FDA Orange Book
Is there a generic for Ubrelvy?
Ubrelvy contains ubrogepant. 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 Ubrelvy (ubrogepant). The Orange Book shows its last listed patent expires December 22, 2041.
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Ubrelvy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 211765, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ubrelvy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9499545 | November 10, 2031 | Drug substance, Drug product | U-2718 | 211765 |
| 9833448 | November 10, 2031 | Method of use | U-2718 | 211765 |
| 8754096 | July 19, 2032 | Drug substance, Drug product | U-2717 | 211765 |
| 8912210 | December 23, 2033 | Drug substance, Drug product | None | 211765 |
| 12220408 | January 30, 2035 | Drug product | None | 211765 |
| 12458632 | January 30, 2035 | Drug product | None | 211765 |
| 11925709 | January 30, 2035 | Drug product | None | 211765 |
| 12168004 | January 30, 2035 | Drug product | None | 211765 |
| 10117836 | January 30, 2035 | Drug product | None | 211765 |
| 12310953 | January 30, 2035 | Drug product | None | 211765 |
| 12458633 | January 30, 2035 | Drug product | None | 211765 |
| 11717515 | December 22, 2041 | Method of use | U-3677 | 211765 |
| 12329750 | December 22, 2041 | Method of use | U-4213 | 211765 |
| 12194030 | December 22, 2041 | Method of use | U-4121 | 211765 |
| 12194030 | December 22, 2041 | Method of use | U-4122 | 211765 |
| 11857542 | December 22, 2041 | Method of use | U-3786 | 211765 |
| 12070450 | December 22, 2041 | Method of use | U-3992 | 211765 |
Ubrelvy NDC codes
Questions
Is there a generic for Ubrelvy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ubrelvy (ubrogepant). The Orange Book shows its last listed patent expires December 22, 2041.
What is the generic name for Ubrelvy?
The active ingredient in Ubrelvy is ubrogepant, per the FDA Orange Book.
When does the Ubrelvy patent expire?
The last patent listed for Ubrelvy in the Orange Book expires December 22, 2041. 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.
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