BUPIVACAINE HYDROCHLORIDE - Generic Drug Details

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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

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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
Huons	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	212822-001	Dec 30, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	205141-002	Feb 11, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-010	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

International Patents for BUPIVACAINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013104687		⤷ Sign Up
Denmark	3536748		⤷ Sign Up
Hungary	E027803		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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