Attruby Generic: When Will Generic Acoramidis 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

Attruby Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? March 2039 About 12.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the brand’s protection end? August 2039 The last of 13 listed patents Why sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist

Generic acoramidis hydrochloride is expected to be available in March 2039, about 12.5 years away. None is for sale yet.

Why March 2039?

It is when Attruby’s patent 11,058,668 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.

If Attruby’s protection runs to August 2039, how can a generic come sooner?

The 3 patents that run past the expected month, to August 2039 (11,260,047, 12,005,043 and 12,539,290), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic

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. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).

Will the generic cost less?

Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern

What should I do now?

Keep taking Attruby 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.

Attruby by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Toss-up Still unsettled. Just as likely to slip as to hold.
Price competition
None filed yet No filers on record
Brand sales
$518M a yearBig seller
  • FDA approved 2024 November 2024 FDA Orange Book
  • Patents listed 13 last runs to August 2039 FDA Orange Book
  • Medicare Part D spent $405.7M in 2025, for 3,546 people CMS Part D Spending by Drug
  • Medicaid prescriptions 69 in the last four reported quarters, $1.3M CMS Medicaid drug utilization, to Q1 2026

Attruby’s Road to a Generic

Attruby has had the market to itself since the FDA approved it in November 2024 (Bridgebio Pharma Inc). Its FDA protection (orphan drug) runs to November 2031. Its 13 listed patents run to August 2039.

The first generic of Attruby is expected in March 2039.

Why that month: patent 11,058,668, on a way of using it, ends then. That is a few months before the last listed patent runs out, in August 2039.

Brand alone on the market Since FDA approval, November 2024
New chemical entity Ends November 2029
Orphan drug Ends November 2031
Patent 10,513,497 Expires February 2038
Patent 11,058,668 Expires March 2039 The patent behind the expected month of generic availability
Patent 12,070,449 Expires March 2039
Patent 11,260,047 Expires August 2039
Patent 12,005,043 Expires August 2039
Patent 12,539,290 Expires August 2039
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on the formulation Patent on a use First generic expected 7 more patents end earlier; every patent is in the table below. Swipe the chart sideways to see every year.

Why a Generic Can Come Before August 2039

The last listed patent runs to August 2039, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains

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.

Attruby Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Attruby’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 11,058,668, which ends in March 2039, the month the first generic is expected. Why the later ones may not hold it back

Patents listed with the FDA (13)
PatentWhat it coversProtects untilStatus
8,877,795 The product’s formulation May 2031 Active
9,169,214 The product’s formulation; a way of using it (U-4046) May 2031 Active
9,642,838 The active ingredient; the product’s formulation May 2031 Active
9,913,826 A way of using it (U-4046) May 2031 Active
10,398,681 The product’s formulation May 2031 Active
10,842,777 A way of using it (U-4046) May 2031 Active
10,513,497 The active ingredient February 2038 Active
11,919,865 A way of using it (U-4046) February 2038 Active
11,058,668 Sets the expected month of generic availability A way of using it (U-4046) March 2039 Active
12,070,449 A way of using it (U-4046) March 2039 Active
11,260,047 The product’s formulation August 2039 Active
12,005,043 The product’s formulation; a way of using it (U-4046) August 2039 Active
12,539,290 The product’s formulation August 2039 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.November 2029Active
Orphan drug ODE-506Seven years of protection for a use in a rare disease.November 2031Active

Source: FDA Orange Book, application 216540. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Acoramidis Hydrochloride

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

No company is recorded as having applied to the FDA to make a generic Attruby yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic acoramidis hydrochloride. 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 acoramidis hydrochloride 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).

Attruby 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 Attruby, 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.

What Medicare and Medicaid Spend on Attruby

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 Attruby, before manufacturer rebates.

$214.1M
January to March 2026, the latest CMS has posted
For 4,160 people, about $20,332 per prescription fill
$405.7M
2025, the whole year
For 3,546 people, about $19,366 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$214,059,6534,160$20,332.41
2025$405,706,5913,546$19,366.39

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Attruby only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of heart failure (transthyretin-mediated amyloidosis). It is used to help prevent the heart failure from getting worse and needing treatment in a hospital.

Medicaid Prescriptions by Quarter

69 prescriptions in the four quarters to Q1 2026, $1.3M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202629$569,039
Q4 202515$281,534
Q3 202514$262,764
Q2 202511$206,456
Q1 20250$0

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

Attruby Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 356MG BASETabletOralNovember 2024Prescription reference product

Source: FDA Orange Book, Bridgebio Pharma Inc. Listed for sale today by BridgeBio Pharma, Inc. (FDA NDC Directory).

Attruby NDC Codes and Packages

Each Attruby 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.

Attruby packages (2)
NDCProductPackageCompany
82228-0712-28ACORAMIDIS HYDROCHLORIDE 356 mg/1 tablet, film coatedcarton of 4 dose packs of 1 blister pack of 28 tabletsBridgeBio Pharma, Inc.
82228-0712-30ACORAMIDIS HYDROCHLORIDE 356 mg/1 tablet, film coatedbottle of 120 tabletsBridgeBio Pharma, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Attruby’s own FDA approval (NDA 216540) are listed, never a generic. Some codes belong to companies that repackage Attruby: it is the same medicine in a different package.

What a Generic Attruby Means for You

Nothing Changes Until It Is in Pharmacies

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

Is there a generic for Attruby right now?

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

When will Attruby go generic?

March 2039 is the expected month, and that is toss-up but not certain. It is when Attruby’s patent 11,058,668 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to August 2039, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.

Will generic acoramidis hydrochloride be the same as Attruby?

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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.

Has the FDA approved a generic Attruby?

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

When does the Attruby patent expire?

The FDA Orange Book lists 13 patents for Attruby; the last runs to August 2039. The one behind the expected month is patent 11,058,668, which ends in March 2039. 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 (March 2039) weighs all of that.

Changes to This Projection

  • First generic expected March 2039 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 Attruby

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, 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.