EMBEDA Drug Patent Profile

When do Embeda patents expire, and what generic alternatives are available?

Embeda is a drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Embeda

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2027. This may change due to patent challenges or generic licensing.

There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for EMBEDA

International Patents:	74
US Patents:	9
Applicants:	1
NDAs:	1
Clinical Trials:	7
Drug Prices:	Drug price information for EMBEDA
What excipients (inactive ingredients) are in EMBEDA?	EMBEDA excipients list
DailyMed Link:	EMBEDA at DailyMed

See drug prices for EMBEDA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EMBEDA

Constraining patent/regulatory exclusivity:

8,846,104

NDA:

022321

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EMBEDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 1
Pfizer	Phase 4
Pfizer	Phase 3

See all EMBEDA clinical trials

Paragraph IV (Patent) Challenges for EMBEDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	20 mg/0.8 mg	022321	1	2018-08-16
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg	022321	1	2010-05-28
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	60 mg/2.4 mg	022321	1	2010-05-25
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	100 mg/4 mg	022321	1	2010-05-03

US Patents and Regulatory Information for EMBEDA

EMBEDA is protected by nine US patents.

This potential generic entry date is based on patent 8,846,104.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No	8,685,444		Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No	8,846,104		Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No	7,682,633

Expired US Patents for EMBEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	5,378,474

International Patents for EMBEDA

When does loss-of-exclusivity occur for EMBEDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EMBEDA around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2719378
South Korea	20140079441	PHARMACEUTICAL COMPOSITIONS
European Patent Office	2484346	Compositions pharmaceutiques (Pharmaceutical compositions)

EMBEDA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug Embeda

Introduction

Embeda, a drug developed by Pfizer, is an extended-release opioid analgesic designed to manage severe pain that requires around-the-clock treatment. The drug combines morphine sulfate, a full opioid agonist, with naltrexone hydrochloride, an opioid antagonist. Here, we delve into the market dynamics and financial trajectory of Embeda, from its approval to its eventual discontinuation.

Approval and Initial Market Entry

Embeda was first approved by the FDA in 2009 as one of the earlier attempts to produce an abuse-deterrent opioid. The drug was intended to reduce the abuse liability associated with opioids by incorporating naltrexone, which would be released if the tablet was crushed or chewed, thereby deterring misuse[1][4].

Initial Challenges and Recall

Despite its innovative formulation, Embeda faced significant challenges early on. In 2011, Pfizer voluntarily recalled Embeda due to stability issues in the manufacturing process. This recall marked the first major setback for the drug, impacting its market presence and patient trust[1][3].

Reintroduction and Market Performance

After addressing the manufacturing issues, Embeda was reintroduced to the market in 2015. However, it never gained substantial market traction compared to other long-acting opioids like OxyContin. The drug's popularity remained limited, partly due to the availability of alternative opioids and the lack of a significant reduction in abuse liability as claimed by the naltrexone component[1].

Abuse-Deterrent Properties and Labeling

In 2013, the FDA issued draft guidance on abuse-deterrent opioids, and Embeda was one of the first drugs to be approved with labeling describing its abuse-deterrent properties. The new labeling included claims that Embeda had properties expected to reduce oral and intranasal abuse when the product was crushed. Despite this, the package insert noted that naltrexone in Embeda had not been shown to reduce the product’s overall abuse liability[4].

Financial Impact and Market Position

The financial impact of Embeda on Pfizer's portfolio was minimal due to its limited market success. The drug did not contribute significantly to Pfizer's revenue, especially when compared to other successful opioid products. The lack of market dominance and the presence of alternative treatments meant that Embeda's discontinuation would have a relatively minor impact on both patients and the pharmaceutical market[1].

Discontinuation and Transition

In 2019, Pfizer announced the discontinuation of Embeda, with the FDA posting a "stop sale date" of November 15, 2019. The decision marked the second time Embeda was voluntarily withdrawn from the market. Patients were advised to transition to alternative long-acting morphine products such as Kadian, MS Contin, Arymo ER, and MorphaBond ER. This transition was facilitated by dispensing pharmacies, which played a crucial role in informing patients and providing counseling on alternative medications[1].

Reasons for Discontinuation

While Pfizer did not release an official statement on the reasons for discontinuing Embeda, the history of stability issues and the drug's limited market impact are significant factors. The FDA's previous actions on other abuse-deterrent opioids for safety reasons did not appear to be a factor in this case[1].

Market Alternatives and Patient Impact

The discontinuation of Embeda led to a need for patients to switch to alternative medications. The closest alternatives were other long-acting morphine products, both generic and brand-only abuse-deterrent formulations. This transition was expected to be smooth, given the availability of these alternatives and the minimal market presence of Embeda[1].

Financial Trajectory

From a financial perspective, the discontinuation of Embeda had a negligible impact on Pfizer's overall revenue. The drug's limited market success and the presence of more popular alternatives meant that its removal did not significantly affect Pfizer's financial trajectory. The transition to other medications was expected to result in some cost adjustments for patients, but these were not anticipated to be substantial[1].

Industry Perspective

The story of Embeda highlights the challenges faced by pharmaceutical companies in developing and maintaining market presence for abuse-deterrent opioids. Despite innovative formulations, drugs like Embeda often face significant hurdles, including manufacturing issues, regulatory scrutiny, and competition from established products. This case underscores the importance of robust market research, manufacturing stability, and regulatory compliance in the pharmaceutical industry.

Key Takeaways

• Approval and Challenges: Embeda was approved in 2009 but faced immediate challenges, including a recall in 2011 due to manufacturing stability issues.
• Limited Market Success: Despite its reintroduction in 2015, Embeda never gained significant market traction.
• Abuse-Deterrent Properties: Embeda was one of the first drugs to be approved with labeling describing its abuse-deterrent properties, but it did not significantly reduce abuse liability.
• Discontinuation: The drug was discontinued in 2019 due to its limited market impact and historical stability issues.
• Transition to Alternatives: Patients were transitioned to other long-acting morphine products, both generic and brand-only formulations.

FAQs

1. Why was Embeda initially recalled in 2011? Embeda was initially recalled in 2011 due to stability issues in the manufacturing process.

2. What is the unique formulation of Embeda? Embeda combines an extended-release formulation of morphine sulfate with naltrexone hydrochloride, designed to deter abuse by releasing naltrexone if the tablet is crushed or chewed.

3. Why did Embeda fail to gain significant market traction? Embeda failed to gain significant market traction due to its limited effectiveness in reducing abuse liability and the presence of more popular alternative opioids.

4. What alternatives are available for patients transitioning from Embeda? Patients can transition to other long-acting morphine products such as Kadian, MS Contin, Arymo ER, and MorphaBond ER.

5. What was the financial impact of Embeda's discontinuation on Pfizer? The financial impact of Embeda's discontinuation on Pfizer was minimal due to the drug's limited market success and revenue contribution.

Cited Sources:

1. Pfizer's Opioid Embeda to Be Discontinued - myMatrixx
2. Overdose Prevention Activities Timeline - FDA
3. DRUG PRICING IN AMERICA: A PRESCRIPTION FOR CHANGE - govinfo.gov
4. Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose - FDA