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 fifty-three 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 September 28, 2037. 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:	153
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

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.

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	Yes
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	Yes			Y	Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	Yes
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-003	Aug 9, 2024		RX	Yes	Yes			Y
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes

International Patents for YORVIPATH

When does loss-of-exclusivity occur for YORVIPATH?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017336249
Australia	2024259658
Brazil	112019005533
Canada	3037442
China	109789189

YORVIPATH (eflornithine) Market Dynamics and Financial Trajectory: Pricing, Coverage, Utilization, and Competitive-Economic Drivers

Last updated: July 19, 2026

Yorvipath’s commercial trajectory is constrained by narrow, high-specificity indication targeting and low addressable population. Financial outcomes track tightly to patient access, payer authorization behavior, and uptake relative to existing hospital/infusion workflows and competing therapies.

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What is Yorvipath (eflornithine) used for, and why do those patients drive revenue dynamics?

Indication scope and addressable population

Yorvipath is an eflornithine product for a life-threatening parasitic disease where rapid reduction of pathogen burden and disease control translate into high medical urgency. Revenue potential is therefore capped by:

• The number of eligible patients within treated geographies
• The speed of identification and referral
• Institutional adoption in hospitals that manage acute cases

Why payer and access shape utilization

In specialty infusion drugs, the dominant determinants of realized sales are not list-price arithmetic but:

• Prior authorization throughput and evidence requirements
• Coverage tiering (preferred vs non-preferred)
• Reimbursement methodology used by hospitals and payer PBMs
• Site of care restrictions (hospital outpatient vs inpatient vs home infusion, if applicable)

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How do pricing and contracting dynamics affect Yorvipath net sales versus list price?

Hospital contracting and reimbursement gravity

For acute, specialty-use drugs, net pricing outcomes depend on:

• Hospital group purchasing agreements and carve-outs
• Patient-level rebates tied to formulary position
• Outcomes and utilization-based contracting structures

Commercial leakage points that typically lower net revenue

Key risk points for realized revenue:

• Delayed therapy start due to administrative authorization
• Non-formulary placement causing substitution with alternative agents
• Denials that force patient funding or late-stage transitions

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When did Yorvipath enter the market, and how do launch timing and uptake patterns map to financial trajectory?

Launch curve mechanics for specialty drugs

Yorvipath’s revenue path is expected to show:

• Ramp volatility early due to clinician adoption and ordering protocols
• Concentration of use in high-volume treating centers
• Stepwise sales changes following payer acceptance and formulary inclusion

Milestone-driven utilization

Sales growth is typically segmented by:

• Initial onboarding of specialty pharmacy or infusion partners
• Inclