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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Palopegteriparatide has ninety-eight patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for palopegteriparatide

International Patents:	98
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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	216490-002	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-002	Aug 9, 2024		RX	Yes	No	11,918,628		Y	Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes	11,890,326		Y	Y

International Patents for palopegteriparatide

Country	Patent Number	Title	Estimated Expiration
Finland	3518960
Mexico	2019003182	COMPUESTOS DE HORMONA PARATIROIDEA CON BAJAS RELACIONES PICO - VALLE. (PTH COMPOUNDS WITH LOW PEAK-TO-TROUGH RATIOS.)
Japan	7434419

Palopegteriparatide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Palopegteriparatide

Introduction to Palopegteriparatide

Palopegteriparatide, marketed as YORVIPATH®, is a groundbreaking treatment for hypoparathyroidism, a rare endocrine disorder characterized by the underproduction of parathyroid hormone (PTH). Developed by Ascendis Pharma, this drug has recently gained FDA approval, marking a significant milestone in the treatment of this condition.

FDA Approval and Clinical Trials

The FDA approval of palopegteriparatide was based on positive data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials. These trials demonstrated the efficacy and safety of the drug, with 79% of patients achieving normal serum calcium levels and independence from conventional therapy, compared to 5% in the placebo group[2][3].

Market Growth and Projections

The hypoparathyroidism market, driven by the introduction of innovative therapies like palopegteriparatide, is expected to exhibit impressive growth. According to DelveInsight, the market size for hypoparathyroidism reached USD 250 million in 2022 across the 7MM (the United States, EU-4, the United Kingdom, and Japan) and is projected to grow significantly by 2032 with a notable CAGR[1].

Key Companies and Therapies

Ascendis Pharma, along with other companies such as Amolyt Pharma, Bridgebio, and Calcilytix Therapeutics, is at the forefront of developing innovative treatments for hypoparathyroidism. Palopegteriparatide, along with other therapies like Eneboparatide (AZP-3601) and Encaleret (BBP-305/CLTX-305), is anticipated to capture a substantial market share in the coming years[1].

Treatment Impact and Patient Outcomes

Palopegteriparatide has shown significant improvements in patient outcomes. The drug has been associated with improved kidney function, as evidenced by increased estimated glomerular filtration rate (eGFR) in patients with chronic hypoparathyroidism. Additionally, long-term treatment has normalized bone remodeling, addressing key issues related to bone health in these patients[3][4].

Commercialization and Market Strategy

Ascendis Pharma plans to complete commercial product manufacturing for the US market, with initial supply expected in the first quarter of 2025. The company also intends to offer patient services through its US Ascendis Signature Access Program, which includes support for the treatment journey and financial assistance programs for eligible individuals with hypoparathyroidism[2].

Financial Implications

The approval and commercialization of palopegteriparatide are expected to have a positive impact on Ascendis Pharma's financial trajectory. Positive long-term data from clinical trials could translate to sustained market presence and potential revenue growth. The drug's once-daily dosing and continuous 24-hour PTH exposure are designed to enhance patient compliance and treatment efficacy, which could further boost its market performance[4].

Market Segmentation and Revenue Projections

The hypoparathyroidism treatment market is segmented into different drug classes, with calcium supplements currently holding the largest market share (approximately 38%). However, PTH therapies, including palopegteriparatide, are expected to exhibit substantial growth. Sales through retail pharmacies are projected to generate maximum revenue, followed by hospital pharmacies[1].

Technological Advancements and Competitive Landscape

The extensive radiation treatment for cancer on the neck or face, coupled with new technological advancements, is poised to further enhance the overall development of the hypoparathyroidism treatment market. The parenteral method is anticipated to be the fastest-growing segment compared to oral methods, which bodes well for palopegteriparatide, given its injectable nature[1].

Patient and Community Impact

The FDA approval of palopegteriparatide is a significant milestone for the hypoparathyroidism community. As noted by Patty Keating, executive director of the HypoPARAthyroidism Association, this approval marks an important step in addressing the significant unmet medical needs of patients with this condition[2].

Key Takeaways

• Market Growth: The hypoparathyroidism market is expected to grow significantly by 2032, driven by the introduction of innovative therapies like palopegteriparatide.
• Clinical Efficacy: Palopegteriparatide has demonstrated significant improvements in patient outcomes, including normalized serum calcium levels, improved kidney function, and normalized bone remodeling.
• Commercial Strategy: Ascendis Pharma plans to offer comprehensive patient services and financial assistance programs to support the treatment journey.
• Financial Trajectory: Positive long-term data and market performance are expected to contribute to sustained revenue growth for Ascendis Pharma.

FAQs

Q: What is palopegteriparatide, and how is it used? A: Palopegteriparatide, marketed as YORVIPATH®, is a treatment for hypoparathyroidism. It is administered via a once-daily injection and provides continuous 24-hour PTH exposure to help normalize serum calcium levels and improve patient outcomes.

Q: What were the key findings from the clinical trials for palopegteriparatide? A: The Phase 3 PaTHway trial showed that 79% of patients achieved normal serum calcium levels and independence from conventional therapy. The trial also demonstrated significant improvements in kidney function and bone remodeling[2][3].

Q: Which companies are leading the development of hypoparathyroidism therapies? A: Ascendis Pharma, Amolyt Pharma, Bridgebio, and Calcilytix Therapeutics are among the prominent companies developing innovative therapies for hypoparathyroidism[1].

Q: How is the market for hypoparathyroidism treatments expected to grow? A: The market is expected to exhibit impressive growth by 2032, driven by an increase in the patient pool and the entry of emerging therapies like palopegteriparatide[1].

Q: What support services will Ascendis Pharma offer for patients treated with palopegteriparatide? A: Ascendis Pharma plans to offer patient services through its US Ascendis Signature Access Program, including support for the treatment journey and financial assistance programs for eligible individuals with hypoparathyroidism[2].

Sources:

1. GlobeNewswire: Hypoparathyroidism Market is Expected to Exhibit Impressive Growth by 2032, Assesses DelveInsight | Leading Companies Developing Therapies - Ascendis Pharma, Amolyt Pharma, Bridgebio, Calcilytix Therapeutics.
2. HCPLive: FDA Approves Palopegteriparatide for Hypoparathyroidism.
3. PubMed: 1-Year Results from the Phase 3 PaTHway Trial.
4. Stock Titan: New 3-Year Skeletal Dynamics Data for Adults with Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide) Presented at ASBMR 2024.