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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Apalutamide has two hundred and eighty-seven patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for APALUTAMIDE
| International Patents: | 287 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 111 |
| 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
*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 |
| University of Cincinnati | 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
| 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 | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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 |
|---|---|---|---|
| Slovenia | 3412290 | ⤷ Sign Up | |
| Canada | 3079135 | ⤷ Sign Up | |
| Finland | 2004181 | ⤷ Sign Up | |
| Japan | 2019081815 | 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) | ⤷ Sign Up |
| Hungary | E054595 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APALUTAMIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | PA2019512,C2368550 | Lithuania | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 3533792 | 2021046 | Norway | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDE; NAT. REG. NO/DATE: 18/02193 20190123; FIRST REG. NO/DATE: 1/18/1342 20190116 |
| 3533792 | 301144 | Netherlands | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDE; REGISTRATION NO/DATE: EU/1/18/1342 20190116 |
| 3533792 | PA2021525 | Lithuania | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDAS; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2368550 | 122019000060 | Germany | ⤷ Sign Up | 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 |
