VILTEPSO Drug Patent Profile

Which patents cover Viltepso, and when can generic versions of Viltepso launch?

Viltepso is a drug marketed by Nippon Shinyaku and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in VILTEPSO is viltolarsen. One supplier is listed for this compound. Additional details are available on the viltolarsen profile page.

DrugPatentWatch^® Generic Entry Outlook for Viltepso

Viltepso will be eligible for patent challenges on August 12, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VILTEPSO

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VILTEPSO?	VILTEPSO excipients list
DailyMed Link:	VILTEPSO at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VILTEPSO

NDA:

212154

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for VILTEPSO

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for VILTEPSO

VILTEPSO is protected by two US patents and two FDA Regulatory Exclusivities.

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

Patents protecting VILTEPSO

FDA Regulatory Exclusivity protecting VILTEPSO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nippon Shinyaku	VILTEPSO	viltolarsen	SOLUTION;INTRAVENOUS	212154-001	Aug 12, 2020		RX	Yes	Yes			Y	Y
Nippon Shinyaku	VILTEPSO	viltolarsen	SOLUTION;INTRAVENOUS	212154-001	Aug 12, 2020		RX	Yes	Yes
Nippon Shinyaku	VILTEPSO	viltolarsen	SOLUTION;INTRAVENOUS	212154-001	Aug 12, 2020		RX	Yes	Yes			Y	Y
Nippon Shinyaku	VILTEPSO	viltolarsen	SOLUTION;INTRAVENOUS	212154-001	Aug 12, 2020		RX	Yes	Yes

International Patents for VILTEPSO

When does loss-of-exclusivity occur for VILTEPSO?

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

Australia

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Russian Federation

San Marino

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 VILTEPSO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6141728
Japan	5363655
Japan	6867620
Japan	2021104037	アンチセンス核酸 (ANTISENSE NUCLEIC ACID)
Japan	2019062913	アンチセンス核酸 (ANTISENSE NUCLEIC ACID)
Japan	6867621
Taiwan	201215408	Antisense nucleic acid