Details for New Drug Application (NDA): 215206

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 five patents protecting this drug. Additional details are available on the QULIPTA profile page.

The generic ingredient in QULIPTA is atogepant. One supplier is listed for this compound. Additional details are available on the atogepant profile page.

Summary for 215206

Tradename:	QULIPTA
Applicant:	Abbvie
Ingredient:	atogepant
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215206

Constraining patent/regulatory exclusivity:

10,117,836

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:	10,117,836	Patent Expiration:	Jan 30, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

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