Prestalia Patent Expiration

Prestalia is a drug owned by Adhera Therapeutics Inc. It is protected by 2 US drug patents filed in 2015. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 05, 2029. Details of Prestalia'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.
US7846961 α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
Oct, 2029

(4 years from now)

Active
US6696481 Salt of perindopril and pharmaceutical compositions containing it
Apr, 2023

(1 year, 8 months 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 Prestalia's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 23 May, 2022 US7846961
Payment of Maintenance Fee, 8th Year, Large Entity 17 Apr, 2018 US7846961
Post Issue Communication - Certificate of Correction 11 Apr, 2011 US7846961
Recordation of Patent Grant Mailed 07 Dec, 2010 US7846961
Patent Issue Date Used in PTA Calculation 07 Dec, 2010 US7846961
Issue Notification Mailed 17 Nov, 2010 US7846961
Dispatch to FDC 11 Nov, 2010 US7846961
Application Is Considered Ready for Issue 02 Nov, 2010 US7846961
Issue Fee Payment Verified 21 Oct, 2010 US7846961
Issue Fee Payment Received 21 Oct, 2010 US7846961


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

Exclusivity Information

Prestalia holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Prestalia's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jan 21, 2018

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Several oppositions have been filed on Prestalia'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 Prestalia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Prestalia patents.

Prestalia's Oppositions Filed in EPO

Prestalia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 13, 2005, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP03290383A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07731039A Jan, 2017 Strawman Limited Revoked
EP07731039A Jan, 2017 LEK Pharmaceuticals d.d. Revoked
EP03290383A Apr, 2005 Teva Pharmaceutical Industries Ltd. Opposition rejected


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

Prestalia's Family Patents

Prestalia has patent protection in a total of 41 countries. It's US patent count contributes only to 2.9% of its total global patent coverage. 11 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 Prestalia.

Family Patents

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Generic Launch

Generic Release Date:

Prestalia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 05, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Prestalia Generics:

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

How can I launch a generic of Prestalia before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Prestalia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prestalia'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 Prestalia -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg 04 Nov, 2016 1 05 Oct, 2029 Extinguished

Alternative Brands for Prestalia

Prestalia which is used for treating high blood pressure., 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
Abbott
Hytrin Used for treating hypertension and symptomatic benign prostatic hyperplasia.
Abbvie
Teveten Used for managing high blood pressure.
Teveten Hct Used for managing high blood pressure.
Allergan
Bystolic Used for treating high blood pressure.
Ani Pharms
Atacand Hct Used for treating high blood pressure.
Azurity
Edarbi Used for lowering blood pressure.
Epaned Used for managing heart failure and hypertension.
Edarbyclor Used for managing high blood pressure.
Boehringer Ingelheim
Twynsta Used for managing high blood pressure.
Micardis Used for the treatment of cardiovascular conditions such as myocardial infarction, hypertension, and stroke.
Micardis Hct Used for lowering high blood pressure.
Cosette
Azor Used for managing high blood pressure.
Benicar Used for lowering high blood pressure.
Tribenzor Used for lowering high blood pressure.
Benicar Hct Used for managing high blood pressure.
Noden Pharma
Tekturna Used for treating high blood pressure.
Tekturna Hct Used for lowering high blood pressure.
Novartis
Diovan Used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction.
Exforge Used for treating high blood pressure.
Tekamlo Used for treating high blood pressure.
Valturna Used for managing high blood pressure.
Amturnide Used for lowering high blood pressure (hypertension).
Diovan Hct Used for treating high blood pressure.
Exforge Hct Used for treating high blood pressure.
Upjohn
Inspra Used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor.
Waylis Therap
Coreg Cr Used for managing congestive heart failure and hypertension to reduce mortality.





About Prestalia

Prestalia is a drug owned by Adhera Therapeutics Inc. It is used for treating high blood pressure. Prestalia uses Amlodipine Besylate; Perindopril Arginine as an active ingredient. Prestalia was launched by Adhera in 2015.

Approval Date:

Prestalia was approved by FDA for market use on 21 January, 2015.

Active Ingredient:

Prestalia uses Amlodipine Besylate; Perindopril Arginine as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Perindopril Arginine ingredient

Treatment:

Prestalia is used for treating high blood pressure.

Dosage:

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

Strength Dosage Form Availability Application Pathway
EQ 5MG BASE;7MG TABLET Discontinued ORAL
EQ 10MG BASE;14MG TABLET Discontinued ORAL
EQ 2.5MG BASE;3.5MG TABLET Discontinued ORAL