EXPAREL Drug Patent Profile

When do Exparel patents expire, and when can generic versions of Exparel launch?

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

This drug has sixteen patent family members in five 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 have been seven patent litigation cases 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

Summary for EXPAREL

International Patents:	16
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	303
Patent Applications:	4,749
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

See drug prices for EXPAREL

Recent Clinical Trials for EXPAREL

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

Sponsor	Phase
Wake Forest University Health Sciences	PHASE3
Atrium Health Levine Cancer Institute	PHASE3
Second Affiliated Hospital, School of Medicine, Zhejiang University	EARLY_PHASE1

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 twenty-four US patents and one FDA Regulatory Exclusivity.

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		RX	Yes	Yes	11,278,494		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,144,890		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,156,940		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	11,931,459
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes

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	8,182,835
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	9,585,838
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	9,205,052

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/004586Exparel 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

International Patents for EXPAREL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2603047	Manufacturing of bupivacaine multivesicular liposomes
European Patent Office	1030652	Production de liposomes multivesiculaires (Production of multivesicular liposomes)
Japan	H09505301
Hungary	T75162
European Patent Office	4032528