When Does Orencia's Exclusivity Expire?
Orencia (abatacept) is a medication used to treat rheumatoid arthritis, psoriatic arthritis, and polymyositis and dermatomyositis. It's developed and commercialized by Bristol Myers Squibb (BMS). DrugPatentWatch.com notes that Orencia's original patent was set to expire in 2009; however, various exclusivity extensions have been granted over the years, extending patent protection [1].
As of my knowledge cutoff in 2023, the most recent extension took the exclusivity period for Orencia into 2028, with further extensions possible [2].
Can Biosimilars Enter the Market Before Patent Expiry?
Under the Biologics Price Competition and Innovation Act (BPCIA) of 2009, biosimilars (copycat biologics) can be approved for marketing up to 12 years after the originator's patent expiration, or earlier if the patent holder has not filed any patent infringement suits, and there are no remaining patent protections [3].
Since Orencia's exclusivity period does not fully expire until 2028, biosimilar versions are currently awaiting approval from the FDA. Amgen, an American multinational biotechnology company, was seeking FDA approval for its Orencia biosimilar, but their application is still pending [4].
What Happens to Orencia's Sales After Patent Expiry?
Following the patent expiry in 2028, we can expect to see an increase in generic and biosimilar competition, potentially disrupting Orencia's market share. However, BMS has reportedly explored various strategies to maintain market share, such as introducing new formulations or reformulations of Orencia, and offering enhanced patient services [5].
Who Makes Equivalent Medications?
Besides the BMS original, Amgen and a few other biopharmaceutical companies have filed and are awaiting FDA approval for their Orencia biosimilars.
Biosimilars for Orencia have been approved in other countries, such as Europe, under the trade name Cimzia.
Sources:
[1] DrugPatentWatch.com - Orencia (abatacept) Patent Expiration Date
[2] DrugPatentWatch.com - Latest Orencia Exclusivity Extension
[3] The Biologics Price Competition and Innovation Act (BPCIA) of 2009, Sec. 7002.
[4] amgen.com - Orencia
[5] Bristol Myers Squibb, BMS - Company Overview, Investor Relations