Tivicay is a drug owned by Viiv Healthcare Co. It is protected by 4 US drug patents filed from 2013 to 2023 out of which none have expired yet. Tivicay's patents have been open to challenges since 12 August, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2030. Details of Tivicay'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. | |||
| US9242986 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Dec, 2029
(4 years from now) | Active |
| US8129385 | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Oct, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9242986 (Pediatric) | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Jun, 2030
(5 years from now) | Active |
|
US8129385 (Pediatric) | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Apr, 2028
(2 years from now) | Active |
FDA has granted several exclusivities to Tivicay. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tivicay, 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 Tivicay.
Exclusivity Information
Tivicay holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Tivicay's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-166) | Jul 30, 2018 |
| New Chemical Entity Exclusivity(NCE) | Aug 12, 2018 |
| New Indication(I-758) | Nov 21, 2020 |
Several oppositions have been filed on Tivicay's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tivicay's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tivicay patents.
Tivicay's Oppositions Filed in EPO
Tivicay has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 28, 2014, by Ahrens, Gabriele. This opposition was filed on patent number EP06758843A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17195280A | Feb, 2020 | Gilead Sciences, Inc. | Opposition rejected |
| EP16154531A | Dec, 2018 | Gilead Sciences, Inc. | Patent maintained as amended |
| EP06822311A | Nov, 2016 | Zwicker Schnappauf & Partner PartG mbB | Opposition procedure closed |
| EP06758843A | May, 2014 | Ahrens, Gabriele | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Tivicay 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 Tivicay's family patents as well as insights into ongoing legal events on those patents.
Tivicay's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tivicay's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 08, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tivicay Generics:
There are no approved generic versions for Tivicay as of now.
How can I launch a generic of Tivicay before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tivicay's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tivicay's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Tivicay -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 25 mg and 50 mg | 14 Aug, 2017 | 4 | 08 Dec, 2029 |
Alternative Brands for Tivicay
There are several other brand drugs using the same active ingredient (Dolutegravir Sodium) as Tivicay. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Viiv Hlthcare |
|
About Tivicay
Tivicay is a drug owned by Viiv Healthcare Co. Tivicay uses Dolutegravir Sodium as an active ingredient. Tivicay was launched by Viiv Hlthcare in 2016.
Approval Date:
Tivicay was approved by FDA for market use on 09 June, 2016.
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 Tivicay is 09 June, 2016, its NCE-1 date is estimated to be 12 August, 2017.
Active Ingredient:
Tivicay uses Dolutegravir Sodium as the active ingredient. Check out other Drugs and Companies using Dolutegravir Sodium ingredient
Dosage:
Tivicay is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |