Details for New Drug Application (NDA): 216158
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NDA 216158 describes COBENFY, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the COBENFY profile page.
The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.
The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.
Summary for 216158
| Tradename: | COBENFY |
| Applicant: | Bristol-myers |
| Ingredient: | trospium chloride; xanomeline tartrate |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216158
Generic Entry Date for 216158*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;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: 216158
Suppliers and Packaging for NDA: 216158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COBENFY | trospium chloride; xanomeline tartrate | CAPSULE;ORAL | 216158 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0050 | 0003-0050-14 | 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) |
| COBENFY | trospium chloride; xanomeline tartrate | CAPSULE;ORAL | 216158 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0050 | 0003-0050-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;EQ 50MG BASE | ||||
| Approval Date: | Sep 26, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 26, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,238,643 | Patent Expiration: | Jul 21, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,265,311 | Patent Expiration: | Jul 21, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA IN ADULTS | ||||||||
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