums focused on lowering prices. Citi believes that the probability of tariffs on Indian generics is low, citing the limited manufacturing of generics in the US, the high dependence on Indian generics, and the risk of drug shortages if Indian suppliers exit the market.
The brokerage firm concludes that while the imposition of tariffs is a low-probability event, the potential impact on Indian pharmaceutical companies varies significantly based on their exposure to the US generics market. Overall, the report suggests that investors should focus on companies with diversified portfolios and lower reliance on the US generics market, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories.
Citi predicts low risk of US tariffs on Indian pharma, with Torrent Pharma and Divi’s being favored picks.
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Citi, a brokerage firm, has analyzed the potential impact of US tariffs on Indian pharmaceutical companies. While the likelihood of such a scenario is low, Citi’s analysis suggests that certain companies could face a significant hit to their earnings if tariffs are imposed. Companies with high exposure to the US generics market, such as Zydus, Dr. Reddy’s Laboratories, and Aurobindo Pharma, could see a 9-12% reduction in earnings before interest, taxes, depreciation, and amortization (Ebitda). However, this impact could be mitigated if part of the tariffs are passed on to buyers, which is considered challenging.
On the other hand, companies with lower exposure to the US generics market, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories, would be the least affected, with an estimated 1-3% hit to Ebitda. Citi recommends these companies as preferred picks in the Indian pharmaceutical sector due to their diversified portfolios and lower reliance on the US generics market.
The report also notes that even if tariffs are imposed, they may not be fully passed on to US buyers due to various factors, including competition, industry fragmentation, and the influence of buying consortiums focused on lowering prices. Additionally, products facing competition from US players or those from non-tariff countries might not see any pass-through of tariffs.
Citi believes the probability of tariffs on Indian generics is low, citing the limited manufacturing of generics in the US, the high dependence on Indian generics, and the risk of drug shortages if Indian suppliers exit the market. The firm emphasizes that tariffs, if not passed through, could make some Indian generics unviable for the US market.
Overall, while the imposition of tariffs remains a low-probability event, Citi’s outlook suggests that the potential impact on Indian pharmaceutical companies varies significantly based on their exposure to the US generics market.
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Federal Circuit, 2025) and counselled by McDonnell Boehnen Hulbert & Berghoff LLP.
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The patent dispute in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. is about the calculation of patent term extension (PTE) for a reissued patent. Aurobindo, one of the defendants in the ANDA (abbreviated new drug application) litigation, argued that PTE should be calculated based on the grant date of the reissued patent, not the original patent. Merck, the plaintiff, contended that PTE should be calculated from the grant date of the original patent. The Federal Circuit agreed with Merck, finding that the reissue patent inherited the unexpired term of the original patent.
The case involves a reissued patent for sugammadex, a medication used to assist patients in recovering from muscle function after surgery. The original patent, U.S. Patent No. 6,670,340, issued in 2003, and the reissue patent, U.S. Reissue Patent No. RE44,733, was granted in 2014. Aurobindo argued that PTE should be calculated based on the grant date of the reissued patent, not the original patent. Merck argued that PTE should be calculated from the grant date of the original patent, citing 35 U.S.C. § 156 and the Intellectual Property Green Book (MPEP section 2766).
The District Court and the Federal Circuit both rejected Aurobindo’s argument, finding that the original patent grant date should be used to calculate PTE. The Court held that using the original patent grant date aligns with the congressional intent to compensate pharmaceutical companies for the delay in obtaining FDA approval, which is the purpose of the Hatch-Waxman Act. The Court also found that Aurobindo’s interpretation would undermine the purpose of the Hatch-Waxman Act and create unintended results.
The Federal Circuit opinion was written by Circuit Judge Dyk and joined by Judges Mayer and Reyna. The panel concluded that the original patent grant date should be used to calculate PTE, citing 35 U.S.C. § 156(c) and the Intellectual Property Green Book (MPEP section 2766). The panel also noted that Aurobindo’s argument would deny Merck compensation for the majority of the delay, which is not in line with congressional intent. The opinion acknowledges that the panel’s interpretation is consistent with the PTO’s construction of the statute and the overwhelming number of cases in which the issue has arisen.
Aurobindo’s US Sugammadex Patent Lapses After Five-Year Extension RejectedThis version maintains the same information and keywords as the original, but is phrased in a more concise and natural way.
