What's New for Vol. 2022, Supp. 08
Changes to patent and exclusivity information

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Cimerli (Injection) (Intravitreal) ranibizumab-eqrn
NDA Applicant: Coherus BioSciences, Inc.      BLA No.: 761165  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML))
ExclusivityExpirationChange
Exclusivity Code: 1st Interchangeable Exclusivity Date TBDNew product in Orange Book

Eylea (Injection) (Intravitreal) aflibercept
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125387  Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
PatentsExpirationChange
Pat. No. 11332771
Serum-free cell culture medium
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New patent for this product

Zynteglo (For Injection) (Intravenous) betibeglogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 RX (1.7-20 X 10^6CELL/ML)
ExclusivityExpirationChange
Exclusivity Code: Ref. Product Exclusivity Aug 17, 2034New product in Orange Book



Last edited: 3 September 2022
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