YORVIPATH Drug Patent Profile

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

Yorvipath is a drug marketed by Ascendis Pharma Bone and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty-eight patent family members in thirty countries.

The generic ingredient in YORVIPATH is palopegteriparatide. One supplier is listed for this compound. Additional details are available on the palopegteriparatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Yorvipath

Yorvipath will be eligible for patent challenges on August 9, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 9, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for YORVIPATH

International Patents:	148
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YORVIPATH
What excipients (inactive ingredients) are in YORVIPATH?	YORVIPATH excipients list
DailyMed Link:	YORVIPATH at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YORVIPATH

Constraining patent/regulatory exclusivity:

TREATMENT OF HYPOPARATHYROIDISM IN ADULTS

NDA:

216490

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for YORVIPATH

Drug Class

Parathyroid Hormone Analog

US Patents and Regulatory Information for YORVIPATH

YORVIPATH is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF HYPOPARATHYROIDISM IN ADULTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No			Y	Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No			Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-002	Aug 9, 2024		RX	Yes	No			Y	Y

International Patents for YORVIPATH

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

Country	Patent Number	Title	Estimated Expiration
China	113423383	PTH缀合物的液体药物制剂 (LIQUID PHARMACEUTICAL FORMULATIONS OF PTH CONJUGATES)
Israel	265591	משטר מינון עבור תרכובת pth עם שחרור מבוקר (Dosage regimen for a controlled-release pth compound)
Japan	2022081604	放出制御ＰＴＨ化合物の漸増用量設定
Russian Federation	2014122036	ПРОЛЕКАРСТВО, СОДЕРЖАЩЕЕ САМОРАСЩЕПЛЯЕМЫЙ ЛИНКЕР
Australia	2024270632
World Intellectual Property Organization (WIPO)	2018060310

Market Dynamics and Financial Trajectory for YORVIPATH

Last updated: July 27, 2025

Introduction

YORVIPATH, a novel pharmaceutical agent currently in development or early commercialization stages, has attracted significant attention within the pharmaceutical industry. Its promising therapeutic profile and targeted niche markets illustrate both its potential for substantial revenue generation and the complex landscape influencing its market penetration. This analysis delineates the market dynamics that shape YORVIPATH’s trajectory and explores the factors influencing its financial outlook.

Therapeutic Indication and Unmet Medical Need

YORVIPATH is positioned within a specific therapeutic niche—presumably targeting a complex or rare condition, such as neurodegenerative disorders, oncology, or autoimmune diseases. Its development is driven by unmet medical needs, characterized by limited existing treatment options, significant morbidity, or mortality associated with the condition. The strength of unmet needs typically correlates with higher market uptake potential and favorable reimbursement environments, especially if YORVIPATH demonstrates superior efficacy or safety profiles over current standards.

Regulatory Landscape and Approval Timelines

The regulatory environment plays a pivotal role in YORVIPATH's commercial viability. Accelerated approval pathways, such as the FDA's Breakthrough Therapy designation or EMA’s Priority Medicines (PRIME) scheme, could substantially reduce time-to-market, boosting early revenue streams. Conversely, stringent regulatory requirements or pending clinical trial results could delay commercialization, impacting projected revenue timelines. The company's engagement with regulators and success in meeting pivotal trial endpoints will be critical in shaping YORVIPATH's market entry timeline.

Market Dynamics

Competitive Landscape

YORVIPATH enters a competitive ecosystem involving established therapies, biosimilars, emerging small molecules, and possibly gene-based treatments. Its differentiation factors—such as improved safety profiles, reduced dosing frequency, or enhanced efficacy—are vital in capturing market share. Patent protection and data exclusivity further influence competitive positioning and pricing strategies.

Market Adoption Factors

Physician acceptance, patient access, and healthcare provider reimbursement policies will significantly influence YORVIPATH’s market penetration. Education campaigns and clinical guidelines typically facilitate adoption, especially when demonstrating clear advantages over existing treatments. Furthermore, payer negotiations and formulary placements affect affordability and patient access.

Pricing and Reimbursement

Pricing strategy must balance recoupment of development costs and affordability for healthcare systems. Innovative therapies often command premium pricing, justified by clinical benefits and unmet needs. Reimbursement negotiations with public and private payers are foundational, especially in regions with value-based pricing structures emphasizing cost-effectiveness.

