Bupivacaine - Generic Drug Details

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What are the generic sources for bupivacaine and what is the scope of patent protection?

Bupivacaine is the generic ingredient in fifteen branded drugs marketed by Pacira Pharms Inc, Innocoll, Innocoll Pharms, Civica, Eugia Pharma, Hikma Pharms, Hospira, Steriscience, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, Amphastar Pharms Inc, and Heron Theraps Inc, and is included in forty-six NDAs. There are twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-five patent family members in thirty countries.

There are twelve drug master file entries for bupivacaine. Three suppliers are listed for this compound.

Summary for bupivacaine

International Patents:	65
US Patents:	29
Tradenames:	15
Applicants:	16
NDAs:	46
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	1,570
Patent Applications:	6,941
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for bupivacaine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupivacaine
What excipients (inactive ingredients) are in bupivacaine?	bupivacaine excipients list
DailyMed Link:	bupivacaine at DailyMed

See drug prices for bupivacaine

Recent Clinical Trials for bupivacaine

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

Sponsor	Phase
Montefiore Medical Center	Phase 1
New Valley University	Phase 2/Phase 3
Basaksehir Cam & Sakura Şehir Hospital	N/A

See all bupivacaine clinical trials

Pharmacology for bupivacaine

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for bupivacaine

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPIVACAINE

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 bupivacaine

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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
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070597-001	Mar 3, 1987	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-005	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 bupivacaine

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

EU/EMA Drug Approvals for bupivacaine

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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 (see section 5.1):• 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 bupivacaine

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2415484	Composition anesthésique locale prolongée contenant du SAIB (Sustained local anesthetic composition containing SAIB)	See Plans and Pricing
South Africa	200702373	Sustained local anesthetic composition containing preferably a sugar ester such as saib	See Plans and Pricing
Norway	20071914		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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