Secnidazole - Generic Drug Details
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What are the generic drug sources for secnidazole and what is the scope of patent protection?
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
*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 |
|---|---|
| Lupin Pharmaceuticals, Inc. | Phase 2/Phase 3 |
| Indiana University | Phase 2/Phase 3 |
| Lupin Research Inc | Phase 3 |
Pharmacology for secnidazole
| Drug Class | Nitroimidazole Antimicrobial |
Anatomical Therapeutic Chemical (ATC) Classes for secnidazole
US Patents and Regulatory Information for secnidazole
| 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 | ⤷ 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 | |||
| >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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Sign Up |
| South Korea | 20200013602 | 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) | ⤷ Sign Up |
| South Korea | 20200083958 | 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) | ⤷ Sign Up |
| Japan | 6487534 | ⤷ Sign Up | |
| Australia | 2018203882 | Secnidazole for use in the treatment of bacterial vaginosis | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2016037131 | ⤷ Sign Up | |
| Canada | 3046521 | SECNIDAZOLE A UTILISER DANS LE TRAITEMENT DE VAGINOSE BACTERIENNE (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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