SOLOSEC Drug Patent Profile

When do Solosec patents expire, and when can generic versions of Solosec launch?

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:	102
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

See drug prices for SOLOSEC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOLOSEC

NDA:

209363

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

See all SOLOSEC clinical trials

Pharmacology for SOLOSEC

Drug Class

Nitroimidazole Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for SOLOSEC

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for SOLOSEC

SOLOSEC is protected by thirty-two US patents and four FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting SOLOSEC

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
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y

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

Canada

Japan

South Korea

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	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)
South Korea	20200083958	세균성 질증의 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
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)
Japan	2019056008	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)
South Korea	20190026962	세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Canada	2959414	SECNIDAZOLE UTILISE DANS LE TRAITEMENT D'UNE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)