DrugPatentWatch Database Preview
Apalutamide - Generic Drug Details
» See Plans and Pricing
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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Apalutamide has one hundred and seventy-four patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for apalutamide
| International Patents: | 174 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 63 |
| Patent Applications: | 532 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for apalutamide |
| DailyMed Link: | apalutamide at DailyMed |
Recent Clinical Trials for apalutamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen-Cilag Ltd. | Phase 3 |
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| Zenith Epigenetics | Phase 2 |
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 | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for apalutamide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6422519 | Start Trial |
| European Patent Office | 3348553 | Start Trial |
| Cyprus | 1117958 | Start Trial |
| Hong Kong | 1163495 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for apalutamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | CR 2019 00029 | Denmark | Start Trial | PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116 |
| 2368550 | CA 2019 00029 | Denmark | Start Trial | PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116 |
| 2368550 | 2019C/529 | Belgium | Start Trial | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| 2368550 | 132019000000084 | Italy | Start Trial | PRODUCT NAME: APALUTAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
