SOLOSEC Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Solosec, and what generic alternatives are available?
Solosec is a drug marketed by Lupin 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
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: | 699 |
| 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
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
| Sponsor | Phase |
|---|---|
| Lupin Research Inc | Phase 3 |
| Lupin Research Inc | Phase 4 |
Pharmacology for SOLOSEC
| Drug Class | Nitroimidazole Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for SOLOSEC
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Secnidazole for use in the treatment of bacterial vaginosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Secnidazole for use in the treatment of trichomoniasis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN ADULTS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
FDA Regulatory Exclusivity protecting SOLOSEC
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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: ⤷ Try a Trial
Patent: 18203882
Estimated Expiration: ⤷ Try a Trial
Patent: 18217262
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 59414
Estimated Expiration: ⤷ Try a Trial
Patent: 46521
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 87534
Estimated Expiration: ⤷ Try a Trial
Patent: 37624
Estimated Expiration: ⤷ Try a Trial
Patent: 17526697
Estimated Expiration: ⤷ Try a Trial
Patent: 19056008
Estimated Expiration: ⤷ Try a Trial
Patent: 20019759
Estimated Expiration: ⤷ Try a Trial
Patent: 21042246
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 170052626
Estimated Expiration: ⤷ Try a Trial
Patent: 190026962
Estimated Expiration: ⤷ Try a Trial
Patent: 200013602
Estimated Expiration: ⤷ Try a Trial
Patent: 200083958
Estimated Expiration: ⤷ Try a Trial
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 | 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) | ⤷ Try a Trial |
| Australia | 2018217262 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| Australia | 2015311674 | Secnidazole for use in the treatment of bacterial vaginosis | ⤷ Try a Trial |
| South Korea | 20200013602 | 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
