TINIDAZOLE - Generic Drug Details

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

Tinidazole is the generic ingredient in two branded drugs marketed by Mission Pharma, Chartwell Rx, Edenbridge Pharms, Hikma, and Thinq Pharm-cro Pvt, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tinidazole. Seven suppliers are listed for this compound.

Sponsor

Phase

Shangrong Fan

N/A

Monitor CRO

Phase 1

Exeltis Turkey

Phase 1

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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
Thinq Pharm-cro Pvt	TINIDAZOLE	tinidazole	TABLET;ORAL	202489-001	Oct 9, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	TINIDAZOLE	tinidazole	TABLET;ORAL	201172-002	Apr 30, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618-002	May 17, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Edenbridge Pharms	TINIDAZOLE	tinidazole	TABLET;ORAL	203808-002	Aug 4, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	TINIDAZOLE	tinidazole	TABLET;ORAL	201172-001	Apr 30, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	TINIDAZOLE	tinidazole	TABLET;ORAL	202044-001	Apr 30, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618-001	May 17, 2004	AB	RX	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

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	40
Patent Applications:	6,477
Drug Prices:	Drug price trends for TINIDAZOLE
What excipients (inactive ingredients) are in TINIDAZOLE?	TINIDAZOLE excipients list
DailyMed Link:	TINIDAZOLE at DailyMed