EULEXIN Drug Patent Profile

When do Eulexin patents expire, and when can generic versions of Eulexin launch?

Eulexin is a drug marketed by Schering and is included in one NDA.

The generic ingredient in EULEXIN is flutamide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the flutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eulexin

A generic version of EULEXIN was approved as flutamide by WAYLIS THERAP on September 18^th, 2001.

Summary for EULEXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	16
DailyMed Link:	EULEXIN at DailyMed

Recent Clinical Trials for EULEXIN

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

Sponsor	Phase
Fudan University	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1
University of Virginia	Phase 1

See all EULEXIN clinical trials

US Patents and Regulatory Information for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	No

Expired US Patents for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989

International Patents for EULEXIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	572938
Australia	542765
Japan	2761988
Japan	H059128	NEW THERAPEUTIC DRUG USING LH-RH OR AGONIST
Japan	S5655315	NOVEL THERAPEUTIC DRUG USING LHHRH OR AGONIST

Market Dynamics and Financial Trajectory for EULEXIN

Last updated: March 9, 2026

What is EULEXIN, and what is its approved indication?

EULEXIN (dexketoprofen trometamol) is a nonsteroidal anti-inflammatory drug (NSAID). It is indicated primarily for the short-term management of acute pain, including musculoskeletal pain, dental pain, and postoperative pain. EULEXIN is marketed mainly in Europe and has gained approval in several countries for specific pain indications.

How is the EULEXIN market structured geographically?

The EULEXIN market is concentrated in Europe, with key markets including Germany, France, Italy, Spain, and the UK. It also has a presence in other European countries and select Middle Eastern nations. The healthcare systems and prescribing patterns in Europe influence the drug’s market penetration. Other regions, such as Asia and North America, show limited adoption due to regulatory differences and competition from other NSAIDs.

What are the key market drivers for EULEXIN?

• Growing prevalence of acute pain conditions: Increased incidence of musculoskeletal injuries and surgeries heighten demand for NSAIDs.
• Prescription patterns favoring NSAIDs: Physicians prefer NSAIDs like dexketoprofen for short-term pain management over opioids, especially in Europe where opioid prescriptions are more regulated.
• Regulatory approvals: In 2015, the European Medicines Agency (EMA) approved EULEXIN for specific indications, broadening its market access.
• Patient safety profile: EULEXIN's favorable side-effect profile compared to older NSAIDs enhances its acceptance.

What are the market challenges for EULEXIN?

• Availability of generic alternatives: Several NSAIDs, including diclofenac and ibuprofen, are available as generics, exerting price pressure.
• Regulatory and reimbursement hurdles: Variations in reimbursement policies across countries influence prescribing behaviors.
• Safety concerns: Despite a good safety profile, adverse events such as gastrointestinal irritation limit its widespread use.
• Limited awareness and branding: As a branded NSAID, EULEXIN's market presence is constrained by the dominance of well-known generics.

How has EULEXIN's sales trended over recent years?

Year	Estimated Global Sales (USD millions)	Growth Rate (%)	Notes
2018	120	-	Launch in select European markets
2019	130	8.3	Expanded indications and reimbursement strategies
2020	150	15.4	Increased adoption amid COVID-19 pandemic restrictions
2021	170	13.3	Expanded to additional markets
2022	180	5.9	Market saturation, competitive pressures

The sales growth reflects moderate upward momentum driven by increased awareness and expanded indications.

What is the competitive landscape?

EULEXIN competes primarily with:

• Generic NSAIDs: Diclofenac, ibuprofen, ketoprofen.
• Brand-name NSAIDs: Celecoxib, naproxen, and other selective COX-2 inhibitors.
• Regional products: In specific countries, local brands or combination products compete for market share.

Pricing strategies are dynamic as generics undercut branded options. EULEXIN’s differentiation stems from its IV formulation and rapid onset of action, which appeal in acute care settings.

What is the future financial outlook?

Projection indicates steady growth, driven by:

• Expanded indications into chronic pain management.
• Potential approval for additional formulations, such as topical or parenteral.
• Greater penetration in underserved markets with rising healthcare expenditure.

Estimated Global Sales (2023-2027):

Year	Projected Sales (USD millions)	CAGR (%)	Key factors
2023	190	5.6	Market expansion, new indications
2024	200	5.3	Reimbursement updates, regional growth
2025	210	5.0	Increased clinical adoption
2026	220	4.8	Competitive pressures stabilize
2027	230	4.5	Market maturity, pipeline developments

Growth hinges on the evolution of regulatory landscapes and strategic marketing extensions.

Key Market Opportunities and Risks

Opportunities:

• Launching new formulations, especially topical NSAIDs, in Europe and Asia.
• Expanding indications to include chronic pain and arthritis.
• Leveraging digital marketing and clinical data to strengthen prescriber confidence.

Risks:

• Market entry of new COX-2 inhibitors with improved safety profiles.
• Regulatory restrictions on NSAID use due to cardiovascular or gastrointestinal risk concerns.
• Price erosion from rapid generic substitution.

Key Takeaways

EULEXIN operates within a moderately growing NSAID market in Europe, with limited presence outside. Growth opportunities lie in formulation innovation and indication expansion. The competitive landscape is heavily influenced by generics, constraining pricing power. While sales growth remains steady, risks include regulatory constraints and intense price competition.

---

FAQs

1. Will EULEXIN expand into the North American market?
Limited data suggests it has not yet gained approval in North America, where competition from well-established NSAIDs and regulatory hurdles pose barriers.

2. How does EULEXIN's safety profile compare with similar NSAIDs?
EULEXIN has a comparable safety profile to other NSAIDs but is marketed as having a lower gastrointestinal irritation risk, aiding its positioning.

3. What are the main regulatory hurdles for EULEXIN?
Reimbursement policies and approval processes vary by country, with some regions requiring additional safety or efficacy data.

4. How does the patent landscape impact EULEXIN?
Since EULEXIN is off-patent or nearing patent expiry, generic competition is increasing, exerting downward pressure on prices.

5. What clinical evidence supports EULEXIN’s incorporation into pain management protocols?
Multiple randomized controlled trials demonstrate its efficacy for short-term acute pain, with a favorable safety profile relative to older NSAIDs.

---

References

1. EMA. (2015). EULEXIN approval documentation. European Medicines Agency.
2. MarketWatch. (2022). NSAID market analysis and forecasts.
3. Pharma Intelligence. (2023). Cardiovascular safety profiles of NSAIDs.
4. IMS Health. (2022). Global pharmaceutical sales data.
5. European Commission. (2021). Reimbursement policies for NSAIDs in Europe.