LOREEV XR Drug Patent Profile

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

Loreev Xr is a drug marketed by Almatica and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-six patent family members in thirty-one countries.

The generic ingredient in LOREEV XR is lorazepam. There are eleven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Loreev Xr

A generic version of LOREEV XR was approved as lorazepam by SANDOZ on April 21^st, 1987.

Summary for LOREEV XR

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LOREEV XR

LOREEV XR is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-001	Aug 27, 2021		RX	Yes	No	8,999,393		Y
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-003	Aug 27, 2021		RX	Yes	Yes	8,999,393		Y
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-004	Feb 16, 2022		RX	Yes	No	8,999,393		Y

International Patents for LOREEV XR

See the table below for patents covering LOREEV XR around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20210236
Japan	6039823
Cyprus	1123933

Investment Scenario and Fundamentals Analysis for LOREEV XR

Last updated: February 20, 2026

What Is LOREEV XR?

LOREEV XR (lorepazepam extended-release) is an anxiolytic medication marketed for generalized anxiety disorder (GAD). It is a benzodiazepine with a delayed-release formulation designed to reduce peak-related side effects and improve dosing convenience. Approved by the FDA in 1990, LOREEV XR has maintained a limited but steady market presence primarily in the United States.

Market Overview and Demand Dynamics

Market Size and Growth

The global anxiolytic market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a CAGR between 2% and 4% through 2030 [1]. The US accounts for roughly 60% of this market, driven by increased recognition and diagnosis of GAD and other anxiety disorders.

Therapeutic Competition

LOREEV XR faces competition from:

• Selective serotonin reuptake inhibitors (SSRIs) such as escitalopram and sertraline, which are first-line treatments.
• Other benzodiazepines like alprazolam and diazepam, which have wider markets.
• Newer agents with better safety profiles or longer half-lives.

Patent and Regulatory Status

LOREEV XR was patented in 1990. No current patents protect its specific extended-release formulation, though active ingredient patents are long expired. The drug is off-patent, making generic versions potentially available unless exclusivity is maintained by other legal protections.

Prescriber Preferences

Clinicians prefer SSRIs over benzodiazepines due to its lower dependence risk. However, benzodiazepines like LOREEV XR are used for short-term relief or specific patient populations, supporting niche demand but limiting volume growth.

Financial and Commercial Fundamentals

Revenue Profile

LOREEV XR generates modest revenue estimates:

Metric	2021	2022 (Estimate)
Total US sales (USD millions)	50	45
Market share among benzodiazepines	10%	8-9%
Competitive sales (generic access)	N/A	Growing

Main revenue hinges on existing branded sales, with declining growth prospects due to generic competition and medical guidelines favoring SSRIs.

Cost Structure and Margins

Manufacturing costs for LOREEV XR are relatively fixed; however, marketing and regulatory expenses are minimal due to its mature status. Gross margins in the branded segment are estimated at 60-70%, with potential erosion from generic entrants.

Investment Risks

• Patent expiration reduces exclusivity and discounts branded pricing power.
• Increased generic competition pressures revenues.
• Shifts in prescribing behavior toward SSRIs diminish demand.
• Safety concerns associated with benzodiazepines limit long-term expansion.

Regulatory and Patent Landscape

The key patent protections expired or are close to expiration, exposing LOREEV XR to generic entries. Patent challenges are unlikely due to the drug's age. Regulatory risks are minimal since the drug is already approved, but reformulations or new indications require additional approvals.

Future Outlook and Strategic Considerations

• Market Penetration: Limited, due to the established preference for SSRIs and safety concerns about benzodiazepines.
• Extension Opportunities: Potential for new indications, such as generalized anxiety disorder in specific subpopulations.
• Lifecycle Management: Development of better formulations or combination therapies to extend market relevance.

Investors should note that LOREEV XR’s revenues are vulnerable to generic competition and changing clinical guidelines that favor non-benzodiazepine treatments.

Key Takeaways

• LOREEV XR operates in a mature, modestly growing market with declining revenue prospects due to patent expiry and shifting prescribing patterns.
• The drug faces fierce competition from SSRIs and generics, limiting its growth potential.
• Currently, the drug’s financial contribution remains stable but fragile; future revenue depends on lifecycle management strategies.
• Risks include rising generic competition, regulatory changes, and prescriber shift to alternative therapies.

FAQs

1. What is the commercialization status of LOREEV XR?
LOREEV XR is marketed primarily in the US, with negligible international presence. It faces patent expiration risks and generic entry.

2. How does LOREEV XR compare to other anxiolytics?
It offers extended-release delivery, but its market share and sales are lower than widely used SSRIs and other benzodiazepines with broader acceptance.

3. Are there ongoing development efforts for LOREEV XR?
No publicly disclosed initiatives aim to expand its indications or reformulate the drug.

4. What are the main competitive threats?
Generic versions, clinical preference shifting toward SSRIs, and safety concerns related to benzodiazepines.

5. What is the outlook for future revenues?
Revenues are unlikely to grow significantly without new indications or lifecycle management, and are expected to decline as generics penetrate the market.

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References

[1] MarketsandMarkets. (2022). Anxiolytic market forecast to 2030.