Teflaro's Key Patents and Expiry Dates
Teflaro (ceftaroline fosamil), developed by Cerexa and now marketed by Allergan (an AbbVie company after acquisition), has several patents listed in the FDA's Orange Book. The primary product patent, US 6,977,274, covers the compound and expires in 2020.[1] AbbVie holds related formulation and method-of-use patents extending protection, with the latest (US 9,505,737 for acetate form) expiring in 2034.[1][2]
When Does Teflaro's Market Exclusivity End?
Pediatric exclusivity adds six months to the main patent term, pushing the effective end of the primary patent protection to mid-2020. However, AbbVie's secondary patents, including those for manufacturing processes, maintain exclusivity against generics until at least 2034, barring successful challenges.[1][2]
Why Might Generics Still Face Delays?
Multiple AbbVie patents overlap, covering crystalline forms (expiring 2032–2034) and uses for conditions like pneumonia. No generics are approved yet, as ANDA filers must certify around these via Paragraph IV challenges, which could trigger litigation.[1][2]
Who Makes Teflaro and Recent Patent Activity?
Allergan, acquired by AbbVie in 2020, licenses Teflaro globally. Recent updates show no major expirations imminent; check DrugPatentWatch.com for real-time Paragraph IV challenges and evergreening attempts.[2]
[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Teflaro entry.
[2] DrugPatentWatch.com, Teflaro patent dashboard (accessed via public database).