Palsonify Generic: When Will Generic Paltusotine 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
Palsonify Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2041 to 2042 A wide window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? March 2044 9 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic paltusotine hydrochloride is expected to be available between 2041 and 2042. None is for sale yet.
Why 2041 to 2042?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Palsonify’s last patent runs to March 2044, how can a generic come sooner?
The patent that runs to March 2044 (12,208,092) covers 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. Here, the companies are expected to settle on a date. 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 Palsonify 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.
Palsonify by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- 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
- Sales not reported
- FDA approved 2025 September 2025 FDA Orange Book
- Patents listed 9 last runs to March 2044 A generic is expected sooner, between 2041 and 2042. See why FDA Orange Book
- Medicare Part D spent $1.1M in 2025, for 30 people CMS Part D Spending by Drug
Palsonify’s Road to a Generic
Palsonify has had the market to itself since the FDA approved it in September 2025 (Crinetics Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to September 2032. Its 9 listed patents run to March 2044.
The first generic of Palsonify is expected between 2041 and 2042.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before March 2044
The last listed patent runs to March 2044, but it covers 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.
Palsonify Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Palsonify’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 |
|---|---|---|---|
| 9,896,432 | The active ingredient; the product’s formulation; a way of using it (U-4283) | July 2037 | Active |
| 10,351,547 | The active ingredient; the product’s formulation; a way of using it (U-4283) | July 2037 | Active |
| 10,597,377 | The active ingredient; the product’s formulation; a way of using it (U-4283) | July 2037 | Active |
| 10,875,839 | A way of using it (U-4283) | July 2037 | Active |
| 11,414,397 | The active ingredient; the product’s formulation; a way of using it (U-4283) | July 2037 | Active |
| 10,464,918 | The active ingredient | January 2039 | Active |
| 11,266,641 | The product’s formulation; a way of using it (U-4283) | September 2041 | Active |
| 11,957,674 | A way of using it (U-4283) | September 2041 | Active |
| 12,208,092 | A way of using it (U-4282) | March 2044 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | September 2030 | Active |
| Orphan drug ODE-537 | Seven years of protection for a use in a rare disease. | September 2032 | Active |
Source: FDA Orange Book, application 219070. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Paltusotine 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.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Palsonify yet.
Approved by the FDA
Not yet. The FDA has not approved a generic paltusotine hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic paltusotine 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).
Palsonify 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 Palsonify, 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 Palsonify
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 Palsonify, before manufacturer rebates.
- $3.8M
- January to March 2026, the latest CMS has posted
For 83 people, about $23,576 per prescription fill - $1.1M
- 2025, the whole year
For 30 people, about $23,695 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $3,795,708 | 83 | $23,575.82 |
| 2025 | $1,066,271 | 30 | $23,694.90 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Palsonify only, so no generic is counted in it. What CMS says it is used for: Paltusotine is used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease.
Palsonify Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE | Tablet | Oral | September 2025 | Prescription reference product |
| EQ 30MG BASE | Tablet | Oral | September 2025 | Prescription reference product |
Source: FDA Orange Book, Crinetics Pharmaceuticals Inc. Listed for sale today by Crinetics Pharmaceuticals, Inc. (FDA NDC Directory).
Palsonify NDC Codes and Packages
Each Palsonify 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.
| NDC | Product | Package | Company |
|---|---|---|---|
| 84015-0920-60 | PALTUSOTINE HYDROCHLORIDE 20 mg/1 tablet, film coated | bottle of 60 tablets | Crinetics Pharmaceuticals, Inc. |
| 84015-0930-60 | PALTUSOTINE HYDROCHLORIDE 30 mg/1 tablet, film coated | bottle of 60 tablets | Crinetics Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Palsonify’s own FDA approval (NDA 219070) are listed, never a generic. Some codes belong to companies that repackage Palsonify: it is the same medicine in a different package.
What a Generic Palsonify Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Palsonify 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 Palsonify”. 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 Palsonify
Is there a generic for Palsonify right now?
No. As of October 9, 2026 no generic paltusotine hydrochloride is listed for sale in the FDA NDC Directory.
When will Palsonify go generic?
2041 to 2042 is the expected window, and that is toss-up but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to March 2044, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic paltusotine hydrochloride be the same as Palsonify?
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 Palsonify?
Not yet. The FDA Orange Book lists no approved generic version of Palsonify.
When does the Palsonify patent expire?
The FDA Orange Book lists 9 patents for Palsonify; the last runs to March 2044. 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 (2041 to 2042) weighs all of that.
Changes to This Projection
- First generic expected 2041 to 2042 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
- NevanacNepafenacJanuary 2027
- VemlidyTenofovir Alafenamide FumarateOctober 2031
- RiViveNaloxone HydrochlorideMay 2032
- DefencathHeparin Sodium and TaurolidineJuly to December 2035
- ImmphentivPhenylephrine HydrochlorideSeptember 2036
- AdlarityDonepezilAugust 2038
About Palsonify
- Generic name paltusotine hydrochloride
- How it is taken By mouth
- Company Crinetics Pharmaceuticals Inc
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Palsonify
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.