Apalutamide - Generic Drug Details
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What are the generic sources for apalutamide and what is the scope of patent protection?
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-seven patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for apalutamide
International Patents: | 267 |
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 |
---|---|
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 | 60 mg | 210951 | 5 | 2022-02-14 |
US Patents and Regulatory Information for apalutamide
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 |
---|---|---|---|
Canada | 3079135 | ANTI-ANDROGENES DESTINES AU TRAITEMENT DU CANCER DE LA PROSTATE RESISTANT A LA CASTRATION, NON METASTATIQUE (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER) | ⤷ Try a Trial |
Lithuania | 2656841 | ⤷ Try a Trial | |
Croatia | P20210909 | ⤷ Try a Trial | |
European Patent Office | 3777845 | ANTI-ANDROGÈNES POUR LE TRAITEMENT DU CANCER DE LA PROSTATE RÉSISTANT À LA CASTRATION NON MÉTASTATIQUE (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) | ⤷ Try a Trial |
Cyprus | 1124831 | ⤷ Try a Trial | |
Netherlands | 300993 | ⤷ Try a Trial | |
European Patent Office | 2900224 | ANTI-ANDROGÈNES POUR LE TRAITEMENT DU CANCER DE LA PROSTATE NON MÉTASTATIQUE, RÉSISTANT À LA CASTRATION (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) | ⤷ 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 | 2021046 | Norway | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE; NAT. REG. NO/DATE: 18/02193 20190123; FIRST REG. NO/DATE: 1/18/1342 20190116 |
2368550 | 2019C/529 | Belgium | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
2368550 | 2019/032 | Ireland | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
3533792 | 122021000067 | Germany | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
2368550 | 300993 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1342 20190116 |
2368550 | 122019000060 | Germany | ⤷ Try a Trial | PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
2368550 | C 2019 029 | Romania | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |