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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6696481 | Salt of perindopril and pharmaceutical compositions containing it |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US7846961 | α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it |
Oct, 2029
(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 Prestalia's patents.
Latest Legal Activities on Prestalia's Patents
Given below is the list of recent legal activities going on the following patents of Prestalia.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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 |
|---|---|---|---|
 | |||
| 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
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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 |
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.
Market Authorisation 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 10MG BASE;14MG | TABLET | Prescription | ORAL |
| EQ 2.5MG BASE;3.5MG | TABLET | Prescription | ORAL |
| EQ 5MG BASE;7MG | TABLET | Prescription | ORAL |