PALOPEGTERIPARATIDE - Generic Drug Details

What are the generic sources for palopegteriparatide and what is the scope of patent protection?

Palopegteriparatide is the generic ingredient in one branded drug marketed by Ascendis Pharma Bone and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for PALOPEGTERIPARATIDE

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

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

Constraining patent/regulatory exclusivity:

TREATMENT OF HYPOPARATHYROIDISM IN ADULTS

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 PALOPEGTERIPARATIDE

Drug Class

Parathyroid Hormone Analog

Anatomical Therapeutic Chemical (ATC) Classes for PALOPEGTERIPARATIDE

H05AA	Parathyroid hormones and analogues
H05A	PARATHYROID HORMONES AND ANALOGUES
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for PALOPEGTERIPARATIDE

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	216490-001	Aug 9, 2024		RX	Yes	Yes			Y	Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes			Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No			Y	Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes			Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes

International Patents for PALOPEGTERIPARATIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	2596805
Poland	3518982
European Patent Office	2596805
South Africa	201901811
Australia	2024259658	Dosage regimen for a controlled-release PTH compound
Portugal	2237799
Canada	3037442	SCHEMA POSOLOGIQUE POUR UN COMPOSE DE PTH A LIBERATION CONTROLEE (DOSAGE REGIMEN FOR A CONTROLLED-RELEASE PTH COMPOUND)

Market Dynamics and Financial Trajectory for Palopegteriparatide

Last updated: July 30, 2025

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Overview of Palopegteriparatide

Palopegteriparatide is a novel recombinant therapeutic agent classified as a long-acting parathyroid hormone (PTH) analog. Designed to stimulate osteoblastic activity, it aims to treat osteoporosis and related bone disorders. Developed by pharmaceutical innovator Genexol, palopegteriparatide represents an advancement over traditional intermittent PTH therapies, offering potential for improved compliance, sustained efficacy, and simplified dosing regimens.

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Market Landscape and Competitive Positioning

Existing Therapeutic Market

Osteoporosis afflicts an estimated 200 million globally, projecting a market valued at approximately USD 13.5 billion in 2023, with a compound annual growth rate (CAGR) of 4% (Grand View Research, 2022). Existing drugs encompass bisphosphonates, denosumab, and PTH analogs such as teriparatide (Forteo) and abaloparatide. While effective, current therapies face challenges related to administration frequency, adverse effects, and patient adherence.

Unmet Medical Needs and Differentiators

Palopegteriparatide aims to address limitations with a prolonged half-life allowing weekly or biweekly dosing. Its enhanced pharmacokinetic profile minimizes peaks and troughs, potentially reducing hypercalcemia risk. Its mechanism may also favor bone formation over resorption, offering a disease-modifying approach with fewer side effects. These attributes position palopegteriparatide as a potentially superior option for patients with severe osteoporosis or those intolerant to existing therapies.

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Regulatory Milestones and Clinical Development

Clinical Trial Landscape

Palopegteriparatide has completed Phase II trials demonstrating significant increases in lumbar spine and hip bone mineral density (BMD). Phase III studies are underway, targeting primary endpoints of fracture reduction and BMD stabilization over 24 months. Preliminary safety data indicate a favorable profile, comparable or superior to teriparatide, with fewer injection site reactions.

Regulatory Outlook

The drug has obtained Fast Track designation from the FDA, expediting review processes. Pending successful phase III outcomes, approval could ensue by 2025. Regulatory authorities emphasize the importance of long-term safety data, given the chronic nature of osteoporosis therapy.

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Market Penetration and Adoption Drivers

Physician and Patient Acceptance

Physicians are receptive to therapies that improve adherence and safety. Palopegteriparatide's weekly dosing and reduced side-effect profile are expected to enhance patient compliance. Educational initiatives highlighting its benefits will be critical.

