You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

~ Buy the EXPAREL (bupivacaine) Drug Profile, 2024 PDF Report in the Report Store ~

EXPAREL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Exparel patents expire, and what generic alternatives are available?

Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.

This drug has seven patent family members in four countries.

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.

DrugPatentWatch® Generic Entry Outlook for Exparel

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 9, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for EXPAREL
Drug Prices for EXPAREL

See drug prices for EXPAREL

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXPAREL
Generic Entry Date for EXPAREL*:
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
NDA:
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.

Recent Clinical Trials for EXPAREL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johnny K. LeePhase 4
NorthShore University HealthSystemPhase 4
Tufts Medical CenterPhase 3

See all EXPAREL clinical trials

Pharmacology for EXPAREL
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Anatomical Therapeutic Chemical (ATC) Classes for EXPAREL
Paragraph IV (Patent) Challenges for EXPAREL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXPAREL Injectable Suspension bupivacaine 133 mg/10 mL 022496 1 2021-12-28
EXPAREL Injectable Suspension bupivacaine 266 mg/20 mL 022496 1 2021-08-20

US Patents and Regulatory Information for EXPAREL

EXPAREL is protected by ten US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXPAREL is ⤷  Try a Trial.

This potential generic entry date is based on INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EXPAREL

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK OR FEMORAL NERVE BLOCK FOR REGIONAL ANALGESIA

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

Compositions of bupivacaine multivesicular liposomes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA NERVE BLOCK, FOR EXAMPLE, NTERSCALENE BRACHIAL PLEXUS FOR REGIONAL ANALGESIA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

FDA Regulatory Exclusivity protecting EXPAREL

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EXPAREL

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

EU/EMA Drug Approvals for EXPAREL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pacira Ireland Limited Exparel liposomal bupivacaine EMEA/H/C/004586
Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
Authorised no no no 2020-11-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

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.