Darolutamide - Generic Drug Details
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What are the generic 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-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 |
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 | ⤷ Sign Up | |||
| 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 | ⤷ 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 | Y | ⤷ Sign Up | |||
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2018162793 | ⤷ Sign Up | |
| Australia | 2007213960 | Fungicidal compositions | ⤷ Sign Up |
| Japan | 2018503662 | 安定結晶形のカルボキサミド誘導体およびそのジアステレオマー | ⤷ Sign Up |
| Slovenia | 3056485 | ⤷ Sign Up | |
| Israel | 238044 | 2-כלורו-4-(h1-פיראזול-5-איל)בנזוניטריל ו-(s)-4-(1-(2-אמינופרופיל)-h1-פיראזול-3-איל)-2-כלורו- בנזוניטריל כחומרי ביניים בתהליך להכנת (s)-3-אצטיל-n-1-(3-(3-כלורו-4-ציאנופניל)-1h-פיראזול-1-יל)פרופאנ-2-איל)- 1h-פיראזול-5-קרבוקסאמיד (2-chloro-4-(1h-pyrazol-5-yl)benzonitrile and (s)-4-(1-(2-aminopropyl)-1h-pyrazol-3-yl)-2-chlorobenzonitrile as intermediates in the process for preparing (s)-3-acetyl-n-(1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)propan-2-yl)-1h-pyrazole-5-carboxamide) | ⤷ Sign Up |
| Denmark | 3369732 | ⤷ 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 | LUC00154 | Luxembourg | ⤷ Sign Up | 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 |
| 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 | 2020C/514 | Belgium | ⤷ Sign Up | PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330 |
| 2493858 | SPC/GB20/022 | United Kingdom | ⤷ Sign Up | 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 |
| 2493858 | 2090018-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1432/001 20200330 |
| 1986495 | SPC/GB18/044 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND METALAXYL M; REGISTERED: NL NL 15544 N 20171229; UK MAPP NO. 18588 20180619 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
