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Last Updated: May 9, 2024

Bupivacaine hydrochloride - Generic Drug Details

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

Bupivacaine hydrochloride is the generic ingredient in thirteen branded drugs marketed by 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, and Amphastar Pharms Inc, and is included in forty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has seventy-nine patent family members in twenty-three countries.

There are six drug master file entries for bupivacaine hydrochloride. Nineteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

International Patents:	79
US Patents:	2
Tradenames:	13
Applicants:	16
NDAs:	47
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	1,623
Patent Applications:	1,076
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in bupivacaine hydrochloride?	bupivacaine hydrochloride excipients list
DailyMed Link:	bupivacaine hydrochloride at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
National Trauma Center	N/A
Johnny K. Lee	Phase 4

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

Drug Class	Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine hydrochloride

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for bupivacaine hydrochloride

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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
Steriscience	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-001	Oct 18, 2011	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071167-001	Jun 16, 1988		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070586-001	Mar 3, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kindos	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	216039-001	Jun 23, 2023	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kindos	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	216040-001	Dec 27, 2023	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

International Patents for bupivacaine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Mexico	368037	COLÁGENO MODIFICADO. (A MODIFIED COLLAGEN.)	⤷ Try a Trial
Denmark	3085363		⤷ Try a Trial
Eurasian Patent Organization	201491278	МОДИФИЦИРОВАННЫЙ КОЛЛАГЕН	⤷ Try a Trial
European Patent Office	3901218	COLLAGÈNE MODIFIÉ (A MODIFIED COLLAGEN)	⤷ Try a Trial
Spain	2645445		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.