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. Seventeen 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	5,914,131
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010	5,702,725
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010	5,702,725
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010	5,914,131

International Patents for EXALGO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9601629
Portugal	1025845
New Zealand	289289	HYDROMORPHONE (4,5-EPOXY-3-HYDROXY-17-METHYLMORPHINAN-6-ONE) COMPOSITIONS AND USE THEREOF
Spain	2186724

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EXALGO

Last updated: December 25, 2025

Executive Summary

Exalgo (hydromorphone HCl) is a potent opioid analgesic indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Since its FDA approval in 2010, Exalgo's market trajectory has been shaped by evolving regulatory landscapes, opioid prescribing trends, competitive dynamics, and societal concerns surrounding opioid use. This analysis provides a comprehensive overview of the current market environment, key financial indicators, competitive positioning, regulatory influences, and future outlook for Exalgo.

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What Are the Key Market Drivers Influencing Exalgo's Commercial Viability?

Growing and Changing Opioid Prescribing Practices

• Shift Towards Multimodal Pain Management: Healthcare providers increasingly adopt multimodal strategies, reducing reliance on opioids owing to growing awareness of addiction risks.
• Regulatory Crackdowns: Agencies like the CDC have implemented stricter guidelines, impacting opioid prescriptions and thereby influencing sales of drugs like Exalgo.
• Opioid Epidemic and Societal Input: Heightened scrutiny regarding opioid misuse and abuse has resulted in decreased prescription volumes for opioid analgesics, impacting revenue prospects.

Market Size and Demand Dynamics

Market Segment	Size (USD, 2022)	CAGR (2018-2022)	Drivers	Limitations
Chronic Pain Market	$76B	3.5%	Aging populations, sedentary lifestyles	Stricter regulation, alternative therapies
Specialty Pain Clinics	Elevated prescription rates			Emphasis on non-opioid treatments
Hospital Utilization	Steady demand			Focus on opioid stewardship programs

Note: The overall opioid analgesics market was valued at approximately $13.4 billion in 2022 globally, with opioids accounting for a significant share in pain management therapeutics[1].

Competitive Landscape

Competitor	Key Products	Market Share (Approximate, 2022)	Unique Selling Points
Purdue Pharma (OxyContin)	Oxycodone ER	28%	Long-acting formulations, established brand
Cephalon (Fentalog)	Fentanyl patches	15%	Potent, transdermal delivery
Mallinckrodt	Butrans, Exalgo	10% (Exalgo’s segment)	Extended-release formulations

Exalgo's position is primarily in the extended-release hydromorphone segment, representing approximately 10% of the market share.

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What Are the Financial Trends for Exalgo?

Sales and Revenue Trajectory

Year	Estimated Sales (USD millions)	Notes
2011	$120M	Launch year, rapid uptake
2015	$90M	Market saturation, regulatory impact
2020	$45M	Significant decline, opioid scrutiny
2022	$38M	Stabilization at lower revenue levels

The trend indicates a significant decline (~68%) since launch, primarily due to regulatory restrictions, decreased prescriber confidence, and market saturation.

Profitability and Cost Factors

• Manufacturing Costs: Higher due to specialized extended-release drug formulations.
• Marketing Expenditure: Declined over recent years as sales plateaued.
• Legal and Litigation Liabilities: Potential for continued legal risks, increasing overall costs.

Pricing Dynamics

Pricing Aspect	Details	Impact
Average Wholesale Price (AWP)	~$42 per 20 mg tablet (2011)	High initial pricing, declined by ~15% by 2022
Reimbursement Rates	Vary by insurer; narrower coverage	Pressure on profit margins

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How Do Regulatory Policies Shape Exalgo’s Market and Financial Outlook?

Policy/Guideline	Impact on Exalgo	Notable Dates	Authority
CDC Guideline for Prescribing Opioids (2016)	Reduced prescribing	2016	CDC
FDA REMS Program (2012)	Enhanced opioid safety protocols	2012	FDA
State-level Prescription Drug Monitoring Programs (PDMPs)	Stricter oversight	Ongoing	State agencies

Implications for Exalgo:

• Elevated barriers to prescribing leading to decreased volume.
• Increased operational costs to comply with REMS.
• Heightened scrutiny limits aggressive marketing strategies.

