BUPIVACAINE - Generic Drug Details

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

Bupivacaine is the generic ingredient in sixteen branded drugs marketed by Pacira Pharms Inc, Innocoll, Innocoll Pharms, Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Kindos, Somerset, 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 fifty NDAs. There are thirty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for BUPIVACAINE

International Patents:	69
US Patents:	37
Tradenames:	16
Applicants:	19
NDAs:	50
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1,674
Patent Applications:	6,961
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BUPIVACAINE

Generic Entry Dates for BUPIVACAINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK Dosage: INJECTABLE, LIPOSOMAL;INJECTION
Generic Entry Dates for BUPIVACAINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION, EXTENDED RELEASE;INFILTRATION

^*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 BUPIVACAINE

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

Sponsor	Phase
Yongtao Sun	Phase 4
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	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
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070552-001	May 21, 1986	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hospira	MARCAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 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	022496-002	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	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	022496-002	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 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: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
Slovenia	2767292		⤷ Sign Up
Slovenia	2415484		⤷ Sign Up
United Kingdom	202404737		⤷ Sign Up
Russian Federation	2007114291	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ	⤷ Sign Up
Australia	2005287175	Sustained local anesthetic composition containing preferably a sugar ester such as SAIB	⤷ Sign Up
Slovenia	1809329		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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