Embeda Generic: When Will Generic Morphine and Naltrexone 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
Embeda 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? Not yet None in the FDA’s records yet
- When does the last patent end? November 2029 7 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic morphine sulfate and naltrexone hydrochloride. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Embeda 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.
Embeda by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2009 August 2009 FDA Orange Book
- Patents listed 7 last runs to November 2029 FDA Orange Book
Embeda’s Road to a Generic
Embeda has had the market to itself since the FDA approved it in August 2009 (Alpharma Pharmaceuticals LLC). Its 7 listed patents run to November 2029. Generic companies have challenged its patents with the FDA since May 2010.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Embeda Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Embeda’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 |
|---|---|---|---|
| 7,682,633 | A way of using it (U-1510) | June 2027 | Active |
| 7,682,634 | The product’s formulation | June 2027 | Active |
| 8,158,156 | A way of using it (U-1510) | June 2027 | Active |
| 8,846,104 | The product’s formulation | June 2027 | Active |
| 8,877,247 | The product’s formulation | June 2027 | Active |
| 7,815,934 | The product’s formulation | December 2027 | Active |
| 8,623,418 | A way of using it (U-1640) | November 2029 | Active |
Source: FDA Orange Book, application 022321. Patent numbers open the patent on Google Patents.
Patent Challenges to Embeda
The first patent challenge to Embeda reached the FDA in May 2010, from one company on that first day. The FDA’s list has 4 entries for Embeda, 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 Embeda’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.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Extended-release capsules, 100 mg/4 mg | May 2010 | 1 company | Head start no longer applies decided June 2020 | Not yet | Not yet | June 2027 |
| Extended-release capsules, 60 mg/2.4 mg | May 2010 | 1 company | Head start no longer applies decided June 2020 | Not yet | Not yet | June 2027 |
| Extended-release capsules, 30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg | May 2010 | 1 company | Head start no longer applies decided June 2020 | Not yet | Not yet | June 2027 |
| Extended-release capsules, 20 mg/0.8 mg | August 2018 | 1 company | Head start no longer applies decided February 2022 | Not yet | Not yet | November 2029 |
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 Morphine Sulfate and Naltrexone 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
One company has applied to the FDA to make generic morphine sulfate and naltrexone hydrochloride.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Embeda’s patents with the FDA since May 2010: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic morphine sulfate and naltrexone 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 morphine sulfate and naltrexone 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).
Embeda 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 Embeda, 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.
Embeda Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
| 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
| 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
| 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
| 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
| 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Capsule, extended release | Oral | August 2009 | Discontinued reference product |
Source: FDA Orange Book, Alpharma Pharmaceuticals LLC.
What a Generic Embeda Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Embeda 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 Embeda”. 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 Embeda
Is there a generic for Embeda right now?
No. As of October 9, 2026 no generic morphine sulfate and naltrexone hydrochloride is listed for sale in the FDA NDC Directory.
When will Embeda go generic?
There is no expected month yet. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic morphine sulfate and naltrexone hydrochloride be the same as Embeda?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Embeda?
Not yet. The FDA Orange Book lists no approved generic version of Embeda.
When does the Embeda patent expire?
The FDA Orange Book lists 7 patents for Embeda; the last runs to November 2029. 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.
Has anyone challenged the Embeda patents?
Yes. The first patent challenge to Embeda reached the FDA in May 2010, from one company 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.
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
- ZokinvyLonafarnibNovember 2027
- Tudorza PressairAclidinium BromideMarch 2029
- GocovriAmantadine HydrochlorideMarch 2030
- CibinqoAbrocitinibJanuary 2036
- MimryloRusfertide2037 to 2038
- QuviviqDaridorexant Hydrochloride2038 to 2039
About Embeda
- Generic name morphine sulfate and naltrexone hydrochloride
- How it is taken By mouth
- Company Alpharma Pharmaceuticals LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since May 2010 (FDA)
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Embeda
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.