Tivorbex Patent Expiration

Tivorbex is a drug owned by Genus Lifesciences Inc. It is protected by 3 US drug patents filed from 2014 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 23, 2030. Details of Tivorbex's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9089471 Formulation of indomethacin
Apr, 2030

(5 years from now)

Active
US8734847 Formulation of indomethacin
Apr, 2030

(5 years from now)

Active
US8992982 Formulation of indomethacin
Apr, 2030

(5 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 Tivorbex's patents.

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

Activity Date Patent Number
Patent litigations
7.5 yr surcharge - late pmt w/in 6 mo, Small Entity 07 Feb, 2023 US9089471
Payment of Maintenance Fee, 8th Yr, Small Entity 07 Feb, 2023 US9089471
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 06 Feb, 2023 US9089471
Payment of Maintenance Fee, 8th Yr, Small Entity 30 Sep, 2022 US8992982
Payment of Maintenance Fee, 8th Yr, Small Entity 01 Dec, 2021 US8734847
Payment of Maintenance Fee, 4th Year, Large Entity 28 Jan, 2019 US9089471
Payment of Maintenance Fee, 4th Yr, Small Entity 01 Oct, 2018 US8992982
Payment of Maintenance Fee, 4th Yr, Small Entity 27 Nov, 2017 US8734847
Application ready for PDX access by participating foreign offices 31 Aug, 2015 US8992982
Application ready for PDX access by participating foreign offices 31 Aug, 2015 US9089471


FDA has granted several exclusivities to Tivorbex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tivorbex, 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 Tivorbex.

Exclusivity Information

Tivorbex holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Tivorbex's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Feb 24, 2017

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US patents provide insights into the exclusivity only within the United States, but Tivorbex 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 Tivorbex's family patents as well as insights into ongoing legal events on those patents.

Tivorbex's Family Patents

Tivorbex has patent protection in a total of 21 countries. It's US patent count contributes only to 23.3% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tivorbex.

Family Patents

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Generic Launch

Generic Release Date:

Tivorbex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 23, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tivorbex Generic API suppliers:

Indomethacin is the generic name for the brand Tivorbex. 32 different companies have already filed for the generic of Tivorbex, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tivorbex's generic

Alternative Brands for Tivorbex

Tivorbex which is used for relieving pain., has several other brand drugs in the same treatment category . 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 Treatment Area
Btcp Pharma
Subsys Used for managing pain.
Fresenius Kabi Usa
Morphine Sulfate Used for managing chronic pain and treating pain in patients requiring opioid analgesia.
Recro Gainesville
Zohydro Er Used for managing pain in patients with hepatic impairment.
Tersera
Prialt Used for managing severe chronic pain through intrathecal infusion in patients also receiving morphine.
Upjohn
Lyrica used for managing fibromyalgia, treating various types of pain, and seizure disorders.
Zyla
Zorvolex Used for managing pain.





About Tivorbex

Tivorbex is a drug owned by Genus Lifesciences Inc. It is used for relieving pain. Tivorbex uses Indomethacin as an active ingredient. Tivorbex was launched by Genus in 2014.

Approval Date:

Tivorbex was approved by FDA for market use on 24 February, 2014.

Active Ingredient:

Tivorbex uses Indomethacin as the active ingredient. Check out other Drugs and Companies using Indomethacin ingredient

Treatment:

Tivorbex is used for relieving pain.

Dosage:

Tivorbex is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG CAPSULE Discontinued ORAL
40MG CAPSULE Discontinued ORAL