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 | 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 | 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 |
---|---|---|---|
Spain | 2486263 | ⤷ Sign Up | |
European Patent Office | 2754656 | Composés de modulation du récepteur d'androgènes (Androgen receptor modulating compounds) | ⤷ Sign Up |
South Korea | 20190126111 | 결정성 의약품의 제조 | ⤷ 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 | 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 | 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 |
2493858 | CA 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 |