Verquvo Generic: When Will Generic Vericiguat Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Verquvo Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? January 2035 About 8.5 years away Why then?
  2. Has the FDA approved a generic? Not yet 2 companies hold tentative approvals Why not yet?
  3. When does the last patent end? November 2032 6 patents listed with the FDA
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic vericiguat is expected to be available in January 2035, about 8.5 years away. None is for sale yet.

Why January 2035?

It is when Verquvo’s patent 8,420,656 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.

Why hasn’t the FDA approved a generic yet?

That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. 2 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Changzhou Pharmaceutical Factory (April 2026) and Torrent Pharmaceuticals Ltd (April 2026). See who is lined up

Will the generic cost less?

Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $22.73 pharmacies pay per tablet for Verquvo today to about $6.14. See the price estimate

What should I do now?

Keep taking Verquvo 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.

Verquvo by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
Price competition
Strong 5 companies have filed, 5 first in line
Brand sales
$96M a yearSmaller seller
  • FDA approved 2021 January 2021 FDA Orange Book
  • Patents listed 6 last runs to November 2032 FDA Orange Book
  • Pharmacies pay $22.73 per tablet, up 6.8% in a year NADAC, October 2026
  • Medicare Part D spent $64.8M in 2025, for 13.4K people CMS Part D Spending by Drug
  • Medicaid prescriptions 6,327 in the last four reported quarters, $5.8M CMS Medicaid drug utilization, to Q1 2026

Verquvo’s Road to a Generic

Verquvo has had the market to itself since the FDA approved it in January 2021 (Merck Sharp And Dohme LLC). Its FDA protection (new dosing) runs to January 2029. Its 6 listed patents run to November 2032. Generic companies have challenged its patents with the FDA since January 2025.

The first generic of Verquvo is expected in January 2035.

Why that month: patent 8,420,656, on the active ingredient and the product’s formulation, ends then.

Brand alone on the market Since FDA approval, January 2021
New chemical entity Ended January 2026
New dosing Ends January 2029
Patent 8,420,656 Expires May 2031 The patent behind the expected month of generic availability
Patent 8,921,377 Expires May 2031
Patent 9,993,476 Expires May 2031
Patent 10,736,896 Expires May 2031
Patent 11,439,642 Expires May 2031
Patent 9,604,948 Expires November 2032
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Verquvo Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Verquvo’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.

The one that matters for a generic launch: patent 8,420,656, which ends in May 2031; the first generic is expected after it, in January 2035, about 8.5 years away.

Patents listed with the FDA (6)
PatentWhat it coversProtects untilStatus
8,420,656 Sets the expected month of generic availability The active ingredient; the product’s formulation May 2031 Active
8,921,377 A way of using it (U-3062) May 2031 Active
9,993,476 A way of using it (U-3062) May 2031 Active
10,736,896 The active ingredient; the product’s formulation May 2031 Active
11,439,642 A way of using it (U-3062) May 2031 Active
9,604,948 The active ingredient; the product’s formulation; a way of using it (U-3062) November 2032 Active
FDA exclusivities (2)
ExclusivityWhat it meansEndsStatus
New chemical entity NCEFive years of protection for a medicine whose active ingredient the FDA had never approved before.January 2026Ended
New dosing D-198Three years of protection for a new way of dosing it.January 2029Active

Source: FDA Orange Book, application 214377. Patent numbers open the patent on Google Patents.

Patent Challenges to Verquvo

The first patent challenge to Verquvo reached the FDA in January 2025, from 5 companies on that first day. The FDA’s list has 2 entries for Verquvo, by form and strength. 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 Verquvo’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.

Patent challenges on the FDA’s list (2)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Tablets, 2.5 mg January 2025 5 companies No decision yet Not yet Not yet November 2032
Tablets, 5 mg and 10 mg January 2025 4 companies No decision yet Not yet Not yet November 2032

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 Vericiguat

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.

1

Applied to the FDA

5 companies have applied to the FDA to make generic vericiguat.

The FDA has tentatively approved 2 companies’ generics: Changzhou Pharmaceutical Factory (April 2026) and Torrent Pharmaceuticals Ltd (April 2026). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.

The FDA keeps the other applications private until it acts on them, so those companies are not named here.

First in line. 5 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.

Generic companies have challenged Verquvo’s patents with the FDA since January 2025: see the patent challenges.

2

Approved by the FDA

Not yet. The FDA has not approved a generic vericiguat. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic vericiguat 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).

