DrugPatentWatch Database Preview
Darolutamide - Generic Drug Details
What are the generic drug sources for darolutamide and what is the scope of patent protection?
Darolutamide
is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Darolutamide has ninety-four patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for darolutamide
| International Patents: | 94 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 36 |
| Patent Applications: | 56 |
| What excipients (inactive ingredients) are in darolutamide? | darolutamide excipients list |
| DailyMed Link: | darolutamide at DailyMed |
Recent Clinical Trials for darolutamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| UNICANCER | Phase 3 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 |
| NRG Oncology | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for darolutamide
US Patents and Regulatory Information for darolutamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 darolutamide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 3056485 | ⤷ Try it Free |
| South Korea | 20080095275 | ⤷ Try it Free |
| European Patent Office | 3885340 | ⤷ Try it Free |
| Spain | 2402655 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for darolutamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2493858 | C20200015 00323 | Estonia | ⤷ Try it Free | PRODUCT NAME: DAROLUTAMIID;REG NO/DATE: EU/1/20/1432 30.03.2020 |
| 2493858 | 132020000000064 | Italy | ⤷ Try it Free | PRODUCT NAME: DAROLUTAMIDE(NUBEQA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1432, 20200330 |
| 1986495 | 19C1035 | France | ⤷ Try it Free | PRODUCT NAME: COMPOSITION COMPRENANT SEDAXANE OU UN TAUTOMERE DE CE COMPOSE, FLUDIOXONIL ET METALAXYL-M; NAT. REGISTRATION NO/DATE: 2180766 20181218; FIRST REGISTRATION: NL - 15544N 20171229 |
| 2493858 | 2020C/514 | Belgium | ⤷ Try it Free | PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
