SECNIDAZOLE - Generic Drug Details
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What are the generic 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
Generic Entry Date for SECNIDAZOLE*:
Constraining patent/regulatory exclusivity:
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 SECNIDAZOLE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Indiana University | Phase 2/Phase 3 |
Lupin Pharmaceuticals, Inc. | 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 | ⤷ 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 | 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
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