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ZYTIGA Drug Profile
Which patents cover Zytiga, and when can generic versions of Zytiga launch?
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-four patent family members in eighteen countries.
The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for ZYTIGA
| International Patents: | 34 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 75 |
| Patent Applications: | 64 |
| 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 |
|---|---|
| Children's Hospital Los Angeles | Phase 2 |
| University of Michigan | Phase 2 |
| Feinstein Institute for Medical Research | Phase 2 |
Recent Litigation for ZYTIGA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BTG INTERNATIONAL LIMITED v. QILU PHARMACEUTICAL CO., LTD. | 2018-11-28 |
| BTG INTERNATIONAL LIMITED v. MSN PHARMACEUTICALS INC. | 2018-02-20 |
| BTG INTERNATIONAL LIMITED v. AMERIGEN PHARMACEUTICALS, INC. | 2016-05-02 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| ACTAVIS LABORATORIES FL, INC. | 2017-02-08 |
| Wockhardt Bio AG | 2016-08-10 |
| Mylan Pharmaceuticals Inc. | 2016-06-30 |
Pharmacology for ZYTIGA
| Drug Class | Cytochrome P450 17A1 Inhibitor |
| Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors |
Synonyms for ZYTIGA
| (1S,2R,5S,10R,11S,15S)-2,15-dimethyl-14-(pyridin-3-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-7,13-dien-5-yl acetate |
| (3?)-17-(3-Pyridinyl)androsta-5,16-dien-3-yl acetate |
| (3beta)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol acetate (ester) |
| (3beta)-17-(pyridin-3-yl)androsta-5,16-dien-3-yl acetate |
| (3S,8R,9S,10R,13S,14S)-10,13-DIMETHYL-17-(PYRIDIN-3-YL)-2,3,4,7,8,9,10,11,12,13,14,15-DODECAHYDRO-1H-CYCLOPENTA[A]PHENANTHREN-3-YL ACETATE |
| [(3S,10R,13S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate |
| [(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate |
| [(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] ethanoate |
| 154229-18-2 |
| 17-(3-Pyridyl)-5,16-androstadien-3-b-acetate |
| 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate |
| 17-(3-Pyridyl)androsta-5, acetate |
| 17-(pyridin-3-yl)androsta-5,16-dien-3beta-yl acetate |
| 3|A-acetoxy-17-(3-pyridyl)androsta-5,16-diene |
| 3b-acetoxy-17-(3-pyridyl)androsta-5,16-diene |
| 3beta-17-(3-Pyridyl)androsta-5,16-dien-3-ol Acetate |
| 3beta-Acetoxy-17-(3-pyridyl)androsta-5,16-diene |
| 3S,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-ol, 3-acetate |
| A809510 |
| AB0032741 |
| AB07697 |
| Abiraterone Acetate |
| Abiraterone Acotate |
| Abiraterone (acetate) |
| Abiraterone acetate |
| Abiraterone Acetate (CB7630) |
| Abiraterone acetate (JAN/USAN) |
| Abiraterone acetate [USAN] |
| Abiraterone acetate, >=98% (HPLC) |
| Abiraterone acetate, United States Pharmacopeia (USP) Reference Standard |
| Abiraterone acetate/CB 7630 |
| ABP001055 |
| AC-25760 |
| acetic acid [(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-(3-pyridinyl)-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] ester |
| ACN-031820 |
| AJ-45666 |
| AKOS015896502 |
| AMX10148 |
| Androsta-5, 17-(3-pyridinyl)-, 3-acetate, |
| Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, acetate (ester), (3beta)- |
| BC657179 |
| BCP02949 |
| BDBM50407398 |
| BRD-K24048528-001-02-5 |
| CAS-154229-18-2 |
| CB 7630 |
| CB 7630; JNJ 212082 |
| CB-7630 |
| CB7630 |
| CHEBI:68639 |
| CHEMBL271227 |
| CS-0544 |
| CTK8E7107 |
| D09701 |
| DS-2007 |
| DSSTox_CID_28969 |
| DSSTox_GSID_49043 |
| DSSTox_RID_83234 |
| DTXSID3049043 |
| EBD32544 |
| EM5OCB9YJ6 |
| EX-A107 |
| GTPL9288 |
| HY-75054 |
| I06-2461 |
| JNJ-2012082 |
| MFCD00934213 |
| MLS006010090 |
| MolPort-006-391-496 |
| NCGC00186462-01 |
| NSC-748121 |
| NSC-749227 |
| NSC748121 |
| NSC749227 |
| RT-011150 |
| S-7704 |
| s2246 |
| SC-66343 |
| SCHEMBL93715 |
| SMR004701235 |
| ST24024598 |
| Tox21_113589 |
| UNII-EM5OCB9YJ6 |
| UVIQSJCZCSLXRZ-UBUQANBQSA-N |
| W-201385 |
| X6144 |
| Yonsa |
| ZINC3809191 |
| Zytiga (TN) |
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 |
|---|---|---|
| Canada | 2661422 | Start Trial |
| Australia | 2018271331 | Start Trial |
| Spain | 2428634 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYTIGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0633893 | SPC/GB11/063 | United Kingdom | Start Trial | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 |
| 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 |
| 0633893 | 11C0055 | France | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
