LYVISPAH Drug Patent Profile

Which patents cover Lyvispah, and what generic alternatives are available?

Lyvispah is a drug marketed by Amneal and is included in one NDA. There are five patents protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in LYVISPAH 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 Lyvispah

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

Summary for LYVISPAH

International Patents:	10
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	150
Patent Applications:	3,931
Drug Prices:	Drug price information for LYVISPAH
What excipients (inactive ingredients) are in LYVISPAH?	LYVISPAH excipients list
DailyMed Link:	LYVISPAH at DailyMed

See drug prices for LYVISPAH

Pharmacology for LYVISPAH

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

US Patents and Regulatory Information for LYVISPAH

LYVISPAH is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		RX	Yes	No			Y
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		RX	Yes	Yes			Y
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		RX	Yes	No			Y

International Patents for LYVISPAH

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

Country	Patent Number	Title	Estimated Expiration
Japan	2022544901	４－アミノ－３－置換ブタン酸誘導体の安定化製剤
Japan	7444967
Mexico	2022001139	FORMULACIONES ESTABILIZADAS DE DERIVADOS DE ACIDO 4-AMINO-3-SUSTITUIDO BUTANOICO. (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES.)

LYVISPAH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LYVISPAH

Introduction to LYVISPAH

LYVISPAH, a baclofen oral granule specialty product, was approved by the U.S. Food and Drug Administration (FDA) in December 2021. This drug is specifically designed for the treatment of spasticity associated with multiple sclerosis and other spinal cord disorders[4][5].

Market Need and Demand

The launch of LYVISPAH addresses a significant need in the market for more flexible and patient-friendly treatment options for spasticity. Clinicians have emphasized the necessity for new formulations that can benefit patients who have difficulty swallowing pills, a common issue among those suffering from spasticity[5].

Product Innovations

LYVISPAH offers several innovative features that set it apart from traditional muscle relaxants. It is available in single-dose packets of granules in 5mg, 10mg, and 20mg strengths, which can be administered directly into the mouth, mixed with liquids or foods, or through an enteral feeding tube. This flexibility in dosing is a key trend in the muscle relaxant drugs market, where companies are developing customized products to sustain their market position[1].

Market Size and Growth

The global muscle relaxant drugs market, within which LYVISPAH operates, is projected to grow significantly. In 2022, the market size was valued at $3.68 billion and is expected to grow at a compound annual growth rate (CAGR) of 4.4% from 2023 to 2032, reaching $5.67 billion by the end of the forecast period[4].

Regional Market Dominance

North America, particularly the United States, dominates the global muscle relaxant drugs market due to its well-developed healthcare system and an aging population, which increases the demand for muscle relaxants. The Asia Pacific region is expected to be the fastest-growing region, driven by increasing R&D investments, infrastructural development, and a rise in musculoskeletal disorders[4].

Competitive Landscape

LYVISPAH enters a competitive market where major pharmaceutical companies such as Pfizer, Amneal Pharmaceuticals, and Merck & Co. are key players. Amneal Pharmaceuticals, in particular, has strengthened its position in the neurology space with the launch of LYVISPAH and the acquisition of Saol Therapeutics’ baclofen franchise[1][3].

Financial Performance of Amneal Pharmaceuticals

The financial trajectory of LYVISPAH is closely tied to the performance of Amneal Pharmaceuticals. Here are some key financial highlights:

• Revenue: For the six months ended June 30, 2023, Amneal Pharmaceuticals reported net revenue of $1,156,586, up from $1,056,988 in the same period of 2022[2].
• Gross Profit: The gross profit for the six months ended June 30, 2023, was $398,207, an increase from $375,090 in the previous year[2].
• Net Income: Despite operational expenses, Amneal Pharmaceuticals reported a net income of $4,974 for the six months ended June 30, 2023, compared to a net loss of $122,964 in the same period of 2022[2].

Launch and Commercialization

LYVISPAH was launched in June 2022, marking a significant step in Amneal Pharmaceuticals' strategy to expand its Specialty business. The product is available through both specialty and retail channels, supported by a full patient support program, including free home delivery through a partnership with BlinkRx[3].

U.S. Market Sales

The U.S. annual sales for baclofen, the active ingredient in LYVISPAH, were $130 million for the 12 months ended March 2022. This indicates a substantial market potential for LYVISPAH, especially given its innovative formulation and patient-friendly administration options[3].

Challenges and Risks

While LYVISPAH presents a promising opportunity, there are several challenges and risks associated with its commercialization. These include competition from brand and generic drug companies, the need to manage growth through acquisitions, dependence on a limited number of products for substantial revenue, and potential supply chain disruptions[3].

Future Outlook

The approval and launch of LYVISPAH have provided a clear path to growth and continued profitability for Amneal Pharmaceuticals. The company's strategy to expand its neurology presence and introduce new branded products over the next several years positions LYVISPAH as a key driver of this growth. As the market continues to evolve with new innovations and increasing demand, LYVISPAH is poised to play a significant role in the muscle relaxant drugs market.

Key Takeaways

• Innovative Product: LYVISPAH offers flexible, customized dosing options for patients with spasticity.
• Market Growth: The global muscle relaxant drugs market is expected to grow at a CAGR of 4.4% from 2023 to 2032.
• Regional Dominance: North America leads the market, with the Asia Pacific region expected to be the fastest-growing.
• Financial Performance: Amneal Pharmaceuticals has seen increased revenue and gross profit, with a positive net income in recent periods.
• Commercialization: LYVISPAH is supported by a full patient support program and is available through multiple channels.

Frequently Asked Questions (FAQs)

Q: What is LYVISPAH used for? A: LYVISPAH is used for the treatment of spasticity associated with multiple sclerosis and other spinal cord disorders.

Q: How is LYVISPAH administered? A: LYVISPAH can be administered directly into the mouth, mixed with liquids or foods, or through an enteral feeding tube.

Q: Who are the key players in the muscle relaxant drugs market? A: Key players include Pfizer, Amneal Pharmaceuticals, and Merck & Co.

Q: What is the projected growth rate of the global muscle relaxant drugs market? A: The market is expected to grow at a CAGR of 4.4% from 2023 to 2032.

Q: How much were the U.S. annual sales for baclofen in 2022? A: The U.S. annual sales for baclofen were $130 million for the 12 months ended March 2022.

Cited Sources

1. GlobeNewswire: Pfizer, Amneal Pharmaceuticals, and Merck & Co. Lead the Global Muscle Relaxant Drugs Market with Innovative Drug Offerings and Strong Market Presence.
2. Fintel.io: Amneal Pharmaceuticals, Inc. - Quarterly Report - August 08, 2023.
3. Amneal Pharmaceuticals: Amneal Launches LYVISPAH® (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders.
4. Polaris Market Research: Muscle Relaxant Drugs Market Trend & Growth Driver 2023-2032.
5. PR Newswire: Saol Therapeutics Announces FDA Approval of LYVISPAH (baclofen) Oral Granules and the Divestiture of Its Plasma-Derived Hyperimmune Portfolio.