DrugPatentWatch Database Preview
ZYTIGA Drug Patent Profile
Email this page to a colleague
Which patents cover Zytiga, and what generic alternatives are available?
Zytiga is a drug marketed by Janssen Biotech and is included in one NDA.
The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zytiga
A generic version of ZYTIGA was approved as abiraterone acetate by APOTEX on October 31st, 2018.
Summary for ZYTIGA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Clinical Trials: | 104 |
| Patent Applications: | 2,265 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZYTIGA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZYTIGA |
| What excipients (inactive ingredients) are in ZYTIGA? | ZYTIGA excipients list |
| DailyMed Link: | ZYTIGA at DailyMed |
Recent Clinical Trials for ZYTIGA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Texas Southwestern Medical Center | Phase 2 |
| Feinstein Institute for Medical Research | Phase 2 |
| University of Michigan | Phase 2 |
Pharmacology for ZYTIGA
| Drug Class | Cytochrome P450 17A1 Inhibitor |
| Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZYTIGA
Paragraph IV (Patent) Challenges for ZYTIGA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZYTIGA | TABLET;ORAL | abiraterone acetate | 202379 | 2017-08-23 |
| ZYTIGA | TABLET;ORAL | abiraterone acetate | 202379 | 2015-04-28 |
US Patents and Regulatory Information for ZYTIGA
ZYTIGA is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting ZYTIGA
ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | AB | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | AB | 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 |
Expired US Patents for ZYTIGA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZYTIGA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20130961 | ⤷ Try it Free |
| Australia | 2017201764 | ⤷ Try it Free |
| European Patent Office | 0721461 | ⤷ Try it Free |
| United Kingdom | 9419139 | ⤷ Try it Free |
| United Kingdom | 2265624 | ⤷ Try it Free |
| Japan | H07505377 | ⤷ Try it Free |
| Germany | 122012000012 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYTIGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0633893 | 1190040-4 | Sweden | ⤷ Try it Free | PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905 |
| 0633893 | CA 2011 00035 | Denmark | ⤷ Try it Free | |
| 0633893 | 11C0055 | France | ⤷ Try it Free | PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905 |
| 0633893 | C00633893/01 | Switzerland | ⤷ Try it Free | PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011 |
| 0633893 | 2012/003 | Ireland | ⤷ Try it Free | PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905 |
| 0633893 | C300508 | Netherlands | ⤷ Try it Free | PRODUCT NAME: ABIRATERON ALSMEDE ZUURADDITIEZOUTEN EN 3-ESTERS ERVAN, IN HET BIJZONDER ABIRATERONACETAAT; NAT. REGISTRATION NO/DATE: EU/1/11/714/001 20110905; FIRST REGISTRATION: |
| 0633893 | 91911 | Luxembourg | ⤷ Try it Free | 91911, EXPIRES: 20180315 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
