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-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 | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ 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 | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
|---|---|---|---|
| Lithuania | 2656842 | ⤷ Try a Trial | |
| Japan | 6527621 | ⤷ Try a Trial | |
| Denmark | 3100727 | ⤷ Try a Trial | |
| Japan | 2020193234 | 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APALUTAMIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3533792 | 2021C/545 | Belgium | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| 3533792 | PA2021525 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDAS; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2368550 | C20190027 00294 | Estonia | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIID;REG NO/DATE: EU/1/18/1342 16.01.2019 |
| 2368550 | LUC00123 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
