Prestalia Generic: When Will It Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Prestalia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? October 2029 Its only patent listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic amlodipine besylate and perindopril arginine. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Prestalia as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Prestalia by the Numbers
- Reason
- Not yet clearOne generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
- How sure
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2015 January 2015 FDA Orange Book
- Patents listed 1 last runs to October 2029 FDA Orange Book
Prestalia’s Road to a Generic
Prestalia has had the market to itself since the FDA approved it in January 2015 (Adhera Therapeutics Inc). Its one listed patent runs to October 2029. Generic companies have challenged its patents with the FDA since November 2016.
One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Prestalia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Prestalia’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,846,961 | The active ingredient; the product’s formulation; a way of using it (U-3) | October 2029 | Active |
Source: FDA Orange Book, application 205003. Patent numbers open the patent on Google Patents.
Patent Challenges to Prestalia
The first patent challenge to Prestalia reached the FDA in November 2016, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Prestalia’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg | November 2016 | 1 company | Head start no longer applies decided July 2022 | Not yet | Not yet | October 2029 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Amlodipine Besylate and Perindopril Arginine
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
One company has applied to the FDA to make generic amlodipine besylate and perindopril arginine.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Prestalia’s patents with the FDA since November 2016: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic amlodipine besylate and perindopril arginine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic amlodipine besylate and perindopril arginine for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Prestalia Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Prestalia, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
Prestalia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 10MG BASE;14MG | Tablet | Oral | January 2015 | Discontinued reference product |
| EQ 2.5MG BASE;3.5MG | Tablet | Oral | January 2015 | Discontinued reference product |
| EQ 5MG BASE;7MG | Tablet | Oral | January 2015 | Discontinued reference product |
Source: FDA Orange Book, Adhera Therapeutics Inc. Listed for sale today by Adhera Therapeutics, Inc. (FDA NDC Directory).
What a Generic Prestalia Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Prestalia as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Prestalia”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Prestalia
Is there a generic for Prestalia right now?
No. As of October 9, 2026 no generic amlodipine besylate and perindopril arginine is listed for sale in the FDA NDC Directory.
When will Prestalia go generic?
There is no expected month yet. One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Will generic amlodipine besylate and perindopril arginine be the same as Prestalia?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Prestalia?
Not yet. The FDA Orange Book lists no approved generic version of Prestalia.
When does the Prestalia patent expire?
One patent is listed for Prestalia in the FDA Orange Book; it runs to October 2029. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
Has anyone challenged the Prestalia patents?
Yes. The first patent challenge to Prestalia reached the FDA in November 2016, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Isentress HDRaltegravir Potassium2028 to 2029
- SezabyPhenobarbital SodiumNovember 2029
- OdefseyEmtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide FumarateJanuary 2032
- VizimproDacomitinibSeptember 2032
- DurystaBimatoprostDuring 2041
- AngeliqDrospirenone and EstradiolTBD no date yet
About Prestalia
- Generic name amlodipine besylate and perindopril arginine
- How it is taken By mouth
- Company Adhera Therapeutics Inc
- Patent challenges Since November 2016 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Prestalia
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.