Zontivity Patent Expiration

Zontivity is a drug owned by Key Therapeutics Llc. It is protected by 3 US drug patents filed from 2014 to 2018. Out of these, 1 drug patents are active and 2 have expired. Zontivity's patents have been open to challenges since 08 May, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2027. Details of Zontivity'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.
US7304078 Thrombin receptor antagonists
Dec, 2027

(3 years from now)

Active
US7713999 Thrombin receptor antagonists
May, 2024

(6 months ago)

Expired
US7235567 Crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist
Jun, 2021

(3 years ago)

Expired


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 Zontivity's patents.

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

Activity Date Patent Number
Patent litigations
Court Processing Terminated 02 Apr, 2024 US7304078
Payment of Maintenance Fee, 12th Year, Large Entity 29 Sep, 2021 US7713999
Email Notification 09 Nov, 2020 US7713999
Change in Power of Attorney (May Include Associate POA) 09 Nov, 2020 US7713999
Correspondence Address Change 05 Nov, 2020 US7713999
Change in Power of Attorney (May Include Associate POA) 03 Nov, 2020 US7235567
Email Notification 03 Nov, 2020 US7235567
Correspondence Address Change 01 Nov, 2020 US7235567
Patent Term Extension Certificate 03 Sep, 2020 US7304078
Notice of Final Determination -Eligible 29 Jun, 2020 US7304078


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

Exclusivity Information

Zontivity holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Zontivity's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 08, 2019

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

Zontivity's Family Patents

Zontivity has patent protection in a total of 37 countries. It's US patent count contributes only to 11.5% of its total global patent coverage. 18 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 Zontivity.

Family Patents

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Generic Launch

Generic Release Date:

Zontivity's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Zontivity Generics:

There are no approved generic versions for Zontivity as of now.





About Zontivity

Zontivity is a drug owned by Key Therapeutics Llc. It is used for preventing heart attacks and strokes in patients with a history of heart attack or peripheral arterial disease. Zontivity uses Vorapaxar Sulfate as an active ingredient. Zontivity was launched by Key Therap in 2014.

Approval Date:

Zontivity was approved by FDA for market use on 08 May, 2014.

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 Zontivity is 08 May, 2014, its NCE-1 date is estimated to be 08 May, 2018.

Active Ingredient:

Zontivity uses Vorapaxar Sulfate as the active ingredient. Check out other Drugs and Companies using Vorapaxar Sulfate ingredient

Treatment:

Zontivity is used for preventing heart attacks and strokes in patients with a history of heart attack or peripheral arterial disease.

Dosage:

Zontivity is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 2.08MG BASE TABLET Discontinued ORAL