Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Patent and Exclusivity Search Results from query on Appl No 022012 Product 004 in the OB_Rx list.
|Appl No||Prod No||Patent No||Patent
|N022012||004||6022562||Oct 17, 2015||Y||Y|
|N022012||004||6022562*PED||Apr 17, 2016|
|N022012||004||7268156||Jun 27, 2023||Y||Y||U - 3|
|N022012||004||7268156||Jun 27, 2023||Y||Y||U - 313|
|N022012||004||7268156*PED||Dec 27, 2023|
|N022012||004||8101209||Sep 11, 2025||Y|
|N022012||004||8101209*PED||Mar 11, 2026|
|N022012||004||RE40000||Jun 7, 2015||U - 777|
|N022012||004||RE40000*PED||Dec 7, 2015|
There is no unexpired exclusivity for this product.
- Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
- Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.
View a list of all patent use codes
View a list of all exclusivity codes
FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through August 2014
Patent and Generic Drug Product Data Last Updated September 22, 2014