Tivicay Pd is a drug owned by Viiv Healthcare Co. It is protected by 4 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2030. Details of Tivicay Pd'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
(3 years from now) | Active |
Several oppositions have been filed on Tivicay Pd'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 Pd's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tivicay Pd patents.
Tivicay Pd's Oppositions Filed in EPO
Tivicay Pd 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 Pd 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 Pd's family patents as well as insights into ongoing legal events on those patents.
Tivicay Pd's Family Patents
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Generic Launch
Generic Release Date:
Tivicay Pd's generic launch date based on the expiry of its last outstanding patent 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 Pd Generics:
There are no approved generic versions for Tivicay Pd as of now.
How can I launch a generic of Tivicay Pd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tivicay Pd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tivicay Pd'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 Pd -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 21 Jul, 2021 | 1 | 08 Dec, 2029 |
Alternative Brands for Tivicay Pd
There are several other brand drugs using the same active ingredient (Dolutegravir Sodium) as Tivicay Pd. 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 Pd
Tivicay Pd is a drug owned by Viiv Healthcare Co. Tivicay Pd uses Dolutegravir Sodium as an active ingredient. Tivicay Pd was launched by Viiv Hlthcare in 2020.
Approval Date:
Tivicay Pd was approved by FDA for market use on 12 June, 2020.
Active Ingredient:
Tivicay Pd uses Dolutegravir Sodium as the active ingredient. Check out other Drugs and Companies using Dolutegravir Sodium ingredient
Dosage:
Tivicay Pd is available in tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET, FOR SUSPENSION | Prescription | ORAL |