Details for New Drug Application (NDA): 211765
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NDA 211765 describes UBRELVY, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the UBRELVY profile page.
The generic ingredient in UBRELVY is ubrogepant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ubrogepant profile page.
The generic ingredient in UBRELVY is ubrogepant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ubrogepant profile page.
Summary for 211765
| Tradename: | UBRELVY |
| Applicant: | Abbvie |
| Ingredient: | ubrogepant |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211765
Generic Entry Date for 211765*:
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: 211765
| Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Suppliers and Packaging for NDA: 211765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UBRELVY | ubrogepant | TABLET;ORAL | 211765 | NDA | Allergan, Inc. | 0023-6498 | 0023-6498-01 | 1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET |
| UBRELVY | ubrogepant | TABLET;ORAL | 211765 | NDA | Allergan, Inc. | 0023-6498 | 0023-6498-04 | 4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 23, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,117,836 | Patent Expiration: | Jan 30, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,717,515 | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE HEPATIC IMPAIRMENT | ||||||||
| Patent: | 11,857,542 | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE RENAL IMPAIRMENT | ||||||||
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