ZYTIGA Drug Patent 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.
The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-six 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.
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Summary for ZYTIGA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 115 |
Patent Applications: | 1,604 |
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 |
---|---|
Merck Sharp & Dohme LLC | Phase 3 |
Orion Corporation, Orion Pharma | Phase 3 |
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Phase 2/Phase 3 |
Pharmacology for ZYTIGA
Drug Class | Cytochrome P450 17A1 Inhibitor |
Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors |
Paragraph IV (Patent) Challenges for ZYTIGA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZYTIGA | Tablets | abiraterone acetate | 500 mg | 202379 | 1 | 2017-08-23 |
ZYTIGA | Tablets | abiraterone acetate | 250 mg | 202379 | 13 | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ZYTIGA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Mylan Ireland Limited | Abiraterone Mylan | abiraterone acetate | EMEA/H/C/005368 Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. |
Authorised | yes | no | no | 2021-08-20 | |
Krka, d.d., Novo mesto | Abiraterone Krka | abiraterone acetate | EMEA/H/C/005649 Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. |
Authorised | yes | no | no | 2021-06-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZYTIGA
See the table below for patents covering ZYTIGA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2428634 | ⤷ Sign Up | |
Japan | H09502994 | ⤷ Sign Up | |
Japan | 2021038252 | 癌を治療するための方法及び組成物 (METHOD AND COMPOSITION FOR TREATING CANCER) | ⤷ Sign Up |
Japan | H07505377 | ⤷ Sign Up | |
Canada | 2170286 | SYNTHESE DE STEROIDES A BASE DE 17-(3-PYRIDYL) (SYNTHESIS OF 17-(3-PYRIDYL) STEROIDS) | ⤷ Sign Up |
New Zealand | 273367 | PREPARATION OF 3 |
⤷ Sign Up |
Cyprus | 1115477 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYTIGA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0633893 | 11C0055 | France | ⤷ Sign Up | 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 | 2012/003 | Ireland | ⤷ Sign Up | 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 | CA 2011 00035 | Denmark | ⤷ Sign Up | |
0633893 | 91911 | Luxembourg | ⤷ Sign Up | 91911, EXPIRES: 20180315 |
0633893 | 1190040-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905 |
0633893 | C300508 | Netherlands | ⤷ Sign Up | 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 | SPC/GB11/063 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |