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

Qulipta products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral10MGMarketed (Rx)None0None
tablet, oral30MGMarketed (Rx)None0None
tablet, oral60MGMarketed (Rx)None0None

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

Patents listed for Qulipta
PatentExpiresCoversUse codeNDA
9499545November 10, 2031Drug substance, Drug productU-3534215206
9850246March 13, 2033Drug substanceNone215206
10117836January 30, 2035Drug productNone215206
8754096September 28, 2035Drug substance, Drug productU-3534215206
12383545June 6, 2039Method of useU-3534215206
12090148July 29, 2041Method of useU-3534215206
12465598September 27, 2042Method of useU-4355215206
12622897September 27, 2042Method of useU-4536215206
12350259February 27, 2043Method of useU-4234215206

Qulipta exclusivity

Exclusivity listed for Qulipta
CodeMeaningExpiresNDA
I-909New indicationApril 17, 2026215206
NCENew chemical entitySeptember 28, 2026215206

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.

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