LOREEV XR Drug Patent Profile

Which patents cover Loreev Xr, and what generic alternatives are available?

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-five patent family members in thirty countries.

The generic ingredient in LOREEV XR is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven 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:	35
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	4,528
Drug Prices:	Drug price information for LOREEV XR
What excipients (inactive ingredients) are in LOREEV XR?	LOREEV XR excipients list
DailyMed Link:	LOREEV XR at DailyMed

See drug prices for LOREEV XR

Pharmacology for LOREEV XR

Drug Class

Benzodiazepine

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			Y
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-003	Aug 27, 2021		RX	Yes	Yes			Y
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-004	Feb 16, 2022		RX	Yes	No			Y
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-002	Aug 27, 2021		RX	Yes	No			Y

International Patents for LOREEV XR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2856181
Brazil	112015016304	formulações de lorazepam de liberação sustentada
Japan	2017019880	ロラゼパムの徐放性製剤 (SUSTAINED RELEASE FORMULATIONS OF LORAZEPAM)
European Patent Office	2943185	FORMULATIONS À LIBÉRATION PROLONGÉE DE LORAZÉPAM (SUSTAINED RELEASE FORMULATIONS OF LORAZEPAM)

LOREEV XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LOREEV XR

Introduction to LOREEV XR

LOREEV XR is an extended-release formulation of lorazepam, a benzodiazepine used for the treatment of anxiety disorders, preoperative sedation, anterograde amnesia, and status epilepticus in adults. Approved by the U.S. FDA in August 2021, LOREEV XR offers a convenient once-daily dosing regimen, simplifying the treatment process for patients who previously had to take lorazepam tablets multiple times a day[4][5].

Market Size and Growth

The global benzodiazepine drugs market, within which LOREEV XR operates, is projected to experience significant growth. As of 2022, the global benzodiazepine drugs market was valued at approximately $2.35 billion and is expected to reach $3.1 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 2.8%[1].

Regional Market Dynamics

North America is anticipated to be the most favorable regional market for benzodiazepine drug manufacturers, including LOREEV XR. This region held a market share of about 37.2% in 2021 and is expected to continue its dominance due to the high prevalence of mental health disorders and the robust healthcare infrastructure[1].

Product Segment Growth

LOREEV XR falls under the lorazepam segment, which is part of the broader benzodiazepine market. The alprazolam segment, another key player in this market, is expected to grow at a CAGR of 3%, indicating a strong demand for benzodiazepines. The approval of new products like LOREEV XR is likely to contribute to this growth, as it offers an improved dosing regimen and extended-release formulation[1].

Regulatory Approvals and Impact

The approval of LOREEV XR by the U.S. FDA in August 2021 is a significant milestone. Such regulatory approvals are crucial for market growth, as they validate the safety and efficacy of the drug. The FDA approval of LOREEV XR for various indications, including anxiety disorders and status epilepticus, is expected to boost its adoption and sales[4].

Promotional and Marketing Strategies

Companies like Alvogen, the distributor of LOREEV XR, are investing heavily in promotional activities to drive the use of their products. For instance, in 2021, over 4,820 paid interactions across 3,960 physicians were recorded for LOREEV XR, highlighting the extensive promotional efforts aimed at increasing physician awareness and prescribing rates[2].

Pricing and Patient Savings Programs

To make LOREEV XR more accessible, the LOREEV Patient Savings Program offers eligible insured patients the option to pay as little as $20 per month. This pricing strategy is designed to increase patient adherence and attract more users, thereby driving sales and market growth[5].

Competitive Landscape

The benzodiazepine drugs market is competitive, with several key players such as Pfizer Inc., Akorn Inc, Hikma, Hameln Pharmaceutical, and others. The market share of the top 5 companies in this sector is approximately 24.6%. LOREEV XR, with its unique extended-release formulation, positions itself as a competitive option within this market[1].

Clinical and Therapeutic Benefits

LOREEV XR offers several clinical benefits, including once-daily dosing and continuous medication delivery over 24 hours. This extended-release formulation helps in maintaining a stable level of medication in the body, reducing the highs and lows associated with immediate-release lorazepam. This convenience and therapeutic efficacy are expected to drive patient and physician preference for LOREEV XR[5].

Side Effects and Safety Considerations

While LOREEV XR provides several benefits, it also comes with potential side effects such as sedation, dizziness, weakness, and unsteadiness. Additionally, it is a federally controlled substance (CIV) due to the risk of abuse, misuse, and addiction. Patients and healthcare providers must be aware of these risks and monitor usage carefully[5].

Financial Projections

The financial trajectory for LOREEV XR is closely tied to the overall growth of the benzodiazepine drugs market. With increasing product approvals, growing prevalence of anxiety disorders, and the convenience of once-daily dosing, LOREEV XR is poised to capture a significant share of the market. The global benzodiazepine drugs market's projected growth to $3.1 billion by 2032 indicates a favorable financial outlook for LOREEV XR and similar products[1][4].

Long-Term Growth Drivers

Several factors will drive the long-term growth of LOREEV XR:

• Rising Urbanization and Work Pressure: Increasing urbanization and work-related stress are expected to escalate mental health issues, thereby increasing the demand for benzodiazepines like LOREEV XR.
• Product Development: Continuous investments in clinical studies and the development of novel medicines with minimal side effects will enhance the acceptance and sales of LOREEV XR.
• Regulatory Support: Ongoing approvals by regulatory bodies will further boost the market growth of LOREEV XR and similar benzodiazepine drugs[1].

Key Takeaways

• Market Growth: The global benzodiazepine drugs market, including LOREEV XR, is expected to grow at a CAGR of 2.8% to reach $3.1 billion by 2032.
• Regional Dominance: North America will remain a key market for LOREEV XR due to its high prevalence of mental health disorders.
• Product Benefits: LOREEV XR's once-daily dosing and extended-release formulation offer significant clinical and therapeutic benefits.
• Regulatory Approvals: FDA approval and ongoing regulatory support are crucial for the market success of LOREEV XR.
• Pricing Strategies: Patient savings programs and competitive pricing will help increase patient adherence and drive sales.

FAQs

What is LOREEV XR used for?

LOREEV XR is used for the treatment of anxiety disorders, preoperative sedation, anterograde amnesia, and status epilepticus in adults[4].

How is LOREEV XR different from traditional lorazepam?

LOREEV XR is an extended-release formulation of lorazepam, allowing for once-daily dosing compared to the multiple daily doses required for traditional lorazepam[5].

What are the common side effects of LOREEV XR?

Common side effects include sedation, dizziness, weakness, and unsteadiness. It is also a federally controlled substance due to the risk of abuse and addiction[5].

How does the LOREEV Patient Savings Program work?

Eligible insured patients can pay as little as $20 per month for LOREEV XR through the LOREEV Patient Savings Program[5].

What is the projected market growth for benzodiazepine drugs, including LOREEV XR?

The global benzodiazepine drugs market is expected to grow at a CAGR of 2.8% to reach $3.1 billion by 2032[1].

Sources

1. Fact.MR: Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032.
2. MDDetails: Loreev XR 2021 U.S. PROMOTIONAL AUDIT REPORT.
3. Oklahoma.gov: Drug Utilization Review Board.
4. Coherent Market Insights: Benzodiazepine Drugs Market - Price, Size, Share & Growth.
5. LOREEV XR: LOREEV XR® (lorazepam) extended-release capsules.