Olpruva Generic: When Will Generic Sodium Phenylbutyrate 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
Olpruva 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? November 2011 3 companies approved
- When does the last patent end? October 2036 3 patents listed with the FDA
- Can you buy a generic today? Yes 6 companies list one
It already is. A generic sodium phenylbutyrate is listed for sale by 6 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Olpruva, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Olpruva by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2022 December 2022 FDA Orange Book
- Patents listed 3 last runs to October 2036 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved November 2011 FDA Orange Book
- Medicare Part D spent $573.8K in 2025 CMS Part D Spending by Drug
Olpruva’s Road to a Generic
Olpruva has had the market to itself since the FDA approved it in December 2022 (Acer Therapeutics Inc). Its 3 listed patents run to October 2036.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
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.
Olpruva Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Olpruva’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 |
|---|---|---|---|
| 11,154,521 | The product’s formulation | October 2036 | Active |
| 11,202,767 | A way of using it (U-3502) | October 2036 | Active |
| 11,433,041 | The product’s formulation | October 2036 | Active |
Source: FDA Orange Book, application 214860. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Sodium Phenylbutyrate
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 application count is on record for Olpruva, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in November 2011. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic sodium phenylbutyrate is listed for sale by 6 companies. Ask your pharmacy whether it can fill your prescription with it.
GLENMARK PHARMACEUTICALS INC., USA, Navinta LLC, Par Health USA, LLC, Par Pharmaceutical, Inc., Sigmapharm Laboratories, LLC and Zydus Pharmaceuticals USA Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Ph Health Ltd | April 2016 | 3GM/TEASPOONFUL, 500MG | AB |
| Glenmark Pharmaceuticals Ltd | November 2022 | 500MG | AB |
| Navinta LLC | February 2026 | 500MG | AB |
| Alvogen Inc discontinued | November 2011 | 500MG | – |
| Sigmapharm Laboratories LLC discontinued | March 2013 | 3GM/TEASPOONFUL | – |
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).
Olpruva 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 Olpruva, 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 Olpruva
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 Olpruva, before manufacturer rebates.
- $573.8K
- 2025, the whole year
About $44,139 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $573,804 | – | $44,138.80 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Olpruva only, so no generic is counted in it. What CMS says it is used for: This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). Sodium phenylbutyrate helps remove a certain chemical (ammonia) from the body.
Olpruva Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 3GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 4GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 5GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 6.67GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 6GM/PACKET | For suspension | Oral | December 2022 | Prescription reference product |
| 0.5GM/PACKET | For suspension | Oral | October 2025 | Prescription reference product |
| 1GM/PACKET | For suspension | Oral | October 2025 | Prescription reference product |
Source: FDA Orange Book, Acer Therapeutics Inc. Listed for sale today by Acer Therapeutics Inc. (FDA NDC Directory).
Olpruva NDC Codes and Packages
Each Olpruva 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 |
|---|---|---|---|
| 72542-0200-09 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0200-09 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0300-09 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0300-09 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0400-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0400-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0500-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0500-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
Show the other 4 Olpruva packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 72542-0600-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0600-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0667-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
| 72542-0667-18 | kit | 90 BOX in 1 CARTON / 1 KIT in 1 BOX * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET * 1 FOR SUSPENSION in 1 PACKET | Acer Therapeutics Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Olpruva’s own FDA approval (NDA 214860) are listed, never a generic. Some codes belong to companies that repackage Olpruva: it is the same medicine in a different package.
What a Generic Olpruva Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Olpruva
Is there a generic for Olpruva right now?
Yes. The FDA NDC Directory lists a generic sodium phenylbutyrate from 6 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Olpruva go generic?
It already has. The FDA NDC Directory lists a generic sodium phenylbutyrate from 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic sodium phenylbutyrate be the same as Olpruva?
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. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Olpruva?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in November 2011: Ph Health Ltd, Glenmark Pharmaceuticals Ltd and Navinta LLC. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Olpruva patent expire?
The FDA Orange Book lists 3 patents for Olpruva; the last runs to October 2036. 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.
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
- LutatheraLutetium Lu 177 Dotatate2026 to 2027
- TriumeqAbacavir Sulfate, Dolutegravir Sodium, and LamivudineDuring 2028
- ZeposiaOzanimod Hydrochloride2033 to 2034
- CamzyosMavacamtenApril 2036
- QalsodyTofersen2038 to 2039
- GeNOsylNitric OxideJuly 2040
About Olpruva
- Generic name sodium phenylbutyrate
- How it is taken By mouth
- Company Acer Therapeutics Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Olpruva
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.