FLEQSUVY Drug Patent Profile

When do Fleqsuvy patents expire, and what generic alternatives are available?

Fleqsuvy is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in FLEQSUVY is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fleqsuvy

A generic version of FLEQSUVY was approved as baclofen by IVAX SUB TEVA PHARMS on July 21^st, 1988.

Summary for FLEQSUVY

International Patents:	4
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	150
Patent Applications:	3,904
Drug Prices:	Drug price information for FLEQSUVY
What excipients (inactive ingredients) are in FLEQSUVY?	FLEQSUVY excipients list
DailyMed Link:	FLEQSUVY at DailyMed

See drug prices for FLEQSUVY

Pharmacology for FLEQSUVY

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

Paragraph IV (Patent) Challenges for FLEQSUVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLEQSUVY	Oral Suspension	baclofen	25 mg/5 mL	215602	1	2022-05-20

US Patents and Regulatory Information for FLEQSUVY

FLEQSUVY is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes
Azurity	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes			Y

International Patents for FLEQSUVY

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3509592	SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
Canada	3036356	SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
World Intellectual Property Organization (WIPO)	2018049184

FLEQSUVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLEQSUVY (Baclofen Oral Suspension)

Market Overview of Muscle Relaxant Drugs

The global muscle relaxant drugs market, within which FLEQSUVY operates, is experiencing significant growth. In 2022, the market was valued at USD 3.74 billion and is projected to grow at a CAGR of 4.38% from 2023 to 2030, reaching USD 5.28 billion by 2030[1][4].

Segmentation and Dominance

Route of Administration

The oral segment, which includes FLEQSUVY, dominated the muscle relaxant drugs market with a share of 51.21% in 2022. Oral administration is preferred due to its non-invasiveness, ease of use, and higher patient compliance rates[1][4].

Distribution Channels

Hospital pharmacies captured the highest revenue share of 46.76% in 2022, driven by growing awareness, increasing clinical and hospital visits, and a growing geriatric population. Retail pharmacies are the second largest distribution channel, while online pharmacies are gaining prominence due to their convenience and flexibility[1].

Regional Market

North America

North America, particularly the United States, dominates the muscle relaxant drugs market, accounting for 37.56% of the market share in 2022. This dominance is attributed to high-quality infrastructure, rising investments by the government, and an increasing incidence of chronic diseases[1][4].

Asia Pacific

The Asia Pacific region is expected to witness the fastest growth due to rising demand for therapeutics, increasing R&D investments by governments, and rapid infrastructural development. Strategic activities by key market players to expand their presence in this region also contribute to its growth[1][4].

FLEQSUVY (Baclofen Oral Suspension) Specifics

Indications and Usage

FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms, concomitant pain, clonus, and muscular rigidity. It may also be valuable in patients with spinal cord injuries and other spinal cord diseases[5].

Pharmacokinetics and Safety

FLEQSUVY has a well-documented safety profile. Peak plasma concentrations are achieved in about 1 hour, and the apparent elimination half-life is approximately 5.6 hours. Common adverse reactions include transient drowsiness, dizziness, and weakness[5].

Market Entry and Competition

Generic Alternatives

ANI Pharmaceuticals has launched a generic version of baclofen oral suspension, which competes directly with FLEQSUVY. This generic alternative is part of ANI's strategy to expand its presence in both generic and branded pharmaceutical sectors[2].

Strategic Activities

Azurity Pharmaceuticals received FDA clearance for FLEQSUVY in February 2022, which has helped drive the market growth for oral muscle relaxant formulations. Such strategic activities by key players are crucial for market expansion[1].

Financial Trajectory

Revenue Potential

The U.S. annual sales for baclofen oral suspension, including FLEQSUVY and its generic alternatives, are estimated to be approximately $39 million, according to IQVIA[2].

Company Performance

ANI Pharmaceuticals, which launched a generic version of baclofen oral suspension, has shown robust financial growth. The company's revenue increased by 53.87% over the last twelve months as of Q4 2023, indicating strong market demand for its products. ANI is trading at a relatively low P/E ratio compared to its near-term earnings growth, making it an attractive investment prospect[2].

Key Trends and Drivers

Patient-Centric Care

The muscle relaxant drugs market, including FLEQSUVY, is driven by a growing focus on patient-centric care, expansion of distribution channels, and efforts to improve quality of life. The development of targeted drug delivery systems and the discovery of biomarkers are also key drivers[3].

Technological Advancements

The integration of artificial intelligence, machine learning, telehealth, and remote monitoring technologies is expected to shape the market. Advances in neurostimulation techniques and the application of regenerative medicine approaches are also anticipated to contribute to market growth[3].

Key Takeaways

• Market Growth: The global muscle relaxant drugs market is expected to grow at a CAGR of 4.38% from 2023 to 2030.
• Oral Segment Dominance: The oral segment, which includes FLEQSUVY, dominates the market due to its non-invasiveness and patient compliance.
• Regional Dominance: North America leads the market, with the Asia Pacific region expected to grow the fastest.
• Financial Performance: FLEQSUVY and its generic alternatives show promising revenue potential, with companies like ANI Pharmaceuticals exhibiting strong financial growth.
• Key Trends: Patient-centric care, technological advancements, and strategic activities by key players drive the market.

FAQs

1. What is FLEQSUVY used for? FLEQSUVY is used for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms, concomitant pain, clonus, and muscular rigidity[5].

2. What is the expected growth rate of the muscle relaxant drugs market? The global muscle relaxant drugs market is expected to grow at a CAGR of 4.38% from 2023 to 2030[1].

3. Which region dominates the muscle relaxant drugs market? North America dominates the muscle relaxant drugs market, accounting for 37.56% of the market share in 2022[1].

4. What are the common adverse reactions associated with FLEQSUVY? Common adverse reactions include transient drowsiness, dizziness, and weakness[5].

5. Who are the key competitors in the market for baclofen oral suspension? Key competitors include Azurity Pharmaceuticals (FLEQSUVY) and ANI Pharmaceuticals (generic baclofen oral suspension)[1][2].

Cited Sources

1. Grand View Research - Muscle Relaxant Drugs Market Size & Share Report, 2030
2. Investing.com - ANI Pharmaceuticals launches generic Baclofen Oral Suspension
3. Research and Markets - Muscle Spasticity Market Report 2024
4. Polaris Market Research - Muscle Relaxant Drugs Market Trend & Growth Driver 2023-2032
5. FLEQSUVY - Efficacy and Safety | For Healthcare Providers