YONSA Drug Patent Profile
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Which patents cover Yonsa, and what generic alternatives are available?
Yonsa is a drug marketed by Sun Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-eight patent family members in twenty-six countries.
The generic ingredient in YONSA 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 Yonsa
A generic version of YONSA was approved as abiraterone acetate by APOTEX on October 31st, 2018.
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Summary for YONSA
| International Patents: | 58 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Patent Applications: | 1,604 |
| Drug Prices: | Drug price information for YONSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for YONSA |
| What excipients (inactive ingredients) are in YONSA? | YONSA excipients list |
| DailyMed Link: | YONSA at DailyMed |
Pharmacology for YONSA
| 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 YONSA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| YONSA | Tablets | abiraterone acetate | 125 mg | 210308 | 1 | 2018-07-23 |
US Patents and Regulatory Information for YONSA
YONSA is protected by two US patents.
Patents protecting YONSA
Abiraterone steroid formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER
Abiraterone acetate formulation and methods of use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | YONSA | abiraterone acetate | TABLET;ORAL | 210308-001 | May 22, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | YONSA | abiraterone acetate | TABLET;ORAL | 210308-001 | May 22, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for YONSA
| 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 YONSA
When does loss-of-exclusivity occur for YONSA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5480
Patent: FORMULACIÓN DE ACETATO DE ABIRATERONA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14232508
Patent: Abiraterone acetate formulation
Estimated Expiration: ⤷ Sign Up
Patent: 15317466
Patent: Abiraterone acetate formulation and methods of use
Estimated Expiration: ⤷ Sign Up
Patent: 18241103
Patent: Abiraterone Acetate Formulation
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015023629
Patent: formulação de acetato de abiraterona
Estimated Expiration: ⤷ Sign Up
Patent: 2017003219
Patent: formulação de acetato de abiraterona e métodos de uso
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 07415
Patent: FORMULATION D'ACETATE D'ABIRATERONE (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 58316
Patent: FORMULATION D'ACETATE D'ABIRATERONE ET SES PROCEDES D'UTILISATION (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15002787
Patent: Formulación de acetato de abiraterona.
Estimated Expiration: ⤷ Sign Up
China
Patent: 5246598
Patent: Abiraterone acetate formulation
Estimated Expiration: ⤷ Sign Up
Patent: 6687112
Patent: 醋酸阿比特龙制剂和使用方法 (Abiraterone acetate formulation and methods of use)
Estimated Expiration: ⤷ Sign Up
Patent: 0604721
Patent: 乙酸阿比特龙酯制剂 (Abiraterone acetate preparation)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17002472
Patent: Formulación de acetato de abiraterona
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1790650
Patent: ЛЕКАРСТВЕННАЯ ФОРМА И СПОСОБЫ ПРИМЕНЕНИЯ АБИРАТЕРОНА АЦЕТАТА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 69227
Patent: FORMULATION D'ACÉTATE D'ABIRATÉRONE (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 93857
Patent: FORMULATION D'ACÉTATE D'ABIRATÉRONE ET SES PROCÉDÉS D'UTILISATION (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
Estimated Expiration: ⤷ Sign Up
Patent: 78266
Patent: FORMULATION D'ACÉTATE D'ABIRATÉRONE (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 19457
Patent: 乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 20162
Patent: 乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1612
Patent: פורמולציה של אבירטרון אצטאט (Abiraterone acetate formulation)
Estimated Expiration: ⤷ Sign Up
Patent: 0270
Patent: פורמולציות אבירטרון אצטט ושיטות שימוש (Abiraterone acetate formulation and methods of use)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 20485
Estimated Expiration: ⤷ Sign Up
Patent: 16514707
Patent: アビラテロン酢酸エステル製剤
Estimated Expiration: ⤷ Sign Up
Patent: 17528457
Patent: 酢酸アビラテロン製剤及び使用方法
Estimated Expiration: ⤷ Sign Up
Patent: 18135351
Patent: アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 21008521
Patent: アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 23103410
Patent: アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 15013247
Patent: FORMULACION DE ACETATO DE ABIRATERONA. (ABIRATERONE ACETATE FORMULATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 17003525
Patent: FORMULACION DE ACETATO DE ABIRATERONA Y METODOS DE USO. (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE.)
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 170048
Patent: Formulare pe bază de acetat de abirateronă şi procedee de utilizare a acesteia (Abiraterone acetate formulation and methods of use)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 521
Patent: Formulation d'acétate d'abiratérone utilisé dans le traitement du cancer de la prostate resistant a la castration
Estimated Expiration: ⤷ Sign Up
Patent: 116
Patent: Formulation d'acétate d'abiratérone et ses procédés d'utilisation
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2350
Patent: Abiraterone acetate formulation
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017500239
Patent: ABIRATERONE ACETATE FORMULATION AND METHODS OF USE
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 69227
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 32136
Patent: СОСТАВ НА ОСНОВЕ АБИРАТЕРОНА АЦЕТАТА (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 15144285
Patent: СОСТАВ НА ОСНОВЕ АБИРАТЕРОНА АЦЕТАТА
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201709400V
Patent: ABIRATERONE ACETATE FORMULATION
Estimated Expiration: ⤷ Sign Up
Patent: 201507681P
Patent: ABIRATERONE ACETATE FORMULATION
Estimated Expiration: ⤷ Sign Up
Patent: 201701139Y
Patent: ABIRATERONE ACETATE FORMULATION AND METHODS OF USE
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1507209
Patent: ABIRATERONE ACETATE FORMULATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2121404
Estimated Expiration: ⤷ Sign Up
Patent: 2491439
Estimated Expiration: ⤷ Sign Up
Patent: 2617537
Estimated Expiration: ⤷ Sign Up
Patent: 160023641
Patent: 아비라테론 아세테이트 제제 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 170070025
Patent: 아비라테론 아세테이트 제제 및 사용 방법 (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
Estimated Expiration: ⤷ Sign Up
Patent: 180021932
Patent: 아비라테론 아세테이트 제제 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 190141270
Patent: 아비라테론 아세테이트 제제 (ABIRATERONE ACETATE FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 230014878
Patent: 아비라테론 아세테이트 제제 및 사용 방법 (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 41800
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 86212
Estimated Expiration: ⤷ Sign Up
Patent: 31321
Estimated Expiration: ⤷ Sign Up
Patent: 1513896
Patent: Abiraterone acetate formulation
Estimated Expiration: ⤷ Sign Up
Patent: 1943408
Patent: Abiraterone acetate formulation
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 17000098
Patent: ABIRATERONE ACETATE FORMULATION AND METHODS OF USE.
Estimated Expiration: ⤷ Sign Up
Patent: 18000318
Patent: ABIRATERONE ACETATE FORMULATION AND METHODS OF USE.
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering YONSA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112017003219 | formulação de acetato de abiraterona e métodos de uso | ⤷ Sign Up |
| South Korea | 20160023641 | 아비라테론 아세테이트 제제 (ABIRATERONE ACETATE FORMULATION) | ⤷ Sign Up |
| South Korea | 102617537 | ⤷ Sign Up | |
| New Zealand | 712350 | Abiraterone acetate formulation | ⤷ Sign Up |
| Morocco | 38521 | Formulation d'acétate d'abiratérone utilisé dans le traitement du cancer de la prostate resistant a la castration | ⤷ Sign Up |
| Taiwan | I686212 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for YONSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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