Verquvo Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Verquvo 2.5 mg tablet

$22.73 per tablet in October 2026, up 6.8% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

  • Verquvo 2.5 mg tablet $22.73 per tablet
  • Verquvo 5 mg tablet $22.73 per tablet
  • Verquvo 10 mg tablet $22.72 per tablet
See the numbers
MonthPharmacies paid per tablet
October 2026$22.73
September 2026$22.73
August 2026$22.73
July 2026$22.74
June 2026$22.74
May 2026$22.76
April 2026$22.70
March 2026$22.70
February 2026$22.70
January 2026$22.70
February 2024$21.28
January 2024$21.28

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

What Pharmacies Pay for Verquvo Today$22.73per tablet · October 2026
Our Estimate for Generic Verquvoabout $6.14per tablet once generics reach pharmacies, about 73% less than today

How we estimate it. We start from what pharmacies pay for Verquvo today: $22.73 per tablet for Verquvo 2.5 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Verquvo has 5 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.

Dollar figures apply FDA’s median drops to the $22.73 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

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.

What Medicare and Medicaid Spend on Verquvo

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Verquvo, before manufacturer rebates.

$16.1M
January to March 2026, the latest CMS has posted
For 8,573 people, about $1,106 per prescription fill
$64.8M
2025, the whole year
For 13,414 people, about $1,073 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$16,143,9988,573$1,105.53
2025$64,769,99513,414$1,072.79

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Verquvo only, so no generic is counted in it. What CMS says it is used for: Vericiguat is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure.

Medicaid Prescriptions by Quarter

6,327 prescriptions in the four quarters to Q1 2026, $5.8M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 20261,074$1,032,179
Q4 20251,668$1,521,853
Q3 20251,918$1,739,093
Q2 20251,667$1,459,038
Q1 20251,697$1,475,481

Source: CMS Medicaid State Drug Utilization Data, over Verquvo’s own package codes.

Verquvo Strengths and Forms

StrengthFormHow it is takenApprovedStatus
10MGTabletOralJanuary 2021Prescription reference product
2.5MGTabletOralJanuary 2021Prescription reference product
5MGTabletOralJanuary 2021Prescription reference product

Source: FDA Orange Book, Merck Sharp And Dohme LLC. Listed for sale today by Merck Sharp & Dohme LLC (FDA NDC Directory).

Verquvo NDC Codes and Packages

Each Verquvo package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Verquvo packages (24)
NDCProductPackageCompany
00006-5030-01VERICIGUAT 10 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5030-01VERICIGUAT 10 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5030-02VERICIGUAT 10 mg/1 tablet, film coatedbottle of 90 tabletsMerck Sharp & Dohme LLC
00006-5030-02VERICIGUAT 10 mg/1 tablet, film coatedbottle of 90 tabletsMerck Sharp & Dohme LLC
00006-5030-03VERICIGUAT 10 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5030-04VERICIGUAT 10 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5030-04VERICIGUAT 10 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5028-01VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
Show the other 16 Verquvo packages
NDCProductPackageCompany
00006-5028-01VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5028-02VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5028-02VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5028-04VERICIGUAT 2.5 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5028-04VERICIGUAT 2.5 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5028-06VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5028-06VERICIGUAT 2.5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5029-01VERICIGUAT 5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5029-01VERICIGUAT 5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5029-02VERICIGUAT 5 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5029-02VERICIGUAT 5 mg/1 tablet, film coatedbottle of 30 tabletsMerck Sharp & Dohme LLC
00006-5029-04VERICIGUAT 5 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5029-04VERICIGUAT 5 mg/1 tablet, film coatedcarton of 10 blister packs of 10 tabletsMerck Sharp & Dohme LLC
00006-5029-05VERICIGUAT 5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5029-06VERICIGUAT 5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC
00006-5029-06VERICIGUAT 5 mg/1 tablet, film coatedbottle of 14 tabletsMerck Sharp & Dohme LLC

Source: the FDA NDC Directory, current listings only. Only packages sold under Verquvo’s own FDA approval (NDA 214377) are listed, never a generic. Some codes belong to companies that repackage Verquvo: it is the same medicine in a different package.

What a Generic Verquvo Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Verquvo 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 Verquvo”. 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 Verquvo

Is there a generic for Verquvo right now?

No. As of October 9, 2026 no generic vericiguat is listed for sale in the FDA NDC Directory.

When will Verquvo go generic?

January 2035 is the expected month, and that is likely but not certain. It is when Verquvo’s patent 8,420,656 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.

Will generic vericiguat be the same as Verquvo?

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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $22.73 pharmacies pay per tablet for Verquvo today to about $6.14. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Verquvo?

Not yet. The FDA Orange Book lists no approved generic version of Verquvo.

When does the Verquvo patent expire?

The FDA Orange Book lists 6 patents for Verquvo; the last runs to November 2032. The one behind the expected month is patent 8,420,656, which ends in May 2031. 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 month on this page (January 2035) weighs all of that.

Has anyone challenged the Verquvo patents?

Yes. The first patent challenge to Verquvo reached the FDA in January 2025, from 5 companies 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.

How much does Verquvo cost now?

Pharmacies paid about $22.73 per tablet for Verquvo 2.5 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected January 2035 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

All upcoming generics

About Verquvo

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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.