CEFDINIR - Generic Drug Details

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

Cefdinir is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Lupin, Sandoz, Teva Pharms, and Abbvie, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for cefdinir. Twenty-eight suppliers are listed for this compound.

Summary for CEFDINIR

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	14
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	27
Patent Applications:	7,477
Drug Prices:	Drug price trends for CEFDINIR
Drug Sales Revenues:	Drug sales revenues for CEFDINIR
What excipients (inactive ingredients) are in CEFDINIR?	CEFDINIR excipients list
DailyMed Link:	CEFDINIR at DailyMed

See drug prices for CEFDINIR

See drug sales revenues for CEFDINIR

Recent Clinical Trials for CEFDINIR

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 4
Northeast Ohio Medical University	Phase 2
Mercy Health Ohio	Phase 2

See all CEFDINIR clinical trials

Pharmacology for CEFDINIR

Drug Class	Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CEFDINIR

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 CEFDINIR

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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
Anda Repository	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065429-002	Jul 18, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065337-002	Apr 6, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065332-001	May 4, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	CEFDINIR	cefdinir	CAPSULE;ORAL	065264-001	May 19, 2006	AB	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 CEFDINIR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OMNICEF	cefdinir	CAPSULE;ORAL	050739-001	Dec 4, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-002	Jul 29, 2004	⤷ Sign Up	⤷ Sign Up
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-001	Dec 4, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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