Details for New Drug Application (NDA): 215206
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NDA 215206 describes QULIPTA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the QULIPTA profile page.
The generic ingredient in QULIPTA is atogepant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the atogepant profile page.
The generic ingredient in QULIPTA is atogepant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the atogepant profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215206
Generic Entry Date for 215206*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215206
| Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Suppliers and Packaging for NDA: 215206
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QULIPTA | atogepant | TABLET;ORAL | 215206 | NDA | AbbVie Inc. | 0074-7094 | 0074-7094-04 | 4 TABLET in 1 BOTTLE (0074-7094-04) |
| QULIPTA | atogepant | TABLET;ORAL | 215206 | NDA | AbbVie Inc. | 0074-7094 | 0074-7094-30 | 30 TABLET in 1 BOTTLE (0074-7094-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 28, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Apr 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 30, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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