EXALGO Drug Patent Profile

Which patents cover Exalgo, and when can generic versions of Exalgo launch?

Exalgo is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Exalgo

A generic version of EXALGO was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for EXALGO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	2,124
Drug Prices:	Drug price information for EXALGO
What excipients (inactive ingredients) are in EXALGO?	EXALGO excipients list
DailyMed Link:	EXALGO at DailyMed

See drug prices for EXALGO

See drug sales revenues for EXALGO

Recent Clinical Trials for EXALGO

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

Sponsor	Phase
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1
M.D. Anderson Cancer Center	Phase 3

See all EXALGO clinical trials

Paragraph IV (Patent) Challenges for EXALGO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	8 mg and 12 mg	021217	1	2010-09-02
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	16 mg	021217	1	2010-08-02

US Patents and Regulatory Information for EXALGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010		DISCN	Yes	No

Expired US Patents for EXALGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010

International Patents for EXALGO

See the table below for patents covering EXALGO around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1025845
Spain	2186302
Austria	227575
Denmark	0769949
Spain	2186724
New Zealand	289289	HYDROMORPHONE (4,5-EPOXY-3-HYDROXY-17-METHYLMORPHINAN-6-ONE) COMPOSITIONS AND USE THEREOF
European Patent Office	0769949	THERAPIE AUX HYDROMORPHONES (HYDROMORPHONE THERAPY)

Market Dynamics and Financial Trajectory for Exalgo

Last updated: July 27, 2025

Introduction

Exalgo, marketed by Mallinckrodt Pharmaceuticals, is a prescription extended-release opioid analgesic primarily containing hydromorphone. Approved by the U.S. Food and Drug Administration (FDA) in 2010, Exalgo was developed to provide sustained pain relief for patients with severe pain requiring around-the-clock opioid management. Its market performance, competitive landscape, and regulatory environment are central to understanding its financial trajectory and future market dynamics.

Market Dynamics

1. Industry Context and Growing Demand for Opioid Analgesics

The global opioid analgesics market experienced substantial growth over the past decade, driven by rising incidences of chronic pain conditions and improved diagnosis. In 2021, the global opioid analgesics market was valued at approximately USD 20 billion, with projections to reach USD 25–30 billion by 2028, reflecting a compound annual growth rate (CAGR) of around 4–5%[1]. The United States remains the dominant market, owing to high prescribing rates and healthcare system characteristics.

2. Exalgo’s Positioning and Market Penetration

Exalgo's formulation offers a once-daily oral administration with a controlled-release system, aiming to provide sustained analgesia and reduce dosing frequency. Its unique delivery mechanism distinguishes it from immediate-release hydromorphone formulations and other opioids like oxycodone or morphine. However, despite these advantages, Exalgo faces challenges such as:

• Market penetration limitations: Due to competition from generics and other long-acting opioids.
• Prescribing habits: Growing emphasis on prudent opioid prescribing due to the opioid epidemic.
• Regulatory scrutiny: Increased oversight, prescribing restrictions, and monitoring programs.

3. Competitive Landscape

Exalgo’s primary competitors include other long-acting opioids such as OxyContin (oxycodone ER), MS Contin (morphine ER), and newer formulations like Xtampza ER. The market has also seen a surge in abuse-deterrent formulations, influencing prescriber preferences. Generic versions of hydromorphone ER are available, exerting significant price and market share pressure on branded formulations like Exalgo.

4. Regulatory and Societal Influences

The opioid crisis has reshaped the regulatory landscape. The CDC’s 2016 guidelines on opioid prescribing emphasize caution, especially for chronic non-malignant pain. This has led to:

• Reduced prescriptions: Data indicates a decline in opioid prescribing volume post-2016.
• Increased monitoring: Use of Prescription Drug Monitoring Programs (PDMPs).
• Legal and reputational risks: Manufacturers face litigation and negative publicity, impacting sales.

5. Pricing and Reimbursement

Exalgo’s pricing premium over generic hydromorphone ER is relatively modest but remains a factor. Reimbursement policies vary across payers, and patients increasingly face high co-pays for branded opioids. These factors constrain market share expansion and influence overall revenue.

Financial Trajectory

1. Revenue Trends

Since its launch in 2010, Exalgo initially captured a niche segment among pain specialists. However, over the past decade, sales have declined proportionally with the broader opioid market contraction. The decline correlates with increased regulatory scrutiny, the availability of cheaper generics, and shifts towards multimodal pain management strategies.

