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Last Updated: March 28, 2024

Secnidazole - Generic Drug Details


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What are the generic drug sources for secnidazole and what is the scope of freedom to operate?

Secnidazole is the generic ingredient in one branded drug marketed by Lupin 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

SponsorPhase
Indiana UniversityPhase 2/Phase 3
Lupin Pharmaceuticals, Inc.Phase 2/Phase 3
Lupin Research IncPhase 3

See all secnidazole clinical trials

Pharmacology 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
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
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 secnidazole

Country Patent Number Title Estimated Expiration
Canada 2959414 SECNIDAZOLE UTILISE DANS LE TRAITEMENT D'UNE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) ⤷  Try a Trial
Australia 2018203882 Secnidazole for use in the treatment of bacterial vaginosis ⤷  Try a Trial
Australia 2018217262 ⤷  Try a Trial
South Korea 20200083958 세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) ⤷  Try a Trial
Canada 3046521 SECNIDAZOLE A UTILISER DANS LE TRAITEMENT DE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS) ⤷  Try a Trial
>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.