Details for New Drug Application (NDA): 208261
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NDA 208261 describes ZEPATIER, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZEPATIER profile page.
The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.
The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.
Summary for 208261
| Tradename: | ZEPATIER |
| Applicant: | Msd Sub Merck |
| Ingredient: | elbasvir; grazoprevir |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208261
Generic Entry Date for 208261*:
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: 208261
Suppliers and Packaging for NDA: 208261
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261 | NDA | Merck Sharp & Dohme LLC | 0006-3074 | 0006-3074-02 | 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;100MG | ||||
| Approval Date: | Jan 28, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 9, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 24, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 4, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS | ||||||||
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