Teflaro Approval and Initial Launch
Teflaro (ceftaroline fosamil), made by Allergan (formerly Forest Laboratories), gained FDA approval in October 2010 for treating acute bacterial skin infections and community-acquired bacterial pneumonia. It launched commercially in the US shortly after, in December 2010.[1]
Key Patents Protecting Teflaro
The main compound patent (US 6,977,274) covers the active ingredient and expires March 14, 2024, with pediatric exclusivity extending it to September 14, 2024. Formulation patents like US 7,919,111 (expires December 31, 2025) and others provide additional barriers. No generic approvals have occurred as of late 2024.[2][3]
Generic Entry Challenges and ANDA Filings
Multiple companies, including Sun Pharma, Aurobindo, and Sandoz, filed Abbreviated New Drug Applications (ANDAs) challenging Teflaro's patents via Paragraph IV certifications. Allergan sued in response, triggering 30-month stays. Sun Pharma settled in 2021, gaining rights to launch no earlier than September 14, 2024—the pediatric exclusivity end date. Other cases, like Allergan v. Aurobindo (resolved 2023), align with similar timelines, but no generics entered by Q4 2024.[2][4]
Expected Generic Launch Date
The earliest generic launch is September 15, 2024, following pediatric exclusivity expiration, assuming no further delays from litigation or FDA hurdles. Sun Pharma's settlement positions it as a likely first filer, eligible for 180-day exclusivity. Track updates on DrugPatentWatch.com for real-time ANDA status and Paragraph IV challenges.[3]
What Could Delay Generics Further?
Pending patents (e.g., device-related US 8,461,369, expires 2029) or new litigation could push launches beyond 2025. Supply issues or FDA review backlogs have slowed similar antibiotics. No generics are approved or launched yet.[2]
Sources:
[1] FDA.gov - Teflaro Approval History (https://www.accessdata.fda.gov/drugsatfdadocs/label/2010/200327lbl.pdf)
[2] FDA Orange Book - Teflaro Patents and Exclusivities (https://www.accessdata.fda.gov/scripts/cder/ob/patentinfo.cfm?ProductNo=001&ApplNo=200327&Appl_type=N)
[3] DrugPatentWatch.com - Teflaro Patent Timeline (https://www.drugpatentwatch.com/p/tradename/TEFLARO)
[4] CourtListener - Allergan v. Sun Pharma (Case 1:21-cv-01792, D. Del.) (https://www.courtlistener.com/docket/59800000/allergan-usa-inc-v-sun-pharma-global-fte-ltd/)