FDA Orange Book
Is there a generic for Qulipta?
Qulipta contains atogepant. 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 Qulipta (atogepant). The Orange Book shows its last listed patent expires February 27, 2043 and its last listed exclusivity ends September 28, 2026.
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Qulipta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 30MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 60MG | Marketed (Rx) | None | 0 | None |
NDA 215206, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qulipta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9499545 | November 10, 2031 | Drug substance, Drug product | U-3534 | 215206 |
| 9850246 | March 13, 2033 | Drug substance | None | 215206 |
| 10117836 | January 30, 2035 | Drug product | None | 215206 |
| 8754096 | September 28, 2035 | Drug substance, Drug product | U-3534 | 215206 |
| 12383545 | June 6, 2039 | Method of use | U-3534 | 215206 |
| 12090148 | July 29, 2041 | Method of use | U-3534 | 215206 |
| 12465598 | September 27, 2042 | Method of use | U-4355 | 215206 |
| 12622897 | September 27, 2042 | Method of use | U-4536 | 215206 |
| 12350259 | February 27, 2043 | Method of use | U-4234 | 215206 |
Qulipta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-909 | New indication | April 17, 2026 | 215206 |
| NCE | New chemical entity | September 28, 2026 | 215206 |
Qulipta NDC codes
Questions
Is there a generic for Qulipta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qulipta (atogepant). The Orange Book shows its last listed patent expires February 27, 2043 and its last listed exclusivity ends September 28, 2026.
What is the generic name for Qulipta?
The active ingredient in Qulipta is atogepant, per the FDA Orange Book.
When does the Qulipta patent expire?
The last patent listed for Qulipta in the Orange Book expires February 27, 2043. 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 Qulipta and Atogepant
- What is Qulipta used for?FDA label uses
- Is Qulipta a controlled substance?Federal schedule
- Calcitonin Gene-related Peptide Receptor Antagonists listFDA drug class
- Qulipta Medicare Part D coverageBy plan and state
- NDC 0074-7094Qulipta NDC record
- NDC 0074-7095Qulipta NDC record
- NDC 0074-7096Qulipta NDC record