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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SOLOSEC?
- What are the global sales for SOLOSEC?
- What is Average Wholesale Price for SOLOSEC?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SOLOSEC
*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 |
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
| 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 | ||||
| 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 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.
| 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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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.
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