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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213426


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NDA 213426 describes SEGLENTIS, which is a drug marketed by Kowa Pharms and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the SEGLENTIS profile page.

The generic ingredient in SEGLENTIS is celecoxib; tramadol hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the celecoxib; tramadol hydrochloride profile page.
Summary for 213426
Tradename:SEGLENTIS
Applicant:Kowa Pharms
Ingredient:celecoxib; tramadol hydrochloride
Patents:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213426
Generic Entry Date for 213426*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength56MG;44MG
Approval Date:Oct 15, 2021TE:RLD:Yes
Patent:⤷  Get Started FreePatent Expiration:Apr 19, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
Patent:⤷  Get Started FreePatent Expiration:Apr 19, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Get Started FreePatent Expiration:Apr 19, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB

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