Orange Book product · Brand (NDA)
TYRVAYA
VARENICLINE TARTRATE
At a glance
Oct 15, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 15, 2021
4 yr 9 mo ago
Today
Patent 10456396 expires
Listed drug product patent expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 11224598 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 11903941 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 11903942 expires
Listed drug product patent expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 11903943 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 11911380 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 12576080 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 9504644 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 9504645 expires
Listed drug product patent expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 9532944 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Patent 9597284 expires
Listed method-of-use patent (U-1900) expiration.
Oct 19, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
VARENICLINE TARTRATE
Strength
EQ 0.03MG BASE/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 213978
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006CHANTIXBrand (NDA)
NDA 021928 · PF PRISM CV
- 2026VARENICLINE TARTRATEGeneric (ANDA)
ANDA 218985 · UMEDICA
- 2025VARENICLINE TARTRATEGeneric (ANDA)
ANDA 218302 · MICRO LABS
- 2025VARENICLINE TARTRATEGeneric (ANDA)
ANDA 213268 · RHODES PHARMS
- 2025VARENICLINE TARTRATEGeneric (ANDA)
ANDA 212879 · VIWIT PHARM
- 2025VARENICLINE TARTRATEGeneric (ANDA)
ANDA 214595 · AUROBINDO PHARMA
- 2025VARENICLINE TARTRATEGeneric (ANDA)
ANDA 216615 · SHILPA
- 2024VARENICLINE TARTRATEGeneric (ANDA)
ANDA 215048 · MACLEODS PHARMS LTD
- 2024VARENICLINE TARTRATEGeneric (ANDA)
ANDA 219106 · REGCON HOLDINGS
- 2024VARENICLINE TARTRATEGeneric (ANDA)
ANDA 215931 · DR REDDYS
- 2024VARENICLINE TARTRATEGeneric (ANDA)
ANDA 217115 · PIRAMAL
- 2024VARENICLINE TARTRATEGeneric (ANDA)
ANDA 213019 · AJANTA PHARMA LTD
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10456396 | Oct 19, 2035 | in 9 yr 6 mo | ProductU-1900 |
| 11224598 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11903941 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11903942 | Oct 19, 2035 | in 9 yr 6 mo | Product |
| 11903943 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 11911380 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 12576080 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9504644 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9504645 | Oct 19, 2035 | in 9 yr 6 mo | Product |
| 9532944 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
| 9597284 | Oct 19, 2035 | in 9 yr 6 mo | U-1900 |
