APALUTAMIDE - Generic Drug Details
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What are the generic sources for apalutamide and what is the scope of freedom to operate?
Apalutamide
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Apalutamide has two hundred and sixty-five patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for APALUTAMIDE
International Patents: | 265 |
US Patents: | 10 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 109 |
Patent Applications: | 1,411 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for APALUTAMIDE
Generic Entry Date for APALUTAMIDE*:
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 APALUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme LLC | Phase 2 |
Prostate Cancer Foundation | Phase 2 |
University of Cincinnati | Phase 2 |
Paragraph IV (Patent) Challenges for APALUTAMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 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 |
---|---|---|---|
Japan | 2016011315 | 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 a Trial |
Slovenia | 3100727 | ⤷ Try a Trial | |
Jordan | P20200076 | مضادات أندروجين لعلاج سرطان البروستاتا غير النقيلي المقاوم للاستئصال (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER) | ⤷ Try a Trial |
Eurasian Patent Organization | 028791 | КРИСТАЛЛИЧЕСКАЯ ФОРМА МОДУЛЯТОРА АНДРОГЕННЫХ РЕЦЕПТОРОВ (CRYSTALLINE FORM OF AN ANDROGEN RECEPTOR MODULATOR) | ⤷ Try a Trial |
Mexico | 2014015005 | FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO. (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR.) | ⤷ Try a Trial |
Norway | 2021046 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APALUTAMIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3533792 | 122021000067 | Germany | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
2368550 | CR 2019 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116 |
2368550 | C02368550/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67072 19.09.2019 |
2368550 | 1990032-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116 |
2368550 | PA2019512 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
2368550 | 122019000060 | Germany | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |