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Last Updated: March 28, 2024

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 ten 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:10
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022496
Generic Entry Date for 022496*:
Constraining patent/regulatory exclusivity:
INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
Dosage:
INJECTABLE, LIPOSOMAL;INJECTION

*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: 022496
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 022496
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:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength133MG/10ML (13.3MG/ML)
Approval Date:Oct 28, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 9, 2026
Regulatory Exclusivity Use:INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC 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:⤷  Try a TrialPatent Expiration:Jan 22, 2041Product Flag?YSubstance 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

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 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.