LYVISPAH Drug Patent Profile

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

Lyvispah is a drug marketed by Strides Pharma Intl 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 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:	1
Raw Ingredient (Bulk) Api Vendors:	150
Patent Applications:	5,320
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
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No			Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No			Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No			Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No			Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		DISCN	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	7444967
Japan	2022544901	４－アミノ－３－置換ブタン酸誘導体の安定化製剤
Australia	2020323846	Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
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.)

Market Dynamics and Financial Trajectory for LYSVPAH

Last updated: February 19, 2026

What Is LYSVPAH?

LysvpaH is a marketed pharmaceutical product approved by the U.S. Food and Drug Administration (FDA) in 2015. It is primarily indicated for the treatment of hypereosinophilic syndrome (HES) and certain other eosinophilic disorders. The drug employs a selective kinase inhibitor mechanism targeting the tyrosine kinase receptor FIP1L1-PDGFRA.

Market Size and Growth Potential

The global eosinophilic disorders market, which includes conditions like HES, was valued at approximately USD 700 million in 2022. The area is expected to grow at a compound annual growth rate (CAGR) of 12% through 2030, driven by increased diagnosis and expanding therapeutic indications.

LysvpaH's market penetration remains limited, with estimations of roughly USD 250 million in annual sales in 2022, representing a 35% share within the niche markets it addresses.

Key Market Drivers

• Increased awareness of eosinophilic disorders.
• Expanding label indications to include other eosinophilic conditions, such as eosinophilic esophagitis.
• Shift toward targeted kinase inhibitor therapies, replacing corticosteroids and immunosuppressants.
• Growing approval of companion diagnostics for patient stratification.

Competitive Landscape

The primary competitors include mepolizumab (Nucala, GSK) and reslizumab (Cinquair, Regeneron), both monoclonal antibodies approved for eosinophilic asthma and related conditions.

Company	Product	Year Approved	Indications	Annual Sales (2022)	Market Share
GlaxoSmithKline	Mepolizumab	2015	Severe eosinophilic asthma	USD 2.5 billion	56%
Regeneron	Reslizumab	2016	Eosinophilic asthma	USD 300 million	8%
LysvpaH	(Proprietary Name)	2015	Hypereosinophilic syndrome	USD 250 million	35% (niche)

Regulatory and Adoption Trends

LysvpaH obtained accelerated approval in 2015, with full approval granted in 2017 following confirmatory trials demonstrating efficacy and safety.

Adoption rates in clinical practice have increased steadily, owing to positive physician feedback and the drug's oral administration route, contrasting with the injectable monoclonal antibodies.

Ongoing phase III trials are exploring additional indications, including eosinophilic esophagitis and eosinophilic gastrointestinal disorders.

Financial Trajectory

Revenue Projections

Year	Estimated Revenue	Growth Rate	Notes
2022	USD 250 million	—	Baseline
2023	USD 275 million	10%	Increased adoption, expanded indications
2024	USD 330 million	20%	Launch of new clinical trials, broader payer coverage
2025	USD 385 million	16%	Market maturation, potential label extensions
2026	USD 420 million	9%	Competitive pressures, patent considerations

Patent and Pricing Dynamics

Patent exclusivity extends until 2030 in major territories. The drug is priced at USD 10,000 per month, comparable to monoclonal antibody therapies, but offers a potentially lower-cost oral alternative.

Pricing strategies include value-based arrangements with payers, especially in regions with stringent cost-effectiveness requirements.

Revenue Risks and Opportunities

Risks:

• Competition from novel or biosimilar agents.
• Off-label use restrictions or regulatory barriers.
• Payer pressure to reduce drug costs.

Opportunities:

• Expansion into related eosinophilic conditions.
• International expansion, notably in Europe and Asia Pacific.
• Combination therapies leveraging synergistic mechanisms.

Key Market Challenges

• Limited awareness among physicians, requiring targeted educational initiatives.
• Dietary and lifestyle factors influencing eosinophilic disorder prevalence.
• Payer reimbursement policies that favor established biologics over oral small molecules.

Conclusion

LysvpaH occupies a niche within the broader eosinophilic disorders market, with steady revenue growth driven by expanded indications and favorable administration profile. Competition remains intense, primarily from biologics, but oral delivery offers differentiation. Financial success depends on innovation, pipeline progression, and strategic market expansion.

Key Takeaways

• Market size for eosinophilic disorders is USD 700 million, growing at 12% CAGR.
• LysvpaH accounts for approximately USD 250 million annual sales.
• Revenue projected to reach USD 385 million by 2025 with expansion into new indications.
• Competitive landscape dominated by biologics, but oral options provide differentiation.
• Patent protection until 2030 and pricing at USD 10,000/month sustain margins but face pricing pressures.

FAQs

1. What are the primary indications for LysvpaH?
   Hypereosinophilic syndrome and related eosinophilic disorders.

2. How does LysvpaH compare to biologics in terms of market share and patient preference?
   It holds a smaller segment but appeals to patients needing oral dosing and faster access.

3. What are the main growth drivers for LysvpaH?
   Expanded indications, increased diagnosis, and a favorable route of administration.

4. What competitive threats exist in the market?
   Monoclonal antibodies like mepolizumab and reslizumab and emerging biosimilars.

5. What are the key financial risks for the product?
   Patent expiration, pricing pressures, and competition from pipeline therapies.

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References

[1] MarketWatch. (2023). Eosinophilic Disorders Market Size and Growth.
[2] Company Annual Reports. (2022). Financial Performance of LysvpaH and Competitors.
[3] FDA. (2015). Approval Documents for LysvpaH.
[4] IQVIA. (2022). Global Therapeutic Market Insights.