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EXPAREL Drug Patent Profile

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Which patents cover Exparel, and what generic alternatives are available?

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

This drug has eight 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

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

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Summary for EXPAREL

International Patents:	8
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	280
Patent Applications:	4,699
Drug Prices:	Drug price information for EXPAREL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXPAREL
What excipients (inactive ingredients) are in EXPAREL?	EXPAREL excipients list
DailyMed Link:	EXPAREL at DailyMed

Drug patent expirations by year for EXPAREL

Recent Clinical Trials for EXPAREL

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 3
Jessyka Lighthall	Phase 3
Rutgers, The State University of New Jersey	Phase 2/Phase 3

See all EXPAREL clinical trials

Pharmacology for EXPAREL

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

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 fourteen US patents and two FDA Regulatory Exclusivities.

Patents protecting EXPAREL

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

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Patent Expiration: ⤷ Sign Up
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

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Patent Expiration: ⤷ Sign Up
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

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Patented Use: A METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE REGIONAL ANALGESIA VIA SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA IN ADULTS

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Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA

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Patented Use: A METHOD OF TREATING PAIN BY ADMINISTERING BUPIVACAINE VIA LOCAL INFILTRATION IN PEDIATRIC PATIENTS AGED 6 TO LESS THAN 12 YEARS OLD UNDERGOING CARDIAC SURGERY

FDA Regulatory Exclusivity protecting EXPAREL

NEW PATIENT POPULATION
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INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	022496-002	Oct 28, 2011	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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

EU/EMA Drug Approvals for EXPAREL

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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

International Patents for EXPAREL

See the table below for patents covering EXPAREL around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	0729351	VESICULES A TAUX CONTROLE DE LIBERATION DES PRINCIPES ACTIFS (VESICLES WITH CONTROLLED RELEASE OF ACTIVES)	⤷ Sign Up
Australia	2008203032		⤷ Sign Up
New Zealand	276305	CONTROLLED RELEASE VESICLE COMPOSITIONS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration