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Last Updated: October 1, 2022

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-three 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. Eighteen 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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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER

Abiraterone acetate formulation and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm YONSA abiraterone acetate TABLET;ORAL 210308-001 May 22, 2018 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 14232508
Estimated Expiration: See Plans and Pricing

Patent: 15317466
Estimated Expiration: See Plans and Pricing

Patent: 18241103
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015023629
Estimated Expiration: See Plans and Pricing

Patent: 2017003219
Estimated Expiration: See Plans and Pricing

Canada

Patent: 07415
Estimated Expiration: See Plans and Pricing

Patent: 58316
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15002787
Estimated Expiration: See Plans and Pricing

China

Patent: 5246598
Estimated Expiration: See Plans and Pricing

Patent: 6687112
Estimated Expiration: See Plans and Pricing

Patent: 0604721
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17002472
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1790650
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69227
Estimated Expiration: See Plans and Pricing

Patent: 93857
Estimated Expiration: See Plans and Pricing

Patent: 78266
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 19457
Estimated Expiration: See Plans and Pricing

Patent: 20162
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1612
Estimated Expiration: See Plans and Pricing

Patent: 0270
Estimated Expiration: See Plans and Pricing

Japan

Patent: 16514707
Estimated Expiration: See Plans and Pricing

Patent: 17528457
Estimated Expiration: See Plans and Pricing

Patent: 18135351
Estimated Expiration: See Plans and Pricing

Patent: 21008521
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15013247
Estimated Expiration: See Plans and Pricing

Patent: 17003525
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 170048
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 521
Estimated Expiration: See Plans and Pricing

Patent: 116
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2350
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017500239
Estimated Expiration: See Plans and Pricing

Poland

Patent: 69227
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 32136
Estimated Expiration: See Plans and Pricing

Patent: 15144285
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201709400V
Estimated Expiration: See Plans and Pricing

Patent: 201507681P
Estimated Expiration: See Plans and Pricing

Patent: 201701139Y
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1507209
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2121404
Estimated Expiration: See Plans and Pricing

Patent: 160023641
Estimated Expiration: See Plans and Pricing

Patent: 170070025
Estimated Expiration: See Plans and Pricing

Patent: 180021932
Estimated Expiration: See Plans and Pricing

Patent: 190141270
Estimated Expiration: See Plans and Pricing

Spain

Patent: 41800
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 86212
Estimated Expiration: See Plans and Pricing

Patent: 31321
Estimated Expiration: See Plans and Pricing

Patent: 1513896
Estimated Expiration: See Plans and Pricing

Patent: 1943408
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000098
Estimated Expiration: See Plans and Pricing

Patent: 18000318
Estimated Expiration: See Plans and Pricing

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
Australia 2014232508 Abiraterone acetate formulation See Plans and Pricing
Japan 2017528457 酢酸アビラテロン製剤及び使用方法 See Plans and Pricing
Brazil 112015023629 formulação de acetato de abiraterona See Plans and Pricing
Canada 2958316 FORMULATION D'ACETATE D'ABIRATERONE ET SES PROCEDES D'UTILISATION (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE) See Plans and Pricing
Russian Federation 2015144285 СОСТАВ НА ОСНОВЕ АБИРАТЕРОНА АЦЕТАТА See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
0633893 11C0055 France See Plans and Pricing 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 See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

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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.