DAROLUTAMIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for darolutamide and what is the scope of freedom to operate?
Darolutamide
is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Darolutamide has one hundred and twenty-three patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for DAROLUTAMIDE
| International Patents: | 123 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 62 |
| Patent Applications: | 363 |
| What excipients (inactive ingredients) are in DAROLUTAMIDE? | DAROLUTAMIDE excipients list |
| DailyMed Link: | DAROLUTAMIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAROLUTAMIDE
*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 DAROLUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NRG Oncology | Phase 2 |
| Eli Lilly and Company | Phase 1 |
| Celcuity Inc | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for DAROLUTAMIDE
Paragraph IV (Patent) Challenges for DAROLUTAMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUBEQA | Tablets | darolutamide | 300 mg | 212099 | 1 | 2023-07-31 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for DAROLUTAMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Bayer AG | Nubeqa | darolutamide | EMEA/H/C/004790 NUBEQA is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).- metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1). |
Authorised | no | no | no | 2020-03-27 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DAROLUTAMIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112019018458 | produção de um produto farmacêutico cristalino | ⤷ Sign Up |
| Israel | 193227 | תכשירים המכילים נגזרות של דיציקלופרופיל קרבוקסאניליד לשליטה על המחלות הנגרמות על ידי פטריות פיטופתוגניות (Compositions containing dicyclopropyl carboxanilide derivatives for control of diseases caused by phytopathogenic fungi) | ⤷ Sign Up |
| China | 110382467 | 结晶药物产品的制备 (MANUFACTURE OF CRYSTALLINE PHARMACEUTICAL PRODUCT) | ⤷ Sign Up |
| Hungary | E055528 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAROLUTAMIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2493858 | C20200015 00323 | Estonia | ⤷ Sign Up | PRODUCT NAME: DAROLUTAMIID;REG NO/DATE: EU/1/20/1432 30.03.2020 |
| 1986495 | 1890044-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND MEALAXYL M; NAT. REG. NO/DATE: 5444 20180608; FIRST REG.: NL 15544 N 20171229 |
| 2493858 | C202030032 | Spain | ⤷ Sign Up | PRODUCT NAME: DAROLUTAMIDA, OPCIONALMENTE EN FORMA DE SAL O ESTER FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1432; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1432; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
| 2493858 | CR 2020 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: DAROLUTAMID EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER EN FARMACEUTISK ACCEPTABELT ESTER DERAF; REG. NO/DATE: EU/1/20/1432/001 20200330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
