FDA Orange Book · active-ingredient family
Varenicline tartrate
Varenicline tartrate is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TYRVAYA · NDA 213978
2
Brand (NDA)
21
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · spray, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TYRVAYARLD | OYSTER POINT PHARMA | NDA 213978 | — | Oct 15, 2021 | |
| CHANTIXRLD×2 | PF PRISM CV | NDA 021928 | AB | May 10, 2006 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VARENICLINE TARTRATE×2 | UMEDICA | ANDA 218985 | AB | Jan 09, 2026 | |
| VARENICLINE TARTRATE×2 | MICRO LABS | ANDA 218302 | AB | Oct 29, 2025 | |
| VARENICLINE TARTRATE×2 | RHODES PHARMS | ANDA 213268 | — | May 21, 2025 | |
| VARENICLINE TARTRATE×2 | VIWIT PHARM | ANDA 212879 | AB | May 06, 2025 | |
| VARENICLINE TARTRATE×2 | AUROBINDO PHARMA | ANDA 214595 | AB | May 02, 2025 | |
| VARENICLINE TARTRATE×2 | SHILPA | ANDA 216615 | AB | Apr 08, 2025 | |
| VARENICLINE TARTRATE×2 | MACLEODS PHARMS LTD | ANDA 215048 | AB | Dec 09, 2024 | |
| VARENICLINE TARTRATE×2 | REGCON HOLDINGS | ANDA 219106 | AB | Oct 29, 2024 | |
| VARENICLINE TARTRATE×2 | DR REDDYS | ANDA 215931 | AB | Oct 01, 2024 | |
| VARENICLINE TARTRATE×2 | PIRAMAL | ANDA 217115 | AB | Jul 23, 2024 | |
| VARENICLINE TARTRATE×2 | AJANTA PHARMA LTD | ANDA 213019 | AB | Mar 19, 2024 | |
| VARENICLINE TARTRATE×2 | NE RX PHARMA | ANDA 217283 | AB | Mar 06, 2024 | |
| VARENICLINE TARTRATE×2 | PHARMOBEDIENT | ANDA 202019 | — | Feb 28, 2024 | |
| VARENICLINE TARTRATE×2 | LUPIN | ANDA 211862 | AB | Dec 04, 2023 | |
| VARENICLINE TARTRATE×2 | HETERO LABS LTD III | ANDA 214571 | AB | Oct 23, 2023 | |
| VARENICLINE TARTRATE×2 | ALKEM LABS LTD | ANDA 214557 | AB | Aug 23, 2023 | |
| VARENICLINE TARTRATE×2 | MANKIND PHARMA | ANDA 214255 | AB | Aug 01, 2023 | |
| VARENICLINE TARTRATE×2 | KANCHAN HLTHCARE | ANDA 217151 | AB | Jul 25, 2023 | |
| VARENICLINE TARTRATE×2 | ZYDUS | ANDA 216723 | AB | Jun 12, 2023 | |
| VARENICLINE TARTRATE×2 | APOTEX | ANDA 201962 | AB | Jan 25, 2023 | |
| VARENICLINE TARTRATE×2 | PH HEALTH | ANDA 201785 | AB | Aug 11, 2021 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11224598 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 10456396 | Oct 19, 2035 | in 9 yr 6 mo | ProductU-1900 |
| 9597284 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9532944 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9504644 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11911380 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11903943 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11903941 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 12576080 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9504645 | Oct 19, 2035 | in 9 yr 6 mo | Product |
| 11903942 | Oct 19, 2035 | in 9 yr 6 mo | Product |
Varenicline tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
