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Last Updated: March 29, 2024

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 seven patents protecting this drug. Additional details are available on the UBRELVY profile page.

The generic ingredient in UBRELVY is ubrogepant. 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:7
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
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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 23, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 23, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:Jan 30, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 22, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE HEPATIC IMPAIRMENT

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.