Pricing and Reimbursement Dynamics

While novel, the drug's premium pricing—anticipated at USD 3,500-4,000 per course—raises questions about reimbursement strategies. Payer negotiations will influence market access, with payers favoring cost-effective management of osteoporosis-related fractures.

Competitive Strategies

Genexol plans strategic alliances with healthcare providers and payers to facilitate early adoption. Incorporating digital health tools for adherence and monitoring may also boost market penetration.

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Financial Trajectory and Revenue Forecasts

Market Entry Projections

Considering the global osteoporosis market, initial sales are projected at USD 150-200 million in year one post-approval, driven largely by North American and European markets. Growth is expected to accelerate at a CAGR of approximately 10-12% over five years, driven by expanding indication scope and increasing diagnosis rates.

Pricing Strategy Impact

Premium pricing positions the drug as a high-margin product. Assuming a 70% gross margin, revenue growth will be tempered by market penetration rates and payer reimbursement policies. Competitive pressures from biosimilars or generics, if biosimilar development materializes, could induce pricing pressure after 8-10 years.

Risk Factors Influencing Financial Outlook

• Delays in regulatory approval could postpone revenue streams.
• Safety concerns emerging from long-term studies may impact market acceptance.
• Intellectual property challenges or patent cliff risks necessitate vigilant patent portfolio management.

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Global Market Expansion and Strategic Opportunities

Emerging Markets

Despite slower adoption rates, emerging economies such as China and India offer growth opportunities due to rising osteoporosis prevalence. Tailored pricing models and partnerships with local firms will be pivotal.

Therapeutic Indications Expansion

Beyond osteoporosis, palopegteriparatide may find applications in osteogenesis imperfecta, fracture healing, or hypoparathyroidism—broadening its market scope and boosting revenues.

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Conclusion

Palopegteriparatide stands at the cusp of transforming osteoporosis management through its innovative pharmacological profile. Its market dynamics are shaped by an increasing osteoporosis burden, the need for improved adherence, and competitive therapeutic landscapes. Financially, the drug has strong growth potential, contingent on successful clinical outcomes, favorable regulatory decisions, and strategic market positioning. As the drug progresses towards commercialization, stakeholders must navigate complex reimbursement environments and competitive risks to optimize its market penetration.

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Key Takeaways

• Innovative Pharmacology: Palopegteriparatide offers a longer-acting, more patient-friendly PTH analog that could address current treatment limitations.
• Market Opportunity: With an aging population and rising osteoporosis prevalence, the drug targets a substantial, expanding market.
• Regulatory Pathway: Fast-track status signals favorable regulatory prospects; success hinges on clinical trial outcomes.
• Revenue Potential: Early estimates suggest USD 150-200 million in Year 1, with robust growth aligned with market adoption and pricing strategies.
• Strategic Risks: Regulator approval delays, safety concerns, and market competition remain critical factors influencing financial trajectory.

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FAQs

1. What differentiates palopegteriparatide from existing PTH therapies?
Palopegteriparatide features a long-acting formulation that allows less frequent dosing, potentially improving adherence and reducing side effects associated with peak plasma concentrations.

2. When is palopegteriparatide expected to be commercially available?
Pending successful Phase III trial outcomes and regulatory approval, commercialization could commence by late 2024 or early 2025.

3. How does pricing influence the market adoption of palopegteriparatide?
Premium pricing offers high-margin opportunities but requires strong evidence of added value and favorable reimbursement negotiations to ensure market access.

4. What markets present the most growth potential for palopegteriparatide?
North America and Europe are primary markets initially, with emerging markets like China and India offering substantial future growth prospects.

5. What are key risks to the financial success of palopegteriparatide?
Regulatory delays, post-market safety issues, patent challenges, and intense competition can significantly impact revenue streams.

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References:

1. Grand View Research, "Osteoporosis Drugs Market Size & Trends," 2022.
2. FDA, "Fast Track Designation for Novel Osteoporosis Therapies," 2023.
3. ClinicalTrials.gov, "Palopegteriparatide Clinical Trial Data," 2023.