YONSA Drug Patent Profile
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Which patents cover Yonsa, 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER
Abiraterone acetate formulation and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm | YONSA | abiraterone acetate | TABLET;ORAL | 210308-001 | May 22, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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: ⤷ Try a Trial
Australia
Patent: 14232508
Estimated Expiration: ⤷ Try a Trial
Patent: 15317466
Estimated Expiration: ⤷ Try a Trial
Patent: 18241103
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015023629
Estimated Expiration: ⤷ Try a Trial
Patent: 2017003219
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 07415
Estimated Expiration: ⤷ Try a Trial
Patent: 58316
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 15002787
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5246598
Estimated Expiration: ⤷ Try a Trial
Patent: 6687112
Estimated Expiration: ⤷ Try a Trial
Patent: 0604721
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17002472
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1790650
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 69227
Estimated Expiration: ⤷ Try a Trial
Patent: 93857
Estimated Expiration: ⤷ Try a Trial
Patent: 78266
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 19457
Estimated Expiration: ⤷ Try a Trial
Patent: 20162
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1612
Estimated Expiration: ⤷ Try a Trial
Patent: 0270
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 20485
Estimated Expiration: ⤷ Try a Trial
Patent: 16514707
Estimated Expiration: ⤷ Try a Trial
Patent: 17528457
Estimated Expiration: ⤷ Try a Trial
Patent: 18135351
Estimated Expiration: ⤷ Try a Trial
Patent: 21008521
Estimated Expiration: ⤷ Try a Trial
Patent: 23103410
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 15013247
Estimated Expiration: ⤷ Try a Trial
Patent: 17003525
Estimated Expiration: ⤷ Try a Trial
Moldova, Republic of
Patent: 170048
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 521
Estimated Expiration: ⤷ Try a Trial
Patent: 116
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2350
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017500239
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 69227
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 32136
Estimated Expiration: ⤷ Try a Trial
Patent: 15144285
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201709400V
Estimated Expiration: ⤷ Try a Trial
Patent: 201507681P
Estimated Expiration: ⤷ Try a Trial
Patent: 201701139Y
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1507209
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2121404
Estimated Expiration: ⤷ Try a Trial
Patent: 2491439
Estimated Expiration: ⤷ Try a Trial
Patent: 2617537
Estimated Expiration: ⤷ Try a Trial
Patent: 160023641
Estimated Expiration: ⤷ Try a Trial
Patent: 170070025
Estimated Expiration: ⤷ Try a Trial
Patent: 180021932
Estimated Expiration: ⤷ Try a Trial
Patent: 190141270
Estimated Expiration: ⤷ Try a Trial
Patent: 230014878
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 41800
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 86212
Estimated Expiration: ⤷ Try a Trial
Patent: 31321
Estimated Expiration: ⤷ Try a Trial
Patent: 1513896
Estimated Expiration: ⤷ Try a Trial
Patent: 1943408
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 17000098
Estimated Expiration: ⤷ Try a Trial
Patent: 18000318
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Moldova, Republic of | 20170048 | Formulare pe bază de acetat de abirateronă şi procedee de utilizare a acesteia (Abiraterone acetate formulation and methods of use) | ⤷ Try a Trial |
Hong Kong | 1220162 | 乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION) | ⤷ Try a Trial |
Singapore | 11201701139Y | ABIRATERONE ACETATE FORMULATION AND METHODS OF USE | ⤷ Try a Trial |
Colombia | 2017002472 | Formulación de acetato de abiraterona | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for YONSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0633893 | 11C0055 | France | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | SPC/GB11/063 | United Kingdom | ⤷ Try a Trial | 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 |