Secnidazole - Generic Drug Details

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

Secnidazole is the generic ingredient in one branded drug marketed by Evofem Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Secnidazole has sixteen patent family members in five countries.

There are two drug master file entries for secnidazole. One supplier is listed for this compound.

Summary for secnidazole

International Patents:	16
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Patent Applications:	1,096
What excipients (inactive ingredients) are in secnidazole?	secnidazole excipients list
DailyMed Link:	secnidazole at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for secnidazole

Generic Entry Date for secnidazole^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for secnidazole

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

Sponsor	Phase
Indiana University	Phase 2/Phase 3
Lupin Pharmaceuticals, Inc.	Phase 2/Phase 3
Lupin Research Inc	Phase 3

See all secnidazole clinical trials

Pharmacology for secnidazole

Drug Class	Nitroimidazole Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for secnidazole

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for secnidazole

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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
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 secnidazole

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Country	Patent Number	Title	Estimated Expiration
Japan	6487534		⤷ Sign Up
Japan	6637624		⤷ Sign Up
South Korea	20200013602	세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)	⤷ Sign Up
Australia	2015311674	Secnidazole for use in the treatment of bacterial vaginosis	⤷ Sign Up
South Korea	20170052626	세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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