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ZYTIGA Drug Profile
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Which patents cover Zytiga, and what generic alternatives are available?
Zytiga is a drug marketed by Janssen Biotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has thirty-eight patent family members in nineteen countries.
The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
US ANDA 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
| International Patents: | 38 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 86 |
| Patent Applications: | 66 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZYTIGA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZYTIGA |
| DailyMed Link: | ZYTIGA at DailyMed |
Recent Clinical Trials for ZYTIGA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Celgene | Phase 1 |
| Myovant Sciences GmbH | Phase 1 |
| Bayer | Phase 4 |
Pharmacology for ZYTIGA
| Drug Class | Cytochrome P450 17A1 Inhibitor |
| Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors |
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
| 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 | Start Trial | Start Trial | Start Trial | |||
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZYTIGA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 197211 | Start Trial |
| United Kingdom | 9414192 | Start Trial |
| Israel | 257681 | Start Trial |
| Croatia | P20130961 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYTIGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0633893 | 91911 | Luxembourg | Start Trial | 91911, EXPIRES: 20180315 |
| 0633893 | 1190040-4 | Sweden | Start Trial | PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905 |
| 0633893 | C300508 | Netherlands | Start Trial | 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 | 2012/003 | Ireland | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
