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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the celecoxib; tramadol hydrochloride profile page.
The generic ingredient in SEGLENTIS is celecoxib; tramadol hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed 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.
Pharmacology for NDA: 213426
| Mechanism of Action | Cyclooxygenase Inhibitors Full Opioid Agonists |
Suppliers and Packaging for NDA: 213426
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEGLENTIS | celecoxib; tramadol hydrochloride | TABLET;ORAL | 213426 | NDA | Kowa Pharmaceuticals America, Inc. | 66869-564 | 66869-564-30 | 1 BOTTLE, PLASTIC in 1 CARTON (66869-564-30) / 30 TABLET in 1 BOTTLE, PLASTIC |
| SEGLENTIS | celecoxib; tramadol hydrochloride | TABLET;ORAL | 213426 | NDA | Kowa Pharmaceuticals America, Inc. | 66869-564 | 66869-564-35 | 35 TABLET in 1 BOTTLE, PLASTIC (66869-564-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 56MG;44MG | ||||
| Approval Date: | Oct 15, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 15, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,238,668 | Patent Expiration: | Apr 19, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB | ||||||||
| Patent: | 10,245,276 | Patent Expiration: | Apr 19, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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