Details for New Drug Application (NDA): 216386

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NDA 216386 describes ZAVZPRET, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ZAVZPRET profile page.

The generic ingredient in ZAVZPRET is zavegepant hydrochloride. Two suppliers are listed for this compound. Additional details are available on the zavegepant hydrochloride profile page.

Summary for 216386

Tradename:	ZAVZPRET
Applicant:	Pfizer
Ingredient:	zavegepant hydrochloride
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216386

Generic Entry Date for 216386^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY Dosage: SPRAY, METERED;NASAL

^*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: 216386

Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Suppliers and Packaging for NDA: 216386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386	NDA	Pfizer Laboratories Div Pfizer Inc	0069-3500	0069-3500-02	6 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE
ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386	NDA	U.S. Pharmaceuticals	63539-135	63539-135-02	1 BLISTER PACK in 1 CARTON (63539-135-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	EQ 10MG BASE/SPRAY
Approval Date:	Mar 9, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 9, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Subscribe	Patent Expiration:	Jan 21, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Oct 7, 2031	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	ADMINISTRATION OF ZAVEGEPANT FOR ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

Expired US Patents for NDA 216386

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	⤷ Subscribe	⤷ Subscribe
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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