Apotex's Initial ANDA Filing for Ruxolitinib
Apotex filed its Abbreviated New Drug Application (ANDA) No. 208665 for a generic version of ruxolitinib (Jakafi/Incyte Corp.) on September 23, 2016, as a Paragraph IV challenge to multiple Orange Book patents.[1][2]
FDA Acceptance and GDUFA Goal Date
The FDA accepted the ANDA for review on December 22, 2016, triggering a 30-month Generic Drug User Fee Amendments (GDUFA) goal date of June 22, 2019.[1][2]
Patent Litigation Filings
Incyte sued Apotex in the U.S. District Court for the District of Delaware on January 5, 2017, alleging infringement of patents including U.S. Patent Nos. 7,598,257; 8,415,401; 8,461,199; 9,090,554; and 9,469,638 (expiring 2027-2031). Apotex countered that the patents were invalid or not infringed.[3][4]
Court Rulings on Infringement and Validity
In May 2019, the court ruled all asserted claims valid and infringed, denying Apotex's motion for summary judgment. A bench trial occurred October 28-November 1, 2019.[3]
FDA Tentative Approval
Despite the litigation, the FDA granted tentative approval to Apotex's ANDA on May 28, 2020, indicating the application met all standards except final patent or exclusivity resolution.[1][2]
Final Judgment and Injunction
On September 29, 2020, the Delaware court issued final judgment for Incyte, permanently enjoining Apotex from commercial marketing until patent expiry. Apotex's appeal to the Federal Circuit followed.[3][5]
Appeal Outcome
The Federal Circuit affirmed the district court's infringement and validity rulings on May 25, 2022, upholding the injunction.[5]
Current Status
Apotex's ANDA remains tentatively approved but blocked by the injunction. No commercial launch date is set, pending patent expirations starting in 2027.[1][2]
Sources:
[1] FDA Orange Book entry for ANDA 208665
[2] DrugPatentWatch.com - Ruxolitinib patent litigation timeline
[3] Delaware District Court docket, Incyte v. Apotex (1:17-cv-00157)
[4] Complaint filing, January 5, 2017
[5] Federal Circuit decision, 2022-1105, May 25, 2022