DrugPatentWatch Database Preview
Apalutamide - Generic Drug Details
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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Apalutamide has two hundred and thirty-three patent family members in forty-two countries.
One supplier is listed for this compound.
Summary for apalutamide
| International Patents: | 233 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 74 |
| Patent Applications: | 1,029 |
| 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 |
Recent Clinical Trials for apalutamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zhujiang Hospital | N/A |
| Coherent Biopharma (Suzhou) Co., Ltd. | Phase 1 |
| U.S. Army Medical Research Acquisition Activity | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for apalutamide
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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 |
|---|---|---|
| China | 111479560 | ⤷ Try it Free |
| Portugal | 3533792 | ⤷ Try it Free |
| Slovenia | 3100727 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for apalutamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | C02368550/01 | Switzerland | ⤷ Try it Free | PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67072 19.09.2019 |
| 2368550 | 122019000060 | Germany | ⤷ Try it Free | PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2368550 | 2019/032 | Ireland | ⤷ Try it Free | PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT AUTHORISATION NO/DATE: EU/1/18/1342 20190114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
