YONSA Drug Patent Profile
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When do Yonsa patents expire, and when can generic versions of Yonsa launch?
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.
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: | 2,018 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for YONSA
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
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14232508
Estimated Expiration: ⤷ Sign Up
Patent: 15317466
Estimated Expiration: ⤷ Sign Up
Patent: 18241103
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015023629
Estimated Expiration: ⤷ Sign Up
Patent: 2017003219
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 07415
Estimated Expiration: ⤷ Sign Up
Patent: 58316
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15002787
Estimated Expiration: ⤷ Sign Up
China
Patent: 5246598
Estimated Expiration: ⤷ Sign Up
Patent: 6687112
Estimated Expiration: ⤷ Sign Up
Patent: 0604721
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17002472
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1790650
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 69227
Estimated Expiration: ⤷ Sign Up
Patent: 93857
Estimated Expiration: ⤷ Sign Up
Patent: 78266
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 19457
Estimated Expiration: ⤷ Sign Up
Patent: 20162
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1612
Estimated Expiration: ⤷ Sign Up
Patent: 0270
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 20485
Estimated Expiration: ⤷ Sign Up
Patent: 16514707
Estimated Expiration: ⤷ Sign Up
Patent: 17528457
Estimated Expiration: ⤷ Sign Up
Patent: 18135351
Estimated Expiration: ⤷ Sign Up
Patent: 21008521
Estimated Expiration: ⤷ Sign Up
Patent: 23103410
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 15013247
Estimated Expiration: ⤷ Sign Up
Patent: 17003525
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 170048
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 521
Estimated Expiration: ⤷ Sign Up
Patent: 116
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2350
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017500239
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 69227
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 32136
Estimated Expiration: ⤷ Sign Up
Patent: 15144285
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201709400V
Estimated Expiration: ⤷ Sign Up
Patent: 201507681P
Estimated Expiration: ⤷ Sign Up
Patent: 201701139Y
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1507209
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
Estimated Expiration: ⤷ Sign Up
Patent: 170070025
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Patent: 180021932
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Patent: 190141270
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Patent: 230014878
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Spain
Patent: 41800
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 86212
Estimated Expiration: ⤷ Sign Up
Patent: 31321
Estimated Expiration: ⤷ Sign Up
Patent: 1513896
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Patent: 1943408
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Tunisia
Patent: 17000098
Estimated Expiration: ⤷ Sign Up
Patent: 18000318
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 |
---|---|---|---|
Eurasian Patent Organization | 201790650 | ЛЕКАРСТВЕННАЯ ФОРМА И СПОСОБЫ ПРИМЕНЕНИЯ АБИРАТЕРОНА АЦЕТАТА | ⤷ Sign Up |
New Zealand | 712350 | Abiraterone acetate formulation | ⤷ Sign Up |
Brazil | 112015023629 | formulação de acetato de abiraterona | ⤷ Sign Up |
Taiwan | I731321 | ⤷ Sign Up | |
South Korea | 20170070025 | 아비라테론 아세테이트 제제 및 사용 방법 (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE) | ⤷ Sign Up |
Australia | 2018241103 | Abiraterone Acetate Formulation | ⤷ 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 |