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RUKOBIA Drug Patent Profile

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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 was eligible for patent challenges on July 2, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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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:	45
Drug Prices:	Drug price information for RUKOBIA
What excipients (inactive ingredients) are in RUKOBIA?	RUKOBIA excipients list
DailyMed Link:	RUKOBIA at DailyMed

Drug patent expirations by year for RUKOBIA

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

Generic Entry Date for RUKOBIA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
ViiV Healthcare	Phase 4
Orlando Immunology Center	Phase 4

See all RUKOBIA clinical trials

US Patents and Regulatory Information for RUKOBIA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RUKOBIA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Salts of prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting RUKOBIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

International Patents for RUKOBIA

See the table below for patents covering RUKOBIA around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1096687	Prodrugs of piperazine and substituted piperidine antiviral agents	⤷ Sign Up
Croatia	P20080064		⤷ Sign Up
Georgia, Republic of	P20094736	PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS	⤷ Sign Up
Cyprus	1107419		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration