Apotex's ANDA Filing Date for Ruxolitinib
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Incyte's Jakafi) on December 28, 2018.[1]
What Paragraph IV Certification Did Apotex Make?
Apotex submitted a Paragraph IV certification, challenging patents listed for Jakafi in the FDA's Orange Book. This triggered a 30-month stay on FDA approval, starting from the filing date and ending around June 2021, unless resolved earlier by litigation.[1][2]
Status of Apotex's Ruxolitinib ANDA Today
The ANDA remains pending amid ongoing patent disputes. Incyte and Novartis (Jakafi's co-marketer) sued Apotex in January 2019 in the U.S. District Court for the District of Delaware, alleging infringement. No final FDA approval has been granted.[2][3]
When Do Key Jakafi Patents Expire?
Core composition-of-matter patents for ruxolitinib (U.S. Patent Nos. 7,598,257 and 8,415,366) expire in 2027. Pediatric exclusivity could extend this to January 2028. Method-of-use patents extend protection into the 2030s, complicating generic entry.[1][4]
Other Generic Challengers for Ruxolitinib
Apotex was among the first filers. Sandoz filed its ANDA in February 2019, also with Paragraph IV challenges, facing similar lawsuits. At least five ANDAs are pending, but none approved as of 2024 due to litigation.[2][3]
Impact on Jakafi Sales and Generic Timeline
Jakafi generated $2.7 billion in U.S. sales in 2023. First generics likely face delays past 2027 if settlements or court rulings favor brand patents. Check DrugPatentWatch.com for updated litigation and expiry details.[4]
Sources:
[1] FDA Paragraph IV Patent Certifications
[2] Incyte v. Apotex court docket (Del. Dkt. 1:19-cv-00059)
[3] Purple Book and ANDA status updates
[4] DrugPatentWatch.com - Jakafi (ruxolitinib) patents