Darolutamide - Generic Drug Details
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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Darolutamide has one hundred and twenty-two patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for darolutamide
| International Patents: | 122 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 54 |
| 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
Generic Entry Date for darolutamide*:
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.
Recent Clinical Trials for darolutamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| D'Or Institute for Research and Education | Phase 2 |
| Eli Lilly and Company | Phase 1/Phase 2 |
| Bayer | 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Mexico | 2019010452 | FABRICACION DE UN PRODUCTO FARMACEUTICO CRISTALINO. (MANUFACTURE OF A CRYSTALLINE PHARMACEUTICAL PRODUCT.) | ⤷ Try a Trial |
| Ukraine | 109535 | ГЕТЕРОЦИКЛІЧНІ КАРБОКСАМІДИ, ЯКІ МОДУЛЮЮТЬ АНДРОГЕНОВІ РЕЦЕПТОРИ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЇХ ОСНОВІ ТА СПОСІБ ЛІКУВАННЯ ЗАХВОРЮВАНЬ | ⤷ Try a Trial |
| China | 102596910 | Androgen receptor modulating compounds | ⤷ Try a Trial |
| Ukraine | 90209 | ФУНГИЦИДНАЯ КОМПОЗИЦИЯ, СПОСОБ БОРЬБЫ С ЗАБОЛЕВАНИЯМИ ПОЛЕЗНЫХ РАСТЕНИЙ И СПОСОБ ЗАЩИТЫ ТОВАРОВ;ФУНГІЦИДНА КОМПОЗИЦІЯ, СПОСІБ БОРОТЬБИ ІЗ ЗАХВОРЮВАННЯМИ КОРИСНИХ РОСЛИН ТА СПОСІБ ЗАХИСТУ ТОВАРІВ (FUNGICIDAL COMPOSITION, METHOD FOR CONTROLLING DISEASES OF USEFUL PLANTS AND METHOD FOR PROTECTING GOODS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for darolutamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2493858 | LUC00154 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DAROLUTAMIDE EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1432/001 20200330 |
| 2493858 | PA2020514 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAROLUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327 |
| 2493858 | 122020000030 | Germany | ⤷ Try a Trial | PRODUCT NAME: DAROLUTAMID; NAT. REGISTRATION NO/DATE: EU/1/20/1432 20200327; FIRST REGISTRATION: EU EU/ 1/2011432 20200327 |
| 2493858 | SPC/GB20/022 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/20/1432/001(NI) 20200330; UK PLGB 00010/0677 20200330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
