FLUMAZENIL - Generic Drug Details

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

Flumazenil is the generic ingredient in two branded drugs marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, Sandoz, and Hoffmann La Roche, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for flumazenil. Eight suppliers are listed for this compound.

Summary for FLUMAZENIL

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	49
Patent Applications:	4,532
Drug Prices:	Drug price trends for FLUMAZENIL
What excipients (inactive ingredients) are in FLUMAZENIL?	FLUMAZENIL excipients list
DailyMed Link:	FLUMAZENIL at DailyMed

See drug prices for FLUMAZENIL

Recent Clinical Trials for FLUMAZENIL

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

Sponsor	Phase
Pusan National University Yangsan Hospital	N/A
Yonsei University	N/A
Daegu Catholic University Medical Center	N/A

See all FLUMAZENIL clinical trials

Pharmacology for FLUMAZENIL

Drug Class	Benzodiazepine Antagonist

Medical Subject Heading (MeSH) Categories for FLUMAZENIL

Antidotes
GABA Modulators

Anatomical Therapeutic Chemical (ATC) Classes for FLUMAZENIL

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for FLUMAZENIL

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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
Hikma Farmaceutica	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078527-001	Mar 23, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	077071-001	May 3, 2005	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	077071-002	May 3, 2005	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

Expired US Patents for FLUMAZENIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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