MorphaBond ER Generic: When Will Generic Morphine 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

MorphaBond ER Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? TBD no date yet What opens the door is not settled yet
  2. Has the FDA approved a generic? July 1998 6 companies approved
  3. When does the last patent end? August 2028 2 patents listed with the FDA
  4. Can you buy a generic today? Yes 18 companies list one

Explains

PharmD, BCPS · Clinical pharmacist Updated

It already is. A generic morphine sulfate is listed for sale by 18 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 MorphaBond ER, 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.

MorphaBond ER 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 2015 October 2015 FDA Orange Book
  • Patents listed 2 last runs to August 2028 FDA Orange Book
  • Generics FDA-approved 6 companies, the first approved July 1998 FDA Orange Book

MorphaBond ER’s Road to a Generic

MorphaBond ER has had the market to itself since the FDA approved it in October 2015 (Ohemo Life Sciences Inc). Its 2 listed patents run to August 2028. Generic companies have challenged its patents with the FDA since January 2019.

The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

Brand alone on the market Since FDA approval, October 2015
Patent 7,955,619 Expires August 2028
Patent 10,314,788 Expires August 2028
Brand alone on the market Patent on the formulation Swipe the chart sideways to see every year.

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.

MorphaBond ER Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for MorphaBond ER’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.

Patents listed with the FDA (2)
PatentWhat it coversProtects untilStatus
7,955,619 The product’s formulation August 2028 Active
10,314,788 The product’s formulation August 2028 Active

Source: FDA Orange Book, application 206544. Patent numbers open the patent on Google Patents.

Patent Challenges to MorphaBond ER

The first patent challenge to MorphaBond ER reached the FDA in January 2019, from one company on that first day.

What Is a Patent Challenge?

A generic company that wants to sell its version before MorphaBond ER’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.

Patent challenges on the FDA’s list (1)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Extended-release tablets, 15 mg, 30 mg, 60 mg and 100 mg January 2019 1 company Not posted Not posted Not posted August 2028

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

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

At least 6 companies have applied to the FDA to make generic morphine sulfate.

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 MorphaBond ER’s patents with the FDA since January 2019: see the patent challenges.

2

Approved by the FDA

The FDA has approved generic versions from 6 companies, the first in July 1998. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic morphine sulfate is listed for sale by 18 companies. Ask your pharmacy whether it can fill your prescription with it.

Actavis Pharma, Inc., American Health Packaging, Amneal Pharmaceuticals of New York LLC, Bryant Ranch Prepack, Lupin Pharmaceuticals,Inc., Major Pharmaceuticals and 12 more

Generic versions the FDA has approved (17 companies)
CompanyFirst approvedStrengthsRated
Rhodes Pharmaceuticals LP July 199815MG, 30MG, 60MG, 100MG, 200MGAB
Dava Pharmaceuticals Inc January 200015MGAB
Specgx LLC July 200315MG, 30MG, 60MG, 100MG, 200MGAB
Sun Pharmaceutical Industries Ltd May 201215MG, 30MG, 60MG, 100MG, 200MGAB
Actavis Elizabeth LLC An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc January 201315MG, 30MG, 45MG, 60MG, 75MG, 90MG, 100MG, 120MG, 200MG–
Upsher Smith Laboratories LLC June 201310MG, 20MG, 30MG, 50MG, 60MG, 80MG, 100MG–
Strides Pharma International AG discontinued October 199815MG, 20MG, 30MG, 50MG, 60MG, 80MG, 100MG, 200MG–
Watson Laboratories Inc discontinued January 2001100MG–
Nesher Pharmaceuticals USA LLC discontinued May 200415MG, 30MG, 60MG, 100MG, 200MG–
Rising Pharma Holdings Inc discontinued October 201115MG, 30MG, 60MG, 100MG, 200MG–
Teva Pharmaceuticals USA discontinued December 201420MG, 30MG, 40MG, 50MG, 60MG, 70MG, 80MG, 100MG–
Novel Laboratories Inc discontinued December 201515MG, 30MG, 60MG, 100MG, 200MG–
Impax Laboratories Inc discontinued April 201620MG, 30MG, 40MG, 50MG, 60MG, 80MG, 100MG–
Epic Pharma LLC discontinued June 201615MG, 30MG, 60MG, 100MG, 200MG–
Sun Pharmaceutical Industries Inc discontinued August 201615MG, 30MG, 60MG, 100MG, 200MG–
Dr Reddys Laboratories SA discontinued October 201615MG, 30MG, 60MG, 100MG–
Anda Repository LLC discontinued August 202120MG, 30MG, 50MG, 60MG, 80MG, 100MG–

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).

MorphaBond ER 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 MorphaBond ER, 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.

MorphaBond ER Strengths and Forms

StrengthFormHow it is takenApprovedStatus
100MGTablet, extended releaseOralOctober 2015Discontinued reference product
15MGTablet, extended releaseOralOctober 2015Discontinued reference product
30MGTablet, extended releaseOralOctober 2015Discontinued reference product
60MGTablet, extended releaseOralOctober 2015Discontinued reference product

Source: FDA Orange Book, Ohemo Life Sciences Inc.

What a Generic MorphaBond ER 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 MorphaBond ER

Is there a generic for MorphaBond ER right now?

Yes. The FDA NDC Directory lists a generic morphine sulfate from 18 companies. Ask your pharmacy whether it can fill your prescription with it.

When will MorphaBond ER go generic?

It already has. The FDA NDC Directory lists a generic morphine sulfate from 18 companies, so ask your pharmacy whether it can fill your prescription with one.

Will generic morphine sulfate be the same as MorphaBond ER?

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. At least 6 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic MorphaBond ER?

Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in July 1998: Rhodes Pharmaceuticals LP, Dava Pharmaceuticals Inc, Specgx LLC, Sun Pharmaceutical Industries Ltd and 2 more. 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 MorphaBond ER patent expire?

The FDA Orange Book lists 2 patents for MorphaBond ER; the last runs to August 2028. 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 MorphaBond ER patents?

Yes. The first patent challenge to MorphaBond ER reached the FDA in January 2019, from one company on that first day. 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

All upcoming generics

About MorphaBond ER

  • Generic name morphine sulfate
  • How it is taken By mouth
  • Company Ohemo Life Sciences Inc
  • Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
  • Patent challenges Since January 2019 (FDA)
  • More drugs Brand-name drugs starting with M
  • Have a question? A pharmacist answers, free. Ask about MorphaBond ER

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.