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
(3 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
(1 year, 6 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). | |||
|
US9242986 (Pediatric) | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Jun, 2030
(4 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 |
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 Tivicay Pd's patents.
Latest Legal Activities on Tivicay Pd's Patents
Given below is the list of recent legal activities going on the following patents of Tivicay Pd.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change | 14 Nov, 2024 | US8129385 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Aug, 2023 | US8129385 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9242986 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Aug, 2019 | US8129385 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jun, 2019 | US9242986 |
| Post Issue Communication - Certificate of Correction | 20 Apr, 2017 | US9242986 |
| Recordation of Patent Grant Mailed | 26 Jan, 2016 | US9242986 |
| Patent Issue Date Used in PTA Calculation | 26 Jan, 2016 | US9242986 |
| Email Notification | 07 Jan, 2016 | US9242986 |
| Issue Notification Mailed | 06 Jan, 2016 | US9242986 |
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
Explore Our Curated Drug Screens
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 21 Jul, 2021 | 08 Dec, 2029 | Less |
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 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 |