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Last Updated: August 17, 2022

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 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

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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: 44
Clinical Trials: 1
Patent Applications: 148
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
Drug Prices for RUKOBIA

See drug prices for RUKOBIA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for RUKOBIA
Generic Entry Date for RUKOBIA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Orlando Immunology CenterPhase 4
ViiV HealthcarePhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts of prodrugs of piperazine and substituted piperidine antiviral agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting RUKOBIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Patent: 8039
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05223736
Estimated Expiration: See Plans and Pricing

Austria

Patent: 4728
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0508876
Estimated Expiration: See Plans and Pricing

Canada

Patent: 60253
Estimated Expiration: See Plans and Pricing

China

Patent: 53985
Estimated Expiration: See Plans and Pricing

Patent: 1941990
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0080064
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 07419
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 25569
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 25569
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0094736
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005004517
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 96687
Estimated Expiration: See Plans and Pricing

Patent: 48533
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7945
Estimated Expiration: See Plans and Pricing

Patent: 1961
Estimated Expiration: See Plans and Pricing

Japan

Patent: 34318
Estimated Expiration: See Plans and Pricing

Patent: 07529519
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9243
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9867
Estimated Expiration: See Plans and Pricing

Patent: 5294
Estimated Expiration: See Plans and Pricing

Norway

Patent: 6742
Estimated Expiration: See Plans and Pricing

Patent: 064062
Estimated Expiration: See Plans and Pricing

Peru

Patent: 051151
Estimated Expiration: See Plans and Pricing

Poland

Patent: 25569
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 25569
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 74256
Estimated Expiration: See Plans and Pricing

Patent: 06136390
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 567
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 25569
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0607466
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1153594
Estimated Expiration: See Plans and Pricing

Patent: 060129533
Estimated Expiration: See Plans and Pricing

Spain

Patent: 99022
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44843
Estimated Expiration: See Plans and Pricing

Patent: 0600096
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 297
Estimated Expiration: See Plans and Pricing

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
Canada 2560253 PRODROGUES DE PIPERAZINE ET AGENTS ANTIVIRAUX DE PIPERIDINE SUBSTITUEE (PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS) See Plans and Pricing
European Patent Office 1725569 PRODROGUES DE PIPERAZINE ET AGENTS ANTIVIRAUX DE PIPERIDINE SUBSTITUEE (PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS) See Plans and Pricing
Brazil PI0508876 pró medicamentos de agentes antivirais de piperazina e piperidina substituìda See Plans and Pricing
Georgia, Republic of P20094736 PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005090367 See Plans and Pricing
Israel 211961 פרודראגים של תרכובות אנטיויראליות של פיפרזין ופיפרידין מותמר (Prodrugs of piperazine and substituted piperidine antiviral agents) See Plans and Pricing
Argentina 048039 PROFARMACOS DE PIPERAZINA Y AGENTES ANTIVIRALES DE PIPERIDINA SUSTITUIDOS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Moodys
Mallinckrodt
Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.