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Generated: October 23, 2017
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 are two patents protecting this drug and two Paragraph IV challenges.| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 48 |
| Clinical Trials: see list | 63 |
| Patent Applications: see list | 49 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ZYTIGA at DailyMed |
| Drug Class | Cytochrome P450 17A1 Inhibitor |
| Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors |
| 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 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| abiraterone acetate | Tablets | 500 mg | Zytiga | 8/23/2017 |
| abiraterone acetate | Tablets | 250 mg | Zytiga | 4/28/2015 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,618,807 | Method for preparing 17-substituted steroids useful in cancer treatment | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Greece | 3029601 | ► Subscribe | |||||||||||||
| European Patent Office | 0721461 | ► Subscribe | |||||||||||||
| Spain | 2138618 | ► Subscribe | |||||||||||||
| Canada | 2132449 | ► Subscribe | |||||||||||||
| New Zealand | 597830 | ► Subscribe | |||||||||||||
| Australia | 3758493 | ► Subscribe | |||||||||||||
| Hong Kong | 1131577 | ► Subscribe | |||||||||||||
| Japan | 2012082215 | ► Subscribe | |||||||||||||
| Croatia | P20130961 | ► Subscribe | |||||||||||||
| Hong Kong | 1002634 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB11/063 | United Kingdom | ► Subscribe | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 | ||||||||||||
| 911 | Luxembourg | ► Subscribe | 91911, EXPIRES: 20180315 | ||||||||||||
| 12/003 | Ireland | ► Subscribe | 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 | ||||||||||||
| 0633893/01 | Switzerland | ► Subscribe | PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011 | ||||||||||||
| 90040-4 | Sweden | ► Subscribe | PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905 | ||||||||||||
| 2011 00035 | Denmark | ► Subscribe | |||||||||||||
| C0055 | France | ► Subscribe | 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 | ||||||||||||
| 00508 | Netherlands | ► Subscribe | 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: | ||||||||||||
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Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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