Daprodustat - Generic Drug Details
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What are the generic sources for daprodustat and what is the scope of patent protection?
Daprodustat
is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Daprodustat has forty-two patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for daprodustat
| International Patents: | 42 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 15 |
| Patent Applications: | 98 |
| What excipients (inactive ingredients) are in daprodustat? | daprodustat excipients list |
| DailyMed Link: | daprodustat at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for daprodustat
Generic Entry Date for daprodustat*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Recent Clinical Trials for daprodustat
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| USRC Kidney Research | Phase 4 |
| GlaxoSmithKline | Phase 4 |
| Quintiles, Q2 Solutions, HemoCue, ERT | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for daprodustat
US Patents and Regulatory Information for daprodustat
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-002 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-002 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-001 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-001 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-002 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-001 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Glaxosmithkline | JESDUVROQ | daprodustat | TABLET;ORAL | 216951-004 | Feb 1, 2023 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for daprodustat
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 061570 | COMPUESTO DE GLICINA SUSTITUIDO EN EL N HETEROAROMATICO COMPOSICION FARMACEUTICA QUE LO COMPRENDE, SU USO PARA PREPARAR UN MEDICAMENTO, PROCEDIMIENTOS PARA PREPARAR DICHA COMPOSICION FARMACEUTICA Y PARA PREPARAR EL COMPUESTO | ⤷ Subscribe |
| Australia | 2007260837 | Prolyl hydroxylase inhibitors | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2019052133 | ⤷ Subscribe | |
| South Africa | 200810602 | Prolyl hydroxylase inhibitors | ⤷ Subscribe |
| Japan | 2020533396 | ＧＳＫ１２７８８６３の結晶形及びその製造方法並びに医薬用途 | ⤷ Subscribe |
| Malaysia | 149861 | PROLYL HYDROXYLASE INHIBITORS | ⤷ Subscribe |
| Spain | 2453100 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
