Rukobia Patent Expiration

Rukobia is a drug owned by Viiv Healthcare Co. It is protected by 3 US drug patents filed in 2020 out of which none have expired yet. Rukobia's patents have been open to challenges since 02 July, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2029. Details of Rukobia's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7745625 Prodrugs of piperazine and substituted piperidine antiviral agents
Nov, 2027

(3 years from now)

Active
US8461333 Salts of prodrugs of piperazine and substituted piperidine antiviral agents
Feb, 2025

(4 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8168615 Prodrugs of piperazine and substituted piperidine antiviral agents
Jul, 2029

(4 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rukobia's patents.

Given below is the list of recent legal activities going on the following patents of Rukobia.

Activity Date Patent Number
Patent litigations
Patent Term Extension Certificate 11 Mar, 2024 US8168615
Payment of Maintenance Fee, 12th Year, Large Entity 19 Oct, 2023 US8168615
Notice of Final Determination -Eligible 03 Oct, 2023 US8168615
FDA Final Eligibility Letter 10 May, 2023 US8168615
Second letter to regulating agency to determine regulatory review period 16 Feb, 2022 US8168615
Payment of Maintenance Fee, 12th Year, Large Entity 17 Nov, 2021 US7745625
Letter from FDA or Dept of Agriculture re PTE application 01 Mar, 2021 US8168615
Initial letter Re: PTE Application to regulating agency 02 Dec, 2020 US8168615
Payment of Maintenance Fee, 8th Year, Large Entity 28 Sep, 2020 US8461333
Payment of Maintenance Fee, 8th Year, Large Entity 22 Oct, 2019 US8168615


FDA has granted several exclusivities to Rukobia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rukobia, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rukobia.

Exclusivity Information

Rukobia holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Rukobia's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 02, 2025

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Rukobia is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rukobia's family patents as well as insights into ongoing legal events on those patents.

Rukobia's Family Patents

Rukobia has patent protection in a total of 30 countries. It's US patent count contributes only to 32.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Rukobia.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Rukobia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 13, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Rukobia Generics:

There are no approved generic versions for Rukobia as of now.





About Rukobia

Rukobia is a drug owned by Viiv Healthcare Co. Rukobia uses Fostemsavir Tromethamine as an active ingredient. Rukobia was launched by Viiv Hlthcare in 2020.

Approval Date:

Rukobia was approved by FDA for market use on 02 July, 2020.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rukobia is 02 July, 2020, its NCE-1 date is estimated to be 02 July, 2024.

Active Ingredient:

Rukobia uses Fostemsavir Tromethamine as the active ingredient. Check out other Drugs and Companies using Fostemsavir Tromethamine ingredient

Dosage:

Rukobia is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 600MG BASE TABLET, EXTENDED RELEASE Prescription ORAL