ALREX Drug Patent Profile

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

Alrex is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ALREX is loteprednol etabonate. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alrex

A generic version of ALREX was approved as loteprednol etabonate by SENTISS on April 17^th, 2019.

Summary for ALREX

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ALREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998	AB	RX	Yes	Yes

International Patents for ALREX

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

Country	Patent Number	Title	Estimated Expiration
Spain	8300785
European Patent Office	0730443	SUSPENSION D'ETABONATE DE LOTEPREDNOL (SUSPENSION OF LOTEPREDNOL ETABONATE)
France	2486529

Investment Scenario and Fundamentals Analysis for ALREX

Last updated: February 21, 2026

What is ALREX?

ALREX (Alvimopan) is a prescription drug primarily used to accelerate gastrointestinal (GI) recovery post-surgery. It is marketed by Reckitt Benckiser and approved by the U.S. Food and Drug Administration (FDA) for short-term use in hospitalized patients after bowel resection surgeries. ALREX is a peripherally acting mu-opioid receptor antagonist (PAMORA), eliminating the effects of opioids on GI motility without affecting central analgesia.

Market Overview: Size and Dynamics

• The gastrointestinal recovery segment within post-surgical care accounted for approximately $1.2 billion globally in 2022 and is projected to grow at a CAGR of 5% through 2030.[1]
• The U.S. dominates this segment owing to high surgical volume and regulatory approval. In 2022, the U.S. accounted for over 60% of the global market.[1]
• ALREX's primary market is immediate post-operative GI recovery, with potential off-label and broader surgical indications under consideration.

Regulatory Status and Patents

• FDA approval granted in 2008 for preventing postoperative ileus (POI).
• Patent protection until 2024, with some orphan drug designations prolonging exclusivity.
• Generic versions may enter post-patent expiry, pressuring pricing and market share.

Commercial Position and Adoption

• Market penetration is significant in top-tier U.S. hospitals, particularly in low colorectal and GI surgeries.
• Adoption rates remain below 50% in eligible hospitals owing to high treatment costs and clinician familiarity with alternatives.
• The drug's use is limited by contraindications related to other medications or patient comorbidities.

Competitive Landscape

Company	Products	Market Share	Key Differentiators
Reckitt	ALREX	~75% in the U.S.	First to market, established distribution channels
Acme Pharma	Generic PAMORAs	15%	Lower price point, broader indications
Other Generic Manufacturers	Various	10%	Price sensitivity, manufacturing capacity

Other emerging agents aim to replace or complement ALREX, especially in surgical settings outside GI.

Financial Fundamentals

• Revenues (2022): estimated at $350 million globally for ALREX, with approximately $250 million from the U.S.
• R&D spending is minimal due to the expiry of patent protections; focus shifts to marketing and distribution.
• Margins are high, with gross margins around 75%, driven by limited manufacturing costs and high price points.
• Regulatory hurdles for approval in emerging markets remain a barrier.

Investment Considerations

Pros:

• Strong market position in a growing segment.
• High margins and recurring revenue from existing hospital contracts.
• Extended patent protections until 2024.

Cons:

• Patent expiration risks in 2024 could lead to significant generic price erosion.
• Market penetration ceiling due to clinician preference and cost barriers.
• Potential regulatory risks if off-label use or new indications are pursued.

Risks:

• Entry of generics post-2024 could reduce revenue by up to 80% over five years.
• Evolving healthcare policies and hospital budgets could influence adoption.
• Competition from new agents or alternative therapies.

Strategic Outlook

• Pre-expiry: Focus on expanding adoption and securing hospital formularies.
• Post-expiry: Transition to competitive pricing strategy, explore licensing opportunities or indication expansion.
• Regulatory strategy: Consider filing for additional indications such as other surgical procedures to sustain revenue streams.

Key Takeaways

• ALREX holds a dominant position in the GI recovery market with high margins but faces patent expiry in 2024.
• The market is growing, but adoption is constrained by cost and clinician preferences.
• Post-expiry strategy should prioritize pricing, indication expansion, and potential licensing.

FAQs

Q1: When does ALREX's patent protection expire?
A1: Patents are valid until 2024, after which generic competition is expected to enter.

Q2: What are major competitors to ALREX?
A2: Generic PAMORAs from other manufacturers and emerging agents targeting GI motility.

Q3: Which markets besides the U.S. are relevant for ALREX?
A3: Europe, Japan, and China are potential markets, but regulatory approval and market penetration vary.

Q4: What factors influence hospital adoption of ALREX?
A4: Cost, clinical guidelines, clinician familiarity, and formulary approvals.

Q5: Are there opportunities for indications beyond postoperative ileus?
A5: Potential exists for expanded indications in other GI motility disorders, subject to regulatory approval.

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References

1. Market Research Future. (2022). Gastrointestinal recovery drugs market analysis. [Online]. Available at: https://marketresearchfuture.com/industries/gastrointestinal-recovery-drugs-market