Details for New Drug Application (NDA): 216951
✉ Email this page to a colleague
NDA 216951 describes JESDUVROQ, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the JESDUVROQ profile page.
The generic ingredient in JESDUVROQ is daprodustat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the daprodustat profile page.
The generic ingredient in JESDUVROQ is daprodustat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the daprodustat profile page.
Summary for 216951
| Tradename: | JESDUVROQ |
| Applicant: | Glaxosmithkline |
| Ingredient: | daprodustat |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216951
Generic Entry Date for 216951*:
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: 216951
| Mechanism of Action | Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors |
Suppliers and Packaging for NDA: 216951
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JESDUVROQ | daprodustat | TABLET;ORAL | 216951 | NDA | GlaxoSmithKline LLC | 0173-0897 | 0173-0897-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0897-13) |
| JESDUVROQ | daprodustat | TABLET;ORAL | 216951 | NDA | GlaxoSmithKline LLC | 0173-0903 | 0173-0903-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0903-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 1, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 1, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,117,871 | Patent Expiration: | Mar 13, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD OF TREATING ANEMIA | ||||||||
| Patent: | 11,643,397 | Patent Expiration: | Jun 22, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | A METHOD OF TREATING ANEMIA | ||||||||
Complete Access Available with Subscription
