Symproic Generic: When Will Generic Naldemedine 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
Symproic Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2031 About 4.5 years away 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? May 2033 5 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 naldemedine tosylate is expected to be available in February 2031, about 4.5 years away. None is for sale yet.
Why February 2031?
It is when Symproic’s patent RE46365 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Symproic’s last patent runs to May 2033, how can a generic come sooner?
The 3 patents that run past the expected month, to May 2033 (9,108,975, 10,952,968 and 12,350,377), cover the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier 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 Symproic 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.
Symproic by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $29M a yearSmaller seller
- FDA approved 2017 March 2017 FDA Orange Book
- Patents listed 5 last runs to May 2033 A generic is expected sooner, in February 2031. See why FDA Orange Book
- Pharmacies pay $16.26 per tablet, up 10% in a year NADAC, October 2026
- Medicare Part D spent $10.1M in 2025, for 4,178 people CMS Part D Spending by Drug
- Medicaid prescriptions 3,981 in the last four reported quarters, $1.9M CMS Medicaid drug utilization, to Q1 2026
Symproic’s Road to a Generic
Symproic has had the market to itself since the FDA approved it in March 2017 (Biodelivery Sciences International Inc). Its 5 listed patents run to May 2033 (1 already expired).
The first generic of Symproic is expected in February 2031.
Why that month: patent RE46365, on the active ingredient and the product’s formulation, ends then. That is about 2 years before the last listed patent runs out, in May 2033.
Why a Generic Can Come Before May 2033
The last listed patent runs to May 2033; a court ruling or a settlement can bring a generic sooner. 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.
Symproic Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Symproic’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 RE46365, which ends in February 2031, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| RE46375 | The active ingredient; the product’s formulation; a way of using it (U-1185) | October 2026 | Expired |
| RE46365 Sets the expected month of generic availability | The active ingredient; the product’s formulation | February 2031 | Active |
| 9,108,975 | The active ingredient; the product’s formulation | November 2031 | Active |
| 10,952,968 | The active ingredient; the product’s formulation | May 2033 | Active |
| 12,350,377 | The product’s formulation | May 2033 | Active |
Source: FDA Orange Book, application 208854. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Naldemedine Tosylate
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 Symproic yet.
Approved by the FDA
Not yet. The FDA has not approved a generic naldemedine tosylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic naldemedine tosylate 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).
Symproic Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Symproic 0.2 mg tablet
$16.26 per tablet in October 2026, up 10% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $16.26 |
| September 2026 | $16.26 |
| August 2026 | $16.25 |
| July 2026 | $16.25 |
| June 2026 | $16.25 |
| May 2026 | $16.24 |
| April 2026 | $16.28 |
| March 2026 | $16.28 |
| February 2026 | $16.28 |
| January 2026 | $16.28 |
| February 2024 | $14.77 |
| January 2024 | $14.77 |
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
How we estimate it. We start from what pharmacies pay for Symproic today: $16.26 per tablet for Symproic 0.2 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).
Dollar figures apply FDA’s median drops to the $16.26 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 Symproic
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 Symproic, before manufacturer rebates.
- $2.2M
- January to March 2026, the latest CMS has posted
For 2,200 people, about $571 per prescription fill - $10.1M
- 2025, the whole year
For 4,178 people, about $545 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,226,751 | 2,200 | $571.11 |
| 2025 | $10,114,727 | 4,178 | $545.27 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Symproic only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain.
Medicaid Prescriptions by Quarter
3,981 prescriptions in the four quarters to Q1 2026, $1.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 937 | $470,947 |
| Q4 2025 | 976 | $469,964 |
| Q3 2025 | 1,028 | $490,392 |
| Q2 2025 | 1,040 | $493,169 |
| Q1 2025 | 1,134 | $540,275 |
Source: CMS Medicaid State Drug Utilization Data, over Symproic’s own package codes.
Symproic Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.2MG BASE | Tablet | Oral | March 2017 | Prescription reference product |
Source: FDA Orange Book, Biodelivery Sciences International Inc. Listed for sale today by BioDelivery Sciences International Inc (FDA NDC Directory).
Symproic NDC Codes and Packages
Each Symproic 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 |
|---|---|---|---|
| 59385-0041-07 | NALDEMEDINE TOSYLATE .2 mg/1 tablet | blister pack of 7 tablets | BioDelivery Sciences International Inc |
| 59385-0041-30 | NALDEMEDINE TOSYLATE .2 mg/1 tablet | bottle of 30 tablets | BioDelivery Sciences International Inc |
| 59385-0041-30 | NALDEMEDINE TOSYLATE .2 mg/1 tablet | bottle of 30 tablets | BioDelivery Sciences International Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Symproic’s own FDA approval (NDA 208854) are listed, never a generic. Some codes belong to companies that repackage Symproic: it is the same medicine in a different package.
What a Generic Symproic Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Symproic 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 Symproic”. 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 Symproic
Is there a generic for Symproic right now?
No. As of October 9, 2026 no generic naldemedine tosylate is listed for sale in the FDA NDC Directory.
When will Symproic go generic?
February 2031 is the expected month, and that is probable but not certain. It is when Symproic’s patent RE46365 ends. That patent covers the active ingredient and the product’s formulation, 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 May 2033; a court ruling or a settlement can bring a generic sooner.
Will generic naldemedine tosylate be the same as Symproic?
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 Symproic?
Not yet. The FDA Orange Book lists no approved generic version of Symproic.
When does the Symproic patent expire?
The FDA Orange Book lists 5 patents for Symproic; the last runs to May 2033. The one behind the expected month is patent RE46365, which ends in February 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 (February 2031) weighs all of that.
How much does Symproic cost now?
Pharmacies paid about $16.26 per tablet for Symproic 0.2 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 February 2031 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
- NayzilamMidazolamJanuary 2028
- DaklinzaDaclatasvir DihydrochlorideJuly 2029
- RezlidhiaOlutasidenib2037 to 2038
- IheezoChloroprocaineMay 2039
- ActharCorticotropinTBD no date yet
- ValturnaAliskiren Hemifumarate and ValsartanTBD no date yet
About Symproic
- Generic name naldemedine tosylate
- How it is taken By mouth
- Company Biodelivery Sciences International Inc
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Symproic
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, 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.