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 patent family members in thirty-seven countries.
One supplier is listed for this compound.
Summary for darolutamide
International Patents: | 120 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 35 |
Clinical Trials: | 45 |
Patent Applications: | 384 |
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 |
---|---|
Eli Lilly and Company | Phase 1/Phase 2 |
Bayer | Phase 1/Phase 2 |
Praful Ravi | Phase 1/Phase 2 |
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099-001 | Jul 30, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 risk of developing metastatic disease. |
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 |
---|---|---|---|
Ukraine | 126071 | КРИСТАЛІЧНІ ЧАСТИНКИ N-((S)-1-(3-(3-ХЛОР-4-ЦІАНОФЕНІЛ)-1H-ПІРАЗОЛ-1-ІЛ)-ПРОПАН-2-ІЛ)-5-(1-ГІДРОКСІЕТИЛ)-1H-ПІРАЗОЛ-3-КАРБОКСАМІДУ (MANUFACTURE OF A CRYSTALLINE PHARMACEUTICAL PRODUCT) | See Plans and Pricing |
South Africa | 200806874 | Fungicidal compositions | See Plans and Pricing |
Denmark | 3056485 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for darolutamide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2493858 | 132020000000064 | Italy | See Plans and Pricing | PRODUCT NAME: DAROLUTAMIDE(NUBEQA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1432, 20200330 |
1986495 | SPC/GB18/044 | United Kingdom | See Plans and Pricing | PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND METALAXYL M; REGISTERED: NL NL 15544 N 20171229; UK MAPP NO. 18588 20180619 |
1986495 | 122019000057 | Germany | See Plans and Pricing | PRODUCT NAME: SEDAXANE ODER EIN TAUTOMER HIERVON MIT METALAXYL-M UND MIT FLUDIOXONIL; NAT. REGISTRATION NO/DATE: 008594-00 20181218; FIRST REGISTRATION: NIEDERLANDE 15544 N 20171229 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |