Details for New Drug Application (NDA): 022496

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NDA 022496 describes EXPAREL, which is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the EXPAREL profile page.

The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.

Summary for 022496

Tradename:	EXPAREL
Applicant:	Pacira Pharms Inc
Ingredient:	bupivacaine
Patents:	13

Pharmacology for NDA: 022496

Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for 022496

Anesthetics, Local

Suppliers and Packaging for NDA: 022496

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-133	65250-133-04	4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10)
EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496	NDA	Pacira Pharmaceuticals, Inc.	65250-133	65250-133-09	10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	133MG/10ML (13.3MG/ML)
Approval Date:	Oct 28, 2011	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 9, 2026
Regulatory Exclusivity Use:	INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
Regulatory Exclusivity Expiration:	Mar 22, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	11,033,495	Patent Expiration:	Jan 22, 2041	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

Expired US Patents for NDA 022496

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	8,834,921	⤷ Subscribe
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	6,132,766	⤷ Subscribe
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	6,132,766	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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