RUKOBIA Drug Patent Profile

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

Rukobia is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rukobia

Rukobia will be eligible for patent challenges on July 2, 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 November 19, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RUKOBIA

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	194
Drug Prices:	Drug price information for RUKOBIA
What excipients (inactive ingredients) are in RUKOBIA?	RUKOBIA excipients list
DailyMed Link:	RUKOBIA at DailyMed

See drug prices for RUKOBIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RUKOBIA

NDA:

212950

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*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.

Recent Clinical Trials for RUKOBIA

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

Sponsor	Phase
Orlando Immunology Center	Phase 4
ViiV Healthcare	Phase 4

See all RUKOBIA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RUKOBIA

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for RUKOBIA

RUKOBIA is protected by three US patents and one FDA Regulatory Exclusivity.

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 RUKOBIA

FDA Regulatory Exclusivity protecting RUKOBIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes				Y
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes			Y

International Patents for RUKOBIA

When does loss-of-exclusivity occur for RUKOBIA?

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

Argentina

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Georgia, Republic of

Germany

Hong Kong

Israel

Japan

Malaysia

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 RUKOBIA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	384728
Malaysia	139243	PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS.
China	101941990	Prodrugs of piperazine and substituted piperidine antiviral agents