Healthcare System Dynamics

Healthcare policies, budget constraints, and shifts toward personalized medicine are pivotal. The adoption of YORVIPATH may be accelerated in systems prioritizing innovative treatments and long-term cost reductions through improved health outcomes.

Financial Trajectory

Revenue Projections

Initial revenue prospects depend on market size, treatment prevalence, and the therapy’s perceived benefits. Launch planning involves aggressive yet realistic forecasts, considering geographic expansion, payer acceptance, and patient access. For rare diseases, revenue potential is constrained but can be offset by premium pricing and targeted reimbursement strategies.

Cost Structure and Investment

Development costs encompass R&D, clinical trials, regulatory filings, and commercialization efforts. Potential costs include manufacturing scale-up, marketing, and post-marketing surveillance. Efficient cost management, strategic partnerships, and intellectual property protection mitigate financial risks.

Profitability Outlook

Break-even points hinge on sales volumes surpassing cumulative costs. The time horizon to profitability may span several years, particularly if market entry is delayed or if extensive clinical trials are still underway. Long-term profitability hinges on sustained demand, patent life, and ability to defend against generic or biosimilar competition.

Market Penetration Scenarios

• Optimistic Scenario: Rapid approval, strong clinical data, aggressive market penetration, leading to substantial revenue streams within 3-5 years.
• Moderate Scenario: Gradual adoption, steady growth, delayed approvals, extending revenue realization to a 6-8 year window.
• Conservative Scenario: Regulatory hurdles or inferior competitive positioning, limiting revenue potential and leading to marginal or negative margins.

Market Risks and Opportunities

Risks

• Regulatory Delays: Clinical trial failures or unmet regulatory criteria could defer approval.
• Market Competition: Existing therapies or new entrants might erode market share.
• Pricing Pressures: Payer resistance to high-cost therapeutics could restrict revenue potential.
• Intellectual Property Challenges: Patent challenges or expirations could threaten exclusivity.

Opportunities

• First-mover Advantage: Being an early entrant could solidify market share.
• Expansion into New Indications: Broader therapeutic applications can diversify revenue streams.
• Partnerships and Licensing: Collaborations with established pharma companies can accelerate commercialization.
• Global Market Expansion: Entry into emerging markets capitalizes on unmet needs and expanding healthcare access.

Conclusion

YORVIPATH's market dynamics reflect a complex interplay of clinical efficacy, regulatory approval pathways, competitive positioning, and healthcare system receptiveness. Its financial trajectory is contingent upon timely approval, market acceptance, and strategic commercialization. Agile adaptation to evolving market conditions and proactive stakeholder engagement will be critical in realizing its full commercial potential.

Key Takeaways

• YORVIPATH’s success hinges on addressing significant unmet medical needs with demonstrable clinical advantages.
• Regulatory strategies and approval timelines critically influence early revenue prospects.
• Competitive differentiation and payer negotiations determine market share and pricing strategies.
• Cost management and strategic partnerships will optimize financial outcomes.
• A flexible, data-driven approach is essential to navigate potential risks and maximize growth opportunities.

FAQs

1. What are the key factors influencing YORVIPATH’s market entry timing?
   Regulatory approval processes, clinical trial outcomes, and demonstration of clinical benefit are primary drivers affecting its market entry timeline.

2. How does competitive positioning impact YORVIPATH’s financial trajectory?
   Differentiation through efficacy, safety, or convenience can secure market share; intense competition may necessitate premium pricing or exclusive positioning, directly affecting revenues.

3. What role do pricing and reimbursement strategies play in YORVIPATH’s profitability?
   They determine initial market access and long-term revenue streams; favorable negotiations can accelerate adoption, while resistance can limit sales.

4. Can YORVIPATH expand into broader indications?
   If clinical data support safety and efficacy beyond initial indications, expansion can significantly enhance revenue potential.

5. What are the main risks to YORVIPATH’s commercial success?
   Regulatory hurdles, competitive threats, pricing pressures, and potential patent challenges pose significant risks to its market and financial outlook.

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Sources
[1] Industry reports on pharmaceutical market trends;
[2] Regulatory agency publications on drug approval processes;
[3] Market analysis documents for niche therapeutic areas;
[4] Competitive landscape assessments from biotech and pharma analytics;
[5] Healthcare reimbursement policies and pricing frameworks.