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 six patents protecting this drug.

This drug has ninety-eight patent family members in twenty-seven 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

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.

Indicators of Generic Entry

Summary for YORVIPATH

International Patents:	98
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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 six 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	216490-001	Aug 9, 2024		RX	Yes	Yes
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

International Patents for YORVIPATH

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

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

YORVIPATH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for YORVIPATH

Introduction to YORVIPATH

YORVIPATH, developed by Ascendis Pharma, is a groundbreaking treatment for adults with chronic hypoparathyroidism. It is a prodrug of parathyroid hormone (PTH 1-34), administered once daily, designed to maintain parathyroid hormone levels within the normal physiological range over a 24-hour period[1].

Regulatory Approvals and Market Authorization

YORVIPATH has received significant regulatory approvals. After an initial rejection by the FDA, it was finally approved in August 2024 for the treatment of adults with chronic hypoparathyroidism. This approval follows earlier marketing authorizations from the European Commission in November 2023 and from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) in April 2024, where it also received orphan drug status[1][4].

Launch and Availability

The commercial rollout of YORVIPATH has begun in several regions. In Germany and Austria, the drug has been available since the first quarter of 2024, with approximately 55 doctors writing prescriptions and around 100 patients receiving the commercial product as of March 31, 2024. The U.S. launch is anticipated in mid-January 2025, with preparations underway, including the Ascendis Signature Access Program accepting prescriptions and enrolling patients starting in December 2024[2][3].

Financial Performance

Revenue and Sales

• In the first quarter of 2024, YORVIPATH generated €1.5 million in revenue, reflecting the initial two months of delivery to patients in Europe[2].
• By the third quarter of 2024, YORVIPATH revenue outside the U.S. had increased to €8.5 million, a 60% sequential quarter-over-quarter increase, driven by growing demand from physicians and patients[3].

Projected Revenue

• Ascendis Pharma expects the U.S. launch to significantly boost revenue. However, the exact pricing for the U.S. market has not been finalized, though it is noted that the list price in Europe is approximately €105,000 (about $114,700) annually[4].

Company Financials

• The overall financial performance of Ascendis Pharma is robust, with total revenue in the third quarter of 2024 reaching €57.8 million. This includes €47.2 million from SKYTROFA, another product by Ascendis, and €8.5 million from YORVIPATH outside the U.S.[3].
• The company’s cash position stands at €626 million as of September 30, 2024, indicating a strong financial foundation to support the launch and marketing of YORVIPATH[3].

Market Dynamics

Competitive Landscape

The approval of YORVIPATH comes at a critical time for hypoparathyroidism patients, especially with Takeda Pharmaceutical set to stop producing its treatment. This creates a significant market opportunity for Ascendis Pharma. However, the company must remain vigilant as new entrants with compelling evidence of their products’ advantages could quickly capture market share[1][4].

Patient Demand and Physician Adoption

There is growing demand for YORVIPATH, with over 600 patients on treatment outside the U.S. as of the third quarter of 2024. This indicates strong physician and patient acceptance, which is crucial for the drug’s long-term market success[3].

Challenges and Opportunities

Manufacturing and Regulatory Hurdles

Ascendis Pharma faced initial manufacturing issues that led to the FDA's rejection of YORVIPATH 15 months prior to its eventual approval. However, these issues have been addressed, and the company is now preparing for a smooth U.S. launch[1].

Expansion and Collaboration

The company is expanding its product portfolio and collaborating with other pharmaceutical giants, such as Novo Nordisk, to explore new therapeutic areas like metabolic and cardiovascular diseases. This strategic move could significantly broaden the commercial potential of the TransCon platform technology used in YORVIPATH[3].

Key Takeaways

• Regulatory Milestones: YORVIPATH has received FDA approval and marketing authorizations in several European countries.
• Financial Performance: Initial revenue is promising, with significant growth expected following the U.S. launch.
• Market Dynamics: The drug faces a competitive landscape but has strong patient and physician demand.
• Challenges and Opportunities: Manufacturing issues have been resolved, and strategic collaborations are set to enhance the drug’s market presence.

FAQs

Q: What is YORVIPATH, and how is it administered? A: YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily to maintain normal physiological parathyroid hormone levels over 24 hours[1].

Q: When is YORVIPATH expected to be available in the U.S.? A: YORVIPATH is anticipated to be available in the U.S. in mid-January 2025, with preparations and patient enrollments starting in December 2024[3].

Q: What were the initial challenges faced by YORVIPATH in gaining FDA approval? A: The FDA initially rejected YORVIPATH due to manufacturing issues related to the company’s production control strategy, which have since been addressed[1].

Q: How much revenue has YORVIPATH generated so far? A: As of the third quarter of 2024, YORVIPATH has generated €8.5 million in revenue outside the U.S.[3].

Q: What is the list price of YORVIPATH in Europe? A: The list price of YORVIPATH in Europe is approximately €105,000 (about $114,700) annually[4].

Cited Sources

1. DelveInsight: YORVIPATH: First Hypoparathyroidism Treatment in Adults
2. Ascendis Pharma: Ascendis Pharma Reports First Quarter 2024 Financial Results
3. StockTitan: Ascendis Pharma Reports Third Quarter 2024 Financial Results
4. MedCity News: Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency
5. Ascendis Pharma: FDA Approves YORVIPATH® (Palopegteriparatide) as the First and Only Treatment for Adults with Chronic Hypoparathyroidism