Year-over-year data indicate a downward trend in exalgo’s sales. For instance, Mallinckrodt’s 2020 financial report marked a sharp decrease in opioid-related revenues—excluding Exalgo, the company reported a 20% decline in opioid sales overall[2]. Although specific Exalgo sales figures are proprietary, industry estimates suggest annual sales have decreased by approximately 10–15% since peaking around 2015.

2. Impact of Patent and Legal Risks

Exalgo’s patent protections have lapsed or faced challenges, leading to faster generic entry. The entrance of multiple hydromorphone ER generics has eroded branded revenue streams. Additionally, the ongoing opioid litigation landscape poses financial risks, including potential penalties or settlement costs, influencing long-term revenue estimates.

3. Strategic Response and Future Outlook

Mallinckrodt has employed strategies such as promoting alternative pain management products and emphasizing their specialty pharmaceuticals portfolio. However, given the societal push for reduced opioid use, expectations for meaningful growth in Exalgo's revenues are subdued. The current trend suggests continued decline barring significant market or regulatory shifts.

Future Market Dynamics

1. Market Contraction and Regulatory Environment

The overall opioid market is contracting in many regions, especially in the US, due to tightening regulations. This trend constrains Exalgo's potential revenue growth, turning the product more into a legacy asset rather than a growth driver.

2. Emerging Pain Management Modalities

The rise of non-opioid alternatives, such as nerve blocks, neuromodulation, and non-addictive analgesics, further diminishes the market for opioids like Exalgo. These innovations, coupled with legislative restrictions, are shifting the pharmaceutical landscape.

3. Impact of Abuse-Deterrent Formulations and Legal Climate

While abuse-deterrent formulations are relevant, their adoption in Exalgo has been limited compared to other opioids. The legal environment, marked by large-scale litigations against opioid manufacturers, imposes financial and reputational risks that likely will constrain future market activity.

4. Potential for Niche and Specialty Use

Despite challenges, Exalgo may retain niche use in severe, controlled clinical settings where prolonged, predictable pain management is critical. Its role in such settings will depend on clinician preferences, formulary decisions, and regulatory guidance.

Conclusion

Exalgo's market dynamics are characterized by a contraction amid societal efforts to curb opioid misuse, intense competition from generics, and ongoing legal considerations. Its financial trajectory over the next five years is expected to remain subdued, with incremental declines unless market or regulatory factors shift significantly. The overall environment underscores the importance of diversification and innovation in pharmaceutical portfolios.

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Key Takeaways

• Exalgo's market share has declined due to generic competition, regulatory constraints, and societal shifts away from opioids.
• Revenue projections indicate continued decline; the product is unlikely to regain growth without market or regulatory pivots.
• The opioid epidemic and associated legal actions pose both operational and financial risks for Exalgo.
• Market adaptations favor non-opioid pain treatments, further limiting the long-term prospects of Exalgo.
• Stakeholders should focus on niche applications or therapeutic areas with less regulatory and societal scrutiny.

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FAQs

1. What factors have led to Exalgo's declining sales?
Market contraction driven by increased generic competition, regulatory restrictions on opioid prescriptions, societal efforts to combat opioid misuse, and legal challenges have significantly curtailed Exalgo’s sales.

2. How does regulatory scrutiny impact the future of Exalgo?
Stringent prescribing guidelines and potential litigation risks discourage widespread use, consequently limiting market growth and revenue prospects for Exalgo.

3. Are there any recent developments or innovations related to Exalog?
There have been no significant recent innovations specific to Exalgo. The focus has shifted toward alternative pain management approaches amid the broader opioid crisis.

4. What is the outlook for Exalgo in niche clinical settings?
In specialized, controlled clinical environments, Exalgo may retain limited utility, but its broader market presence is unlikely to expand unless societal and regulatory landscapes change.

5. Could legal proceedings against opioid manufacturers influence Exalgo's market?
Yes, ongoing litigation and large settlements against opioid makers could impose financial liabilities or restrict product marketing, affecting Exalgo’s market stability.

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References

[1] MarketsandMarkets. "Opioid analgesics market," 2022.
[2] Mallinckrodt Pharmaceuticals. Annual Financial Reports, 2020.