FDA Orange Book
Is there a generic for Gemtesa?
Gemtesa contains vibegron. 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 Gemtesa (vibegron). The Orange Book shows its last listed patent expires July 6, 2042 and its last listed exclusivity ends December 18, 2027.
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Gemtesa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 213006, held by SUMITOMO PHARMA AMERICA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gemtesa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8653260 | April 2, 2029 | Drug substance | None | 213006 |
| 12180219 | March 12, 2034 | Drug substance, Drug product | None | 213006 |
| 8247415 | December 23, 2034 | Drug substance, Drug product | U-4219 | 213006 |
| 8247415 | December 23, 2034 | Drug substance, Drug product | U-3045 | 213006 |
| 12102638 | March 22, 2040 | Method of use | U-3045 | 213006 |
| 12357636 | July 6, 2042 | Method of use | U-4219 | 213006 |
Gemtesa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-955 | New indication | December 18, 2027 | 213006 |
Gemtesa NDC codes
Questions
Is there a generic for Gemtesa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gemtesa (vibegron). The Orange Book shows its last listed patent expires July 6, 2042 and its last listed exclusivity ends December 18, 2027.
What is the generic name for Gemtesa?
The active ingredient in Gemtesa is vibegron, per the FDA Orange Book.
When does the Gemtesa patent expire?
The last patent listed for Gemtesa in the Orange Book expires July 6, 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.