CEFOTAXIME SODIUM - Generic Drug Details

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What are the generic drug sources for cefotaxime sodium and what is the scope of freedom to operate?

Cefotaxime sodium is the generic ingredient in seven branded drugs marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, Lupin, Sanofi Aventis Us, and Sterimax, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for cefotaxime sodium. One supplier is listed for this compound.

Summary for CEFOTAXIME SODIUM

US Patents:	0
Tradenames:	7
Applicants:	12
NDAs:	17
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	8
Patent Applications:	4,230
DailyMed Link:	CEFOTAXIME SODIUM at DailyMed

Recent Clinical Trials for CEFOTAXIME SODIUM

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

Sponsor	Phase
Fayoum University Hospital	Phase 4
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all CEFOTAXIME SODIUM clinical trials

Pharmacology for CEFOTAXIME SODIUM

Drug Class	Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFOTAXIME SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFOTAXIME SODIUM

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFOTAXIME SODIUM

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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
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-003	Nov 6, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065516-001	Nov 6, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sterimax	CLAFORAN	cefotaxime sodium	INJECTABLE;INJECTION	050547-002	Approved Prior to Jan 1, 1982		DISCN	Yes	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

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