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The US Court of Appeals for the Federal Circuit has issued a precedential decision in a case involving Merck’s reissued patent, entitled “To Full Patent-Term Extension”. The case centers around Aurobindo’s bid to invalidate a reissued patent that shields Merck & Co’s Bridion (Sugammadex) injectable. Specifically, Aurobindo argued that the patent-term extension granted to Merck did not comply with the requirements of the Hatch-Waxman Act, which allows for a five-year extension of the patent term for certain patents that include a patent term extension.
The crux of the case is the interpretation of the language “the patent” in the context of patent-term extensions for reissued patents. The Federal Circuit held that the language “the patent” in the context of patent-term extensions for reissued patents refers not to the original patent, but rather to the reissued patent itself. This determination is precedential, meaning that it sets a legal precedent for future cases.
The court’s ruling is significant, as it clarifies the scope of patent-term extensions for reissued patents, which are often seen as a way to obtain market exclusivity for innovative medical treatments. In this case, the ruling is a win for Merck, as it allows the company to retain its exclusivity period for Bridion, a medication used to reverse the effects of over-sedation during anesthesia. The ruling also sets a precedent for future cases involving reissued patents and patent-term extensions.
The implications of this decision are far-reaching, as it provides guidance to patent owners, generic drug manufacturers, and the pharmaceutical industry at large. The ruling demonstrates the importance of careful drafting and clarification of legal language, as even seemingly simple phrases like “the patent” can have significant consequences in court. With this decision, the Federal Circuit has provided much-needed clarity in a complex area of patent law, and its impact will be felt for years to come.
Aurobindo Pharma Terminates Vaccine License Agreement with Hilleman Labs
Aurobindo Pharma, a pharmaceutical company, has terminated its licensing agreement with Hilleman Laboratories Singapore Pte Ltd for the development, manufacturing, and commercialization of a pediatric pentavalent vaccine candidate. The agreement was signed in September 2023 and was set to expire in 2025. As Auro Vaccines, the subsidiary responsible for the vaccine development, is not a material part of the company, Aurobindo Pharma expects the termination to have no significant impact on its financials or subsidiaries.
The agreement required Auro Vaccines to make milestone payments to Hilleman Laboratories upon achieving specific development and clinical study outcomes, as well as pay royalties to the Singapore-based company once the vaccine candidate was commercialized. Despite the termination, Aurobindo Pharma is not expected to experience any significant impact, and the company will make any necessary disclosures if the situation changes in the future.
The termination is viewed as a “non-material event” by Aurobindo Pharma, which suggests that the company does not expect to incur any substantial financial losses or liabilities as a result. This decision may indicate that the company is re-evaluating its priorities and focusing on more promising opportunities. As the deal was still in its early stages, the termination may not have significant implications for the pharmaceutical industry or the development of pediatric vaccines.
Unleashing New Frontiers: Aurobindo Pharma’s Diversification Drive Paves the Way for Future Growth
Aurobindo Pharma, a leading drugmaker, is focusing on sustaining profitability and turnover in the face of rising global uncertainties. According to Chief Financial Officer Santhanam Subramanian, the company’s strategy is centered on scale and diversity, with a goal of expanding into new verticals such as injectables, peptides, and biosimilars. This diversification will help minimize the impact of a potential tariff hike in the US and maintain margins.
Aurobindo has been steadily expanding its presence in the market, starting with a small API business in India, followed by the US, Europe, and other parts of the world. The company is also entering the Chinese market, which is expected to contribute to its growth in 2-3 years.
The company’s diversified portfolio allows it to overcome the risks associated with price erosion, as 10% of its top products account for 20% of its US turnover. Aurobindo does not differentiate between “bread and butter” and high-growth segments, nurturing all verticals independently to ensure consistent contribution to overall growth.
In terms of cash flow generation, Aurobindo is planning to expand its existing projects and open new plants, including a US-based plant and a biosimilar facility. The company’s strong cash flow generation allows it to strategically allocate capital towards new verticals and expansion projects.
Aurobindo’s net debt stands at $84 million, with projections to generate $200-300 million annually. The company has a robust product pipeline, with over 850 ANDAs filed and 150-200 awaiting approval. The new verticals of biosimilars, Eutect, Terany, and Biologics are expected to drive growth in the coming years.
Overall, Aurobindo Pharma is confident in its ability to sustain healthy margins and drive growth through its focus on scale and diversity, robust cash flow generation, and strong product pipeline.