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Last Updated: November 2, 2024

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SOLOSEC Drug Patent Profile

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Which patents cover Solosec, and what generic alternatives are available?

Solosec is a drug marketed by Evofem Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has sixteen patent family members in five countries.

The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Solosec

Solosec was eligible for patent challenges on September 15, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 4, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SOLOSEC

International Patents:	16
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Patent Applications:	615
Drug Prices:	Drug price information for SOLOSEC
What excipients (inactive ingredients) are in SOLOSEC?	SOLOSEC excipients list
DailyMed Link:	SOLOSEC at DailyMed

Drug patent expirations by year for SOLOSEC

Drug Prices for SOLOSEC

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

Generic Entry Date for SOLOSEC^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 209363 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 SOLOSEC

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

Sponsor	Phase
Lupin Research Inc	Phase 3
Lupin Research Inc	Phase 4

See all SOLOSEC clinical trials

Pharmacology for SOLOSEC

Drug Class	Nitroimidazole Antimicrobial

US Patents and Regulatory Information for SOLOSEC

SOLOSEC is protected by thirty-two US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOLOSEC is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SOLOSEC

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting SOLOSEC

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS
Exclusivity Expiration: ⤷ Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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

International Patents for SOLOSEC

When does loss-of-exclusivity occur for SOLOSEC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15311674
Patent: Secnidazole for use in the treatment of bacterial vaginosis
Estimated Expiration: ⤷ Sign Up

Patent: 18203882
Patent: Secnidazole for use in the treatment of bacterial vaginosis
Estimated Expiration: ⤷ Sign Up

Patent: 18217262
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 59414
Patent: SECNIDAZOLE UTILISE DANS LE TRAITEMENT D'UNE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 46521
Patent: SECNIDAZOLE A UTILISER DANS LE TRAITEMENT DE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 87534
Estimated Expiration: ⤷ Sign Up

Patent: 37624
Estimated Expiration: ⤷ Sign Up

Patent: 17526697
Patent: 細菌性膣炎の治療に使用するためのセクニダゾール
Estimated Expiration: ⤷ Sign Up

Patent: 19056008
Patent: 細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 20019759
Patent: 細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 21042246
Patent: 細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 170052626
Patent: 세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 190026962
Patent: 세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 200013602
Patent: 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Patent: 200083958
Patent: 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SOLOSEC around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Japan	6637624		⤷ Sign Up
South Korea	20190026962	세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)	⤷ Sign Up
Japan	2017526697	細菌性膣炎の治療に使用するためのセクニダゾール	⤷ Sign Up
Japan	2020019759	細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.