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What Is the Future Outlook for Exalgo?

Market Penetration and Growth Opportunities

Opportunities	Details	Challenges
Niche Use in Cancer or Palliative Care	Targeted, short-term applications	Limited overall demand
Alternative Delivery Systems	Innovate formulations (e.g., implants)	R&D costs and regulatory approval hurdles
Regulatory Flexibilities	Advocacy for expanded indications	Risk of non-approval

Pipeline and Innovation

• Generic Competition: Several patents have expired, leading to increased generic availability, compressing profit margins.
• Potential Alternatives: Development of abuse-deterrent formulations or combination therapies can influence future competitiveness.

Forecast Summary

Year	Projected Sales (USD)	Assumptions	Risks
2023	$35M	Continued market saturation	Legal risks, regulatory changes
2025	$20M	Shrinking demand	Increased generics, societal shifts
2030	$10M	Possible niche market maintenance	Obsolete, replaced by non-opioid therapies

Exalgo’s future hinges on societal attitudes toward opioids, regulatory adjustments, and innovation trajectories.

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Comparison With Similar Extended-Release Opioids

Drug	Release Type	Indications	Market Share (2022)	Price per 20 mg dose	Regulatory Status
Exalgo	Hydromorphone ER	Severe pain	~10%	$1.50	REMS, post-approval safety restrictions
OxyContin	Oxycodone ER	Severe pain	28%	$1.80	Well-established, regulatory scrutiny
Duragesic	Fentanyl patch	Chronic pain	15%	Varies	Strict prescribing limits

Observation: Exalgo's positioning centralizes in niche markets, with overall declining market share amid competition and regulation.

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Key Takeaways

• Market decline is ongoing: Exalgo faces diminishing revenue due to increased regulation, societal concerns, and competition from generics.
• Regulatory environment is pivotal: Stricter prescribing guidelines and REMS impose barriers, limiting growth prospects.
• Innovation opportunities are limited: Advancements focus on abuse-deterrent formulations; however, cost and regulatory challenges prevail.
• Niche positioning offers potential: Focus on specific patient populations, like palliative care, might sustain residual demand.
• Strategic pivot needed: Manufacturers should consider diversification into non-opioid analgesics or alternative pain management modalities.

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Frequently Asked Questions (FAQs)

Q1: What factors led to the decline in Exalgo’s sales since launch?
A: Key drivers include intensified regulatory scrutiny, societal backlash against opioids fueled by the opioid epidemic, competition from generic formulations, and prescriber hesitance.

Q2: How do regulatory policies impact Exalgo’s profitability?
A: Policies like CDC guidelines and FDA REMS impose prescribing and distribution restrictions that reduce sales volume and increase compliance costs, hampering profitability.

Q3: Are there new formulations or innovations that could rescue Exalgo's market share?
A: Development of abuse-deterrent formulations, combination therapies, or alternative delivery systems could offer niche growth; however, regulatory and R&D costs are significant barriers.

Q4: How does Exalgo compare competitively to other extended-release opioids?
A: Exalgo occupies a smaller market segment (~10%), with OxyContin and Fentanyl patches having larger shares. Its unique benefit lies in specific patient applications, but overall market share is diminishing.

Q5: What strategic options remain for Exalgo's manufacturer?
A: Options include repositioning in niche markets, innovating with abuse-deterrent or alternative formulations, or divesting and focusing on non-opioid pain management solutions.

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References

1. Grand View Research (2022). Opioid Market Size, Share & Trends.
2. CDC (2016). CDC Guideline for Prescribing Opioids for Chronic Pain.
3. FDA (2012). Postmarket Strategies for Opioid Medications.
4. Market Watch (2022). Global Extended-Release Opioids Market Analysis.
5. Drug Patent Watch (2023). Patent Expirations and Generics for Hydromorphone.