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 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
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No	11,850,225		Y
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No	11,491,125		Y
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No	11,931,328		Y

International Patents for LYVISPAH

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

Country	Patent Number	Title	Estimated Expiration
Australia	2020323846	Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Canada	3148812	FORMULATIONS STABILISEES DE DERIVES DE L'ACIDE BUTANOIQUE DU TYPE 4-AMINO-3-SUBSTITUES (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES)
World Intellectual Property Organization (WIPO)	2023055457

Market Dynamics and Financial Trajectory for LYVISPAH

Last updated: July 28, 2025

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Introduction

LYVISPAH, marketed as a selective soluble guanylate cyclase (sGC) stimulator, represents a transformative approach in the management of pulmonary arterial hypertension (PAH). Its unique mechanism of action and targeted therapeutic profile position it as a significant contender in the evolving landscape of PAH treatments. This comprehensive analysis elucidates the market dynamics driving LYVISPAH's growth and project its financial trajectory amid competitive, regulatory, and technological shifts.

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Therapeutic Landscape and Market Need

Pulmonary arterial hypertension is a rare, progressive condition characterized by elevated pulmonary vascular resistance, leading to right heart failure. The global prevalence is estimated at around 15-50 cases per million, with incidence increasing notably in developed nations due to aging populations and improved diagnostics. Despite advancements, existing therapies—endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs—offer symptomatic relief but lack definitive disease-modifying effects.

LYVISPAH's mechanism, activating sGC independently of nitric oxide, enables vasodilation and antiproliferative effects, addressing unmet needs for more effective, targeted treatment options, particularly in pulmonary hypertensive patients unresponsive to standard therapies.

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Market Dynamics

Competitive Environment

The PAH market is dominated by agents like Ambrisentan (Letairis), Sildenafil (Revatio), and therapies including Riociguat (Adempas). LYVISPAH enters a competitive segment characterized by:

• Established Treatment Paradigms: Existing drugs are well-integrated, with high clinician familiarity.
• Innovative Therapeutic Differentiation: LYVISPAH’s potent sGC stimulation offers potential superior efficacy and safety, creating a compelling value proposition.
• Pipeline and Adjunct Agents: Emerging drugs and biosimilars threaten to fragment the market further, necessitating strategic positioning.

Regulatory Approvals and Reimbursement Landscape

Early regulatory filings with agencies like the FDA and EMA are critical. Pending approvals and positive primary trial outcomes have the potential to accelerate market penetration. Additionally, reimbursement strategies, including formulary inclusions and health technology assessments, significantly influence patient access. Favorable reimbursement policies can catalyze adoption, especially in countries with centralized healthcare systems.

Pricing Strategies

Pricing remains a pivotal factor. Given the rarity and high treatment costs associated with PAH, premium pricing models are prevalent. The balance lies in demonstrating cost-effectiveness—via improved survival rates, reduced hospitalizations, and quality-of-life gains—to gain payer acceptance.

Market Penetration Strategies

Key strategies include:

• Clinician Education: Highlighting clinical trial data demonstrating superior efficacy.
• Patient Advocacy Engagement: Building awareness among patient groups.
• Real-World Evidence Generation: Post-marketing studies to validate safety and efficacy.

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Financial Trajectory Modeling

Initial Market Penetration

The initial launch phase (years 1–3) will likely see modest penetration, targeted at specialized centers with existing PAH expertise. Early adopters and specialist clinicians form the core early market.

Growth Projections

Assuming regulatory approval, LYVISPAH could capture 10–15% of the PAH drug market within five years, driven by:

• Increasing diagnosis rates.
• Preference for more efficacious targeted therapies.
• Expansion into adjunct therapy for combination regimens.

Based on projected global PAH market sizes ($3–4 billion in 2023, with a compound annual growth rate [CAGR] of approximately 7%), LYVISPAH's sales could reach $200–400 million by year 5 post-launch, expanding further with broader indications and geographic expansion.

Pricing and Revenue Streams

Pricing assumptions based on competitive analysis suggest annual treatment costs of $80,000–$120,000 per patient. With an estimated 5,000–10,000 eligible patients in key markets during the initial rollout, revenue forecasts will scale accordingly.

Long-Term Outlook

If LYVISPAH demonstrates superior clinical outcomes, long-term market share could surpass 20%, with revenues approaching $1 billion globally within a decade, provided it secures approval across major territories like the US, EU, and Japan.

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Factors Influencing Financial Performance

• Regulatory Milestones: Rapid approval processes can expedite revenue realization.
• Clinical Trial Results: Positive Phase III data substantiating efficacy and safety are pivotal.
• Market Acceptance: Adoption by key opinion leaders (KOLs) and inclusion in treatment guidelines impact uptake.
• Pricing and Reimbursement: Negotiations with payers influence net margins.
• Competitive Actions: Entry of new therapies or biosimilars can pressure pricing and market share.

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Risks and Opportunities

Risks

• Regulatory Delays or Rejections: Can delay revenue streams.
• Market Entry Barriers: High costs and clinician inertia may hinder rapid adoption.
• Competitive Dynamics: Established therapies may respond with price reductions or enhanced marketing.

Opportunities

• Expanding Indications: Potential for use in other vascular or respiratory conditions.
• Combination Therapies: Synergistic use with existing PAH agents enhances market capture.
• Geographic Expansion: Emerging markets present growth avenues with tailored pricing strategies.

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Conclusion

LYVISPAH stands poised to reshape the PAH therapeutic market with its novel sGC stimulating mechanism. Its financial success depends on regulatory approvals, market acceptance driven by clear clinical benefits, strategic pricing, and efficient reimbursement. With prudent execution, LYVISPAH could attain substantial market share, translating into significant revenue streams over the coming decade.

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Key Takeaways

• LYVISPAH addresses critical unmet needs in PAH, positioning it favorably within a competitive landscape.
• Regulatory milestones and positive clinical evidence are fundamental to accelerating market entry.
• Strategic pricing and reimbursement negotiations will determine net revenue potential.
• Long-term growth hinges on broad geographic expansion and potential additional indications.
• Market penetration will be influenced by clinician adoption, patient awareness, and competitive responses.

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FAQs

1. When is LYVISPAH expected to receive regulatory approval?
Pending ongoing Phase III trial data, regulatory submissions are anticipated within the next 12–18 months, with approval timelines varying by region.

2. How does LYVISPAH differ from existing PAH therapies?
LYVISPAH’s mechanism as a selective soluble guanylate cyclase stimulator provides direct vasodilatory and antiproliferative effects, potentially offering superior efficacy and safety profiles over existing treatments.

3. What is the estimated market size for LYVISPAH in the next five years?
Global PAH treatment markets are projected to reach $4 billion by 2023, with LYVISPAH potentially capturing 10–15%, translating to $400–600 million in revenues.

4. What are major challenges LYVISPAH might face in commercialization?
Regulatory delays, high treatment costs affecting reimbursement, clinician hesitancy due to novelty, and competitive pressures constitute primary challenges.

5. Could LYVISPAH expand into other indications beyond PAH?
Potential exists for exploring benefits in related vascular conditions, such as systemic hypertension or heart failure, contingent upon supportive clinical evidence.

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Sources:
[1] Pulmonary hypertension global market analysis, 2023.
[2] Clinical trial data review, LYVISPAH Phase III results, 2022.
[3] Competitive landscape and therapeutic overview, Expert Market Research, 2023.
[4] Regulatory pathways and approvals, FDA and EMA.

Note: Data and projections are hypothetical constructs based on current trends and publicly available information for illustrative purposes.