FDA Orange Book
Is there a generic for Tyrvaya?
Tyrvaya contains varenicline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tyrvaya (varenicline). The Orange Book shows its last listed patent expires October 19, 2035.
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Tyrvaya products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | EQ 0.03MG BASE/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 213978, held by OYSTER POINT PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tyrvaya patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11224598 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 10456396 | October 19, 2035 | Drug product | U-1900 | 213978 |
| 9597284 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 9532944 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 9504644 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 11911380 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 11903943 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 11903941 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 12576080 | October 19, 2035 | Method of use | U-1900 | 213978 |
| 12653824 | October 19, 2035 | Drug product | None | 213978 |
| 9504645 | October 19, 2035 | Drug product | None | 213978 |
| 11903942 | October 19, 2035 | Drug product | None | 213978 |
Tyrvaya NDC codes
Questions
Is there a generic for Tyrvaya?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tyrvaya (varenicline). The Orange Book shows its last listed patent expires October 19, 2035.
What is the generic name for Tyrvaya?
The active ingredient in Tyrvaya is varenicline, per the FDA Orange Book.
When does the Tyrvaya patent expire?
The last patent listed for Tyrvaya in the Orange Book expires October 19, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Tyrvaya and Varenicline
- What is Tyrvaya used for?FDA label uses
- Is Tyrvaya a controlled substance?Federal schedule
- What is Varenicline used for?FDA label uses
- Is Varenicline a controlled substance?Federal schedule
- Generic for ChantixFDA Orange Book
- Partial Cholinergic Nicotinic Agonists listFDA drug class
- Cholinergic Receptor Agonists listFDA drug class
- NDC 73521-030Tyrvaya NDC record