XADAGO Drug Patent Profile

When do Xadago patents expire, and when can generic versions of Xadago launch?

Xadago is a drug marketed by Mdd Us and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xadago

A generic version of XADAGO was approved as safinamide mesylate by PRINSTON INC on April 25^th, 2024.

Summary for XADAGO

International Patents:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	5
Patent Applications:	593
Drug Prices:	Drug price information for XADAGO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XADAGO
What excipients (inactive ingredients) are in XADAGO?	XADAGO excipients list
DailyMed Link:	XADAGO at DailyMed

See drug prices for XADAGO

Recent Clinical Trials for XADAGO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zambon SpA	Phase 2
Alain Kaelin	Phase 4
Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 4

See all XADAGO clinical trials

Pharmacology for XADAGO

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Monoamine Oxidase-B Inhibitors

US Patents and Regulatory Information for XADAGO

XADAGO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No			Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes				Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No				Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes			Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes

International Patents for XADAGO

When does loss-of-exclusivity occur for XADAGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

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 XADAGO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2342929	СПОСОБЫ ЛЕЧЕНИЯ БОЛЕЗНИ ПАРКИНСОНА (METHODS OF PARKINSON'S DISEASE TREATMENT)
Cyprus	1115951
Germany	602004021790
European Patent Office	2070526	Procedes de traitment de la maladie de Parkinson (Methods for treatment of Parkinson's disease)
Norway	20131417
Cyprus	1115286
Hungary	S1500043

Supplementary Protection Certificates for XADAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	46/2015	Austria		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	CA 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
1613296	15C0054	France		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	C20150033 00258	Estonia		PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015
1613296	300752	Netherlands		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226

XADAGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xadago

Introduction to Xadago

Xadago, also known as safinamide, is a groundbreaking drug developed by Newron Pharmaceuticals for the treatment of Parkinson's disease. It is the first new chemical entity (NCE) approved for this condition in over a decade, addressing motor fluctuations in patients taking levodopa/carbidopa combinations[4].

Approval and Launch

Xadago gained FDA approval in March 2017 and was subsequently launched in the US market. Prior to its US launch, it was approved and launched in the EU in 2015 and in Japan and Canada in 2019. The drug is marketed by different partners in various regions, including Zambon and Meiji Seika, with US rights initially held by US WorldMeds and later transferred to Supernus Pharma[1][4].

Clinical Significance

Xadago has shown significant clinical benefits in reducing motor fluctuations and increasing "on" time for Parkinson's patients. Clinical trials involving over 1,200 patients demonstrated that participants receiving Xadago experienced more "on" time compared to those on placebo[4].

Market Penetration

Despite its clinical success, Xadago's market penetration has faced several challenges. The drug's uptake in the US market has been hampered by the availability of cheap generic versions of Teva’s Azilect (rasagiline), which belongs to the same drug class as Xadago. This competition has limited the revenue potential for Xadago in the US[1].

Global Reach

Xadago is now available in 12 different countries, including the EU, US, Japan, and Canada. Newron continues to work on expanding its reach to new countries and contracting new commercialization and distribution partners[1].

Financial Performance

Revenue Growth

Xadago has been a key driver of revenue growth for Newron Pharmaceuticals. In FY 2023, Xadago royalties increased by 13% to EUR 6.7 million, contributing significantly to Newron's total revenue of EUR 9.1 million, which saw a 49% increase from the previous year[1].

Royalty Structure

Newron receives royalties from its partners Zambon and Meiji Seika. The royalty rates vary by region, with Newron expecting to receive between 10-12% in the EU and rest of the world, 7% in the US, and 2.5% in Japan[1].

Generic Competition

The entry of generic versions of Xadago into the US market, expected no earlier than December 2027 due to a settlement agreement with generic manufacturers, will likely impact future revenue. However, Supplementary Protection Certificates (SPCs) approved in most major markets will provide protection until 2029[1].

Financial Projections

Newron calculates a net present value (NPV) of CHF 1.9 per share for Xadago, with peak sales estimated at around EUR 90 million. This projection is based on the drug's current market performance and the anticipated impact of generic competition[1].

Partnership and Licensing

The licensing agreements with Zambon and Meiji Seika have been crucial for Xadago's global distribution. In the US, Supernus Pharma now handles the marketing and sales, which has helped in maintaining a presence despite the competitive landscape[1][4].

Challenges and Opportunities

Competition from Generics

The presence of generic versions of similar drugs, such as Teva’s Azilect, continues to pose a significant challenge to Xadago’s market share and revenue growth in the US[1].

Expansion and Partnerships

Newron is focusing on expanding Xadago’s reach to new countries and exploring new partnerships to enhance its commercialization efforts. This strategy aims to mitigate the impact of generic competition and maintain revenue growth[1].

Key Takeaways

• Clinical Significance: Xadago is a clinically significant drug for treating Parkinson’s disease, offering improved "on" time for patients.
• Market Challenges: The drug faces competition from generic versions of similar drugs, particularly in the US market.
• Financial Performance: Xadago has driven significant revenue growth for Newron, with royalties expected to continue contributing to the company’s financial health.
• Future Projections: Peak sales are estimated at EUR 90 million, with protection from generic competition until 2029 due to SPCs.
• Expansion Strategies: Newron is working on expanding Xadago’s global reach and exploring new partnerships to maintain market presence.

FAQs

Q: What is Xadago used for? A: Xadago (safinamide) is used as an add-on treatment for patients with Parkinson's disease who experience motor fluctuations while taking levodopa/carbidopa combinations.

Q: When was Xadago approved in the US? A: Xadago was approved by the FDA in March 2017 and launched in the US market shortly thereafter[4].

Q: Who are the key partners for Xadago? A: Newron Pharmaceuticals has partnered with Zambon and Meiji Seika for global distribution, with US rights currently held by Supernus Pharma[1][4].

Q: How does generic competition affect Xadago? A: Generic versions of similar drugs, such as Teva’s Azilect, have significantly impacted Xadago’s market share and revenue growth in the US. Generic versions of Xadago are expected to enter the US market no earlier than December 2027[1].

Q: What are the financial projections for Xadago? A: Newron projects peak sales of around EUR 90 million for Xadago, with an NPV of CHF 1.9 per share. The drug is expected to continue generating significant royalties until 2029 due to SPCs[1].

Cited Sources

1. Newron Pharmaceuticals - vL Report 25MAR24.pdf
2. Supernus Pharmaceuticals - Third Quarter 2024 Financial Results
3. Edison Investment Research - Newron Pharmaceuticals
4. BioPharma Dive - Parkinson's drug Xadago launches in US
5. Supernus Pharmaceuticals - Fourth Quarter and Full Year 2023 Financial Results