YONSA Drug Patent Profile

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 sixty 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-three 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 31^st, 2018.

Summary for YONSA

International Patents:	60
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Patent Applications:	1,611
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

See drug prices for YONSA

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.

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	10,292,990
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	9,889,144		Y

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Moldova, Republic of

Morocco

New Zealand

Philippines

Poland

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

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
Canada	2907415
Chile	2015002787
Chile	2015002787	Formulación de acetato de abiraterona.
European Patent Office	3578266
Hong Kong	1220162	乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION)
Israel	241612
Mexico	2017003525	FORMULACION DE ACETATO DE ABIRATERONA Y METODOS DE USO. (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE.)

Supplementary Protection Certificates for YONSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	11C0055	France		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		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		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905

Market Dynamics and Financial Trajectory for YONSA

Introduction to YONSA

YONSA, developed by Churchill Pharmaceuticals and marketed by Sun Pharma, is a significant player in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The drug contains the active ingredient abiraterone acetate and is formulated to be used in combination with methylprednisolone.

FDA Approval and Market Entry

In May 2018, Sun Pharma received FDA approval for YONSA, marking a crucial milestone in its market entry. This approval was facilitated by a licensing deal between Sun Pharma and Churchill Pharmaceuticals, the original developer of the drug[1].

Competitive Landscape

YONSA enters a market dominated by Johnson & Johnson's Zytiga, another abiraterone acetate-based drug. However, YONSA's formulation avoids patent issues associated with Zytiga, making it a viable competitor. The patent invalidation of Zytiga's administration method by the Patent Trial and Appeal Board further opened the door for generic and alternative competition[1].

Clinical Efficacy and Formulation

YONSA utilizes SoluMatrix Fine Particle Technology, which creates a smaller particle size formulation of abiraterone acetate tablets. This technology enhances the bioavailability of the drug. Clinical trials have shown that YONSA, when administered with methylprednisolone, is as effective as Zytiga in reducing testosterone levels, but often requires lower dosages[1][4].

Market Impact and Patient Access

The approval of YONSA represents a new treatment option for approximately 30,000 men diagnosed annually in the U.S. with mCRPC. Sun Pharma's commitment to enhancing patient access to innovative cancer therapies is highlighted by the launch of YONSA[1].

Financial Aspects

The financial trajectory of YONSA is influenced by several factors:

Revenue Potential

Given that Zytiga generated $1.23 billion in the U.S. in 2017, the market for mCRPC treatments is substantial. YONSA, as a competitor, is poised to capture a significant share of this market[1].

Licensing and Royalties

Sun Pharma's deal with Churchill Pharmaceuticals includes upfront fees, milestone payments, and royalties. This structure ensures a steady revenue stream for both companies involved in the drug's development and marketing[1].

Generic Competition

The invalidation of Zytiga's patent and the anticipated generic entry following the expiration of a 30-month stay in October 2018 could impact YONSA's market share. However, YONSA's unique formulation and clinical profile may help it maintain a competitive edge[1].

Support Programs and Patient Affordability

To enhance patient access and affordability, Sun Pharma offers the YONSA SUPPORT® Co-Pay Card Program. This program helps eligible, commercially insured patients reduce their out-of-pocket costs for YONSA prescriptions[5].

Side Effects and Safety Considerations

YONSA, like other treatments for mCRPC, comes with potential side effects. These include the risk of high blood pressure, heart effects, and low levels of potassium, which are mitigated by the concurrent use of methylprednisolone. Patients with liver disease or other heart conditions need to be closely monitored by their healthcare providers[2].

Global Drug Shortages and Market Sustainability

While YONSA itself is not currently affected by drug shortages, the broader pharmaceutical market faces challenges related to price erosion, particularly in the generic and biosimilar markets. Low prices in these markets can lead to oligopolies and increase the risk of drug shortages, which could indirectly impact the sustainability and competitiveness of the pharmaceutical industry as a whole[3].

Key Takeaways

• FDA Approval: YONSA received FDA approval in May 2018 for treating mCRPC.
• Competitive Edge: YONSA competes with Zytiga but avoids patent issues, making it a viable alternative.
• Clinical Efficacy: YONSA is as effective as Zytiga in reducing testosterone levels, often with lower dosages.
• Market Impact: YONSA provides a new treatment option for thousands of men with mCRPC.
• Financial Trajectory: Significant revenue potential, supported by licensing and royalty agreements.
• Patient Support: YONSA SUPPORT® Co-Pay Card Program enhances patient affordability.

FAQs

What is YONSA used for?

YONSA is used to treat metastatic castration-resistant prostate cancer (mCRPC) in combination with methylprednisolone[2].

How does YONSA differ from Zytiga?

YONSA and Zytiga contain the same active ingredient, abiraterone acetate, but YONSA uses a different steroid (methylprednisolone) and a proprietary SoluMatrix Fine Particle Technology, which can result in lower dosages[1][4].

What are the potential side effects of YONSA?

Potential side effects include high blood pressure, heart effects, and low levels of potassium, which are mitigated by the use of methylprednisolone[2].

Is YONSA available through any patient support programs?

Yes, the YONSA SUPPORT® Co-Pay Card Program helps eligible patients reduce their out-of-pocket costs for YONSA prescriptions[5].

How does the FDA approval of YONSA impact the market for mCRPC treatments?

The FDA approval of YONSA introduces a new competitor to the market, potentially capturing a significant share of the revenue generated by treatments for mCRPC[1].

Sources

1. Biospace: Sun Pharma Gets FDA Go-Ahead for Yonsa for Prostate Cancer
2. NPS MedicineWise: Yonsa Mpred - Consumer Medicine Information
3. Office of Health Economics: The Dynamics of Drug Shortages
4. FDA: 210308Orig1s000 - Clinical Pharmacology Review
5. YONSA Rx: YONSA SUPPORT® programs provide a simple path to services