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Last Updated: June 15, 2021

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solosec Drug Profile


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Which patents cover Solosec, and when can generic versions of Solosec launch?

Solosec is a drug marketed by Lupin and is included in one NDA. There are four 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 will be eligible for patent challenges on September 15, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for solosec
International Patents:16
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 86
Clinical Trials: 2
Patent Applications: 687
Drug Prices: Drug price information for solosec
What excipients (inactive ingredients) are in solosec?solosec excipients list
DailyMed Link:solosec at DailyMed
Drug patent expirations by year for solosec
Drug Prices for solosec

See drug prices for solosec

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
Lupin Research IncPhase 3
Lupin Research IncPhase 4

See all solosec clinical trials

Pharmacology for solosec

US Patents and Regulatory Information for 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   Get Started Free   Get Started Free   Get Started Free
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Lupin SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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.