Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209363

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NDA 209363 describes SOLOSEC, which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SOLOSEC profile page.

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.
Summary for 209363
Tradename:SOLOSEC
Applicant:Lupin
Ingredient:secnidazole
Patents:1
Generic Entry Opportunity Date for 209363
Generic Entry Date for 209363*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
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.

Pharmacology for NDA: 209363
Suppliers and Packaging for NDA: 209363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLOSEC secnidazole GRANULE;ORAL 209363 NDA Lupin Pharmaceuticals, Inc. 27437-051 27437-051-01 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) > 2 g in 1 PACKET
SOLOSEC secnidazole GRANULE;ORAL 209363 NDA Lupin Pharmaceuticals, Inc. 27437-051 27437-051-02 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) > 2 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength2GM/PACKET
Approval Date:Sep 15, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 15, 2027
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Sep 15, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 4, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

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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 verifification 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.