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Last Updated: May 26, 2022

SOLOSEC Drug Patent Profile


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When do Solosec patents expire, and when can generic versions of Solosec launch?

Solosec is a drug marketed by Lupin and is included in one NDA. There are seven 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:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 94
Clinical Trials: 2
Patent Applications: 771
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

See drug prices for SOLOSEC

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SOLOSEC
Generic Entry Date for SOLOSEC*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Lupin Research IncPhase 3
Lupin Research IncPhase 4

See all SOLOSEC clinical trials

US Patents and Regulatory Information for SOLOSEC

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOLOSEC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of trichomoniasis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of trichomoniasis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of trichomoniasis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS

Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

FDA Regulatory Exclusivity protecting SOLOSEC

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Patent: 18203882
Estimated Expiration: See Plans and Pricing

Patent: 18217262
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59414
Estimated Expiration: See Plans and Pricing

Patent: 46521
Estimated Expiration: See Plans and Pricing

Japan

Patent: 87534
Estimated Expiration: See Plans and Pricing

Patent: 37624
Estimated Expiration: See Plans and Pricing

Patent: 17526697
Estimated Expiration: See Plans and Pricing

Patent: 19056008
Estimated Expiration: See Plans and Pricing

Patent: 20019759
Estimated Expiration: See Plans and Pricing

Patent: 21042246
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170052626
Estimated Expiration: See Plans and Pricing

Patent: 190026962
Estimated Expiration: See Plans and Pricing

Patent: 200013602
Estimated Expiration: See Plans and Pricing

Patent: 200083958
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2016037131 See Plans and Pricing
South Korea 20200083958 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) See Plans and Pricing
South Korea 20200013602 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) See Plans and Pricing
Japan 2021042246 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) See Plans and Pricing
Australia 2018217262 See Plans and Pricing
Japan 6487534 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Merck
Colorcon
McKesson
Harvard Business School

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.