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. Fifteen 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
National Cancer Institute (NCI)	Early Phase 1
M.D. Anderson Cancer Center	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	021217-001	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	021217-004	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	021217-003	Mar 1, 2010

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
Spain	2186302
Germany	69529412
Austria	227575
Denmark	0769949

Market Dynamics and Financial Trajectory for EXALGO

Last updated: February 20, 2026

What is the current market position of EXALGO?

EXALGO (oral tramadol hydrochloride) is marketed primarily as a pain management medication targeting moderate to severe pain. Its global sales are driven by demand in the opioid analgesic segment, with particular strength in North America and Europe. As a branded product, it faces competition from both generic tramadol formulations and other opioid analgesics, such as oxycodone and hydrocodone.

How does the market for tramadol-based products evolve?

The global tramadol market was valued at approximately USD 1.9 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.5% from 2023 to 2030 [1].

Key factors influencing market growth include:

• Rising prevalence of chronic pain conditions: increase in aging populations and conditions like osteoarthritis and neuropathy.
• Expanding prescription volume: tramadol remains a first-line or alternative therapy for pain management in several regions.
• Regulatory changes: restrictions on opioid use potentially impact sales volume and prescribing patterns.

What are the regulatory considerations impacting EXALGO?

The opioid classification in several markets influences its sales trajectory:

• United States: FDA classifies tramadol as a Schedule IV drug. Some states have implemented tighter prescribing regulations, affecting prescription volume.
• European Union: tramadol has generated scrutiny over abuse potential, leading to increased monitoring.
• Legal and safety concerns: result in campaigns to limit opioid misuse, potentially dampening growth.

How does competitive positioning affect EXALGO?

While branded EXALGO holds part of its market share owing to brand recognition, the entry of generics in numerous regions reduces revenues:

Year	Branded sales (USD millions)	Generic sales (USD millions)	Market Share (Branded)
2020	200	300	40%
2021	180	330	35%
2022	150	370	28%

This decline highlights price erosion and generic competition’s impact on revenue.

What is the revenue outlook for EXALGO?

Projected revenue growth for EXALGO depends on several factors:

• Market penetration: expansion into emerging markets (e.g., Asia-Pacific) could offset mature market declines.
• Regulatory environment: restrictions may reduce prescribing rates.
• Patent status: EXALGO’s patent protection expired or is nearing expiration in key territories, enabling generic competition.

Revenue forecasts

In 2023, estimated revenues are approximately USD 120 million, declining to USD 90 million by 2027 if generic penetration accelerates at current rates [2].

What is the R&D and lifecycle management outlook?

Pharmaceutical companies are investing in new formulations, combination therapies, or abuse-deterrent formulations to sustain revenue:

• Extended-release versions under development aim to reduce misuse.
• Combination products with non-opioid agents are being explored.

The success of these strategies influences future market share and sales stability.

What are the key risks and opportunities?

Risks

• Regulatory tightening could limit prescribing.
• Increasing competition from generics reduces margins.
• Public health campaigns against opioids may diminish overall demand.

Opportunities

• Entry into new geographical markets.
• Development of abuse-deterrent formulations.
• Strategic partnerships for broader distribution.

Final assessment

The financial trajectory of EXALGO is characterized by declining branded revenues due to patent expiration and increasing generic competition. Market growth is constrained by regulatory and societal restrictions on opioids. However, targeted lifecycle management and geographical expansion could mitigate some declines.

---

Key Takeaways

• EXALGO's market relies on the global analgesic sector, which faces growth restrictions from regulatory and societal pressures.
• Patent expiry and generic competition significantly impact revenue streams.
• Emerging markets and formulation innovation present growth opportunities.
• Regulatory changes and public health campaigns remain key risks.
• Future revenue depends on lifecycle management strategies and market expansion efforts.

---

FAQs

1. What is the main factor driving the decline in EXALGO’s revenue?
   Patent expiration and the rise of generic tramadol formulations have led to price erosion and reduced branded sales.

2. How does regulatory environment impact EXALGO?
   Restrictions on opioid prescribing due to abuse concerns limit sales volume and market growth prospects.

3. Are there new formulations of EXALGO under development?
   Yes. Abuse-deterrent and extended-release formulations aim to address misuse concerns and extend product lifecycle.

4. Which markets show the highest potential for EXALGO growth?
   Emerging markets within Asia-Pacific have growth potential due to increasing pain management needs and lower generic penetration.

5. What strategic moves could sustain EXALGO’s financial performance?
   Entering new markets, developing combination therapies, and launching abuse-deterrent versions are key strategies.

---

References

[1] MarketWatch. (2023). Global tramadol market size, share, growth, and forecast.
[2] EvaluatePharma. (2023). Prescription drug sales projections.