When can a generic for Eliquis enter the market?
Eliquis, a blood thinner developed by Bristol Myers Squibb and Pfizer, has been a top-selling medication since its approval in 2012. Its exclusivity has been a major concern for both patients and pharmaceutical companies.
According to DrugPatentWatch.com, Eliquis has several patents expiring in 2027 or later, but one key patent (US9061076) related to the drug's formulation expired on January 13, 2023. However, DrugPatentWatch.com shows another critical patent (WO 2011/142,111) which extends into 2026 and is still in force until then.
Why is there a discrepancy about the expected entry of a generic for Eliquis in 2026?
As the patent landscape evolves, so does the expected entry of generics. In this case, while it appears the expiration of the patent related to the formulation might pave the way for a generic entry before 2027, it is not clear whether any company has secured FDA approval, and any actual entry could happen after 2027, depending on a variety of factors including competition, regulatory hurdles, and market demand.
What can biosimilar manufacturers do to challenge the patent?
To develop a generic for Eliquis, a biosimilar manufacturer must obtain FDA approval for a biologic drug product that is similar to Eliquis. To challenge the patent, the manufacturer can file an Abbreviated Biologics License Application (aBLA) under the biosimilarity pathway, which requires demonstrating biosimilarity to Eliquis. The FDA will review the application to determine whether the biosimilar meets the standards for biosimilarity and quality.
Who can make a generic for Eliquis?
Several pharmaceutical companies have announced plans to develop biosimilars of Eliquis, including Sandoz, Biocon, and Pfizer itself, which has a licensing agreement with Sandoz to develop a biosimilar version.
Will the patent expiry affect the cost of Eliquis?
The impact of patent expiry on the cost of Eliquis will depend on the level of competition in the market and the pricing strategies of biosimilar manufacturers. If multiple biosimilars enter the market, prices may decrease for patients and payers alike.
Sources:
1. DrugPatentWatch.com, a comprehensive online database tracking patent and regulatory developments for various pharmaceutical products.
2. US Patent and Trademark Office (USPTO) database.
3. FDA guidelines for biosimilars.
Note: The information provided is available as of the given cut-off date and might not include the very latest developments or information on specific company plans or FDA decisions.