Apalutamide - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for apalutamide and what is the scope of patent protection?
Apalutamide
is the generic ingredient in two branded drugs marketed by Zydus and Janssen Biotech, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Apalutamide has two hundred and ninety-four patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for apalutamide
International Patents: | 294 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 111 |
Patent Applications: | 2,814 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for apalutamide |
What excipients (inactive ingredients) are in apalutamide? | apalutamide excipients list |
DailyMed Link: | apalutamide at DailyMed |
Recent Clinical Trials for apalutamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Prostate Cancer Foundation | Phase 2 |
Merck Sharp & Dohme LLC | Phase 2 |
Xian-Janssen Pharmaceutical Ltd. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for apalutamide
Paragraph IV (Patent) Challenges for APALUTAMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ERLEADA | Tablets | apalutamide | 240 mg | 210951 | 1 | 2025-03-20 |
ERLEADA | Tablets | apalutamide | 60 mg | 210951 | 5 | 2022-02-14 |
US Patents and Regulatory Information for apalutamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | 9,987,261 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | 9,481,663 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | 11,963,952 | ⤷ Try for Free | ⤷ Try for Free | ||||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | AB | RX | Yes | No | 10,702,508 | ⤷ Try for Free | ⤷ Try for Free | |||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | AB | RX | Yes | No | 8,802,689 | ⤷ Try for Free | ⤷ Try for Free | |||
Zydus | APALUTAMIDE | apalutamide | TABLET;ORAL | 217113-001 | Mar 17, 2025 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 apalutamide
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Janssen-Cilag International NV | Erleada | apalutamide | EMEA/H/C/004452 Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). |
Authorised | no | no | no | 2019-01-14 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for apalutamide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20150765 | ANTIANDROGENOS PARA EL TRATAMIENTO DEL CANCER DE PROSTATA RESISTENTE A LA CASTRACION NO METASTASICO | ⤷ Try for Free |
South Korea | 20210013342 | 비전이성 거세 저항성 전립선암 치료용 항안드로겐 (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) | ⤷ Try for Free |
Hong Kong | 1252867 | 用於治療非轉移性去勢抵抗性前列腺癌的抗雄激素 (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) | ⤷ Try for Free |
Denmark | 2858985 | ⤷ Try for Free | |
Japan | 2017105845 | 前立腺癌およびアンドロゲン受容体関連病態の治療のためのアンドロゲン受容体の調節剤 (ANDROGEN RECEPTOR MODULATOR FOR TREATMENT OF PROSTATE CANCER AND ANDROGEN RECEPTOR-ASSOCIATED DISEASES) | ⤷ Try for Free |
Peru | 20150631 | FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for apalutamide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2368550 | 765 | Finland | ⤷ Try for Free | |
3533792 | 2021046 | Norway | ⤷ Try for Free | PRODUCT NAME: APALUTAMIDE; NAT. REG. NO/DATE: 18/02193 20190123; FIRST REG. NO/DATE: 1/18/1342 20190116 |
2368550 | C 2019 029 | Romania | ⤷ Try for Free | PRODUCT NAME: APALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF NATIONAL AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114 |
3533792 | C202130058 | Spain | ⤷ Try for Free | PRODUCT NAME: APALUTAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114 |
2368550 | PA2019512,C2368550 | Lithuania | ⤷ Try for Free | PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
2368550 | 2019C/529 | Belgium | ⤷ Try for Free | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Apalutamide
More… ↓