BUPIVACAINE HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for bupivacaine hydrochloride and what is the scope of freedom to operate?

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 eighty 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:	80
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:	1,674
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
Yongtao Sun	Phase 4
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018304-003	Approved Prior to Jan 1, 1982	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070966-001	Oct 13, 1987	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Septodont	VIVACAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	077250-001	Sep 27, 2006		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BUPIVACAINE HYDROCHLORIDE KIT	bupivacaine hydrochloride	INJECTABLE;INJECTION	019978-003	Sep 3, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amphastar Pharms Inc	DUOCAINE	bupivacaine hydrochloride; lidocaine hydrochloride	INJECTABLE;INJECTION	021496-001	May 23, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kindos	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	216039-001	Jun 23, 2023	AP	RX	No	No	⤷ 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

International Patents for BUPIVACAINE HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Slovenia	2802624		⤷ Sign Up
Hungary	E043185		⤷ Sign Up
Lithuania	3085363		⤷ Sign Up
Hungary	E043826		⤷ Sign Up
Poland	2139457		⤷ Sign Up
United Kingdom	201220868		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.