RASUVO Drug Patent Profile

When do Rasuvo patents expire, and what generic alternatives are available?

Rasuvo is a drug marketed by Medexus and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in twenty-one countries.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

DrugPatentWatch^® Generic Entry Outlook for Rasuvo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 1, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RASUVO

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RASUVO

Paragraph IV (Patent) Challenges for RASUVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RASUVO	Subcutaneous Injection	methotrexate	7.5 mg/0.15 mL 10 mg/0.2 mL 12.5 mg/0.25 mL 15 mg/0.3 mL 17.5 mg/0.35 mL 20 mg/0.4 mL 22.5 mg/0.45 mL 25 mg/0.5 mL 27.5 mg/0.55 mL 30 mg/0.6 mL	205776	1	2026-05-04

US Patents and Regulatory Information for RASUVO

RASUVO is protected by one US patents.

This potential generic entry date is based on patent 8,664,231.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-001	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-007	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-004	Jul 10, 2014		RX	Yes	Yes	8,664,231

International Patents for RASUVO

When does loss-of-exclusivity occur for RASUVO?

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

Australia

Brazil

Croatia

Denmark

South Korea

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 RASUVO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	14872
Austria	E491455
Australia	2007276387