Rukobia is a drug owned by Viiv Healthcare Co. It is protected by 3 US drug patents filed in 2020. Out of these, 2 drug patents are active and 1 has expired. 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
(2 years from now) | Active |
| US8461333 | Salts of prodrugs of piperazine and substituted piperidine antiviral agents |
Feb, 2025
(2 months ago) |
Expired
|
| 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.
Latest 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 Term Extension Certificate Critical | 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 Critical | 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 |
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
Explore Our Curated Drug Screens
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 |