FDA Orange Book
Is there a generic for Tryptyr?
Tryptyr contains acoltremon. 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 Tryptyr (acoltremon). The Orange Book shows its last listed patent expires December 16, 2042 and its last listed exclusivity ends May 28, 2030.
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Tryptyr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.003% | Marketed (Rx) | None | 0 | None |
NDA 217370, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tryptyr patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10028920 | September 8, 2031 | Method of use | U-1900 | 217370 |
| 9433679 | September 8, 2031 | Method of use | U-1900 | 217370 |
| 9095609 | September 8, 2031 | Drug product | U-1900 | 217370 |
| 11850221 | December 16, 2042 | Drug product | U-1900 | 217370 |
| 12336971 | December 16, 2042 | Method of use | U-1900 | 217370 |
Tryptyr exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 28, 2030 | 217370 |
Tryptyr NDC codes
Questions
Is there a generic for Tryptyr?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tryptyr (acoltremon). The Orange Book shows its last listed patent expires December 16, 2042 and its last listed exclusivity ends May 28, 2030.
What is the generic name for Tryptyr?
The active ingredient in Tryptyr is acoltremon, per the FDA Orange Book.
When does the Tryptyr patent expire?
The last patent listed for Tryptyr in the Orange Book expires December 16, 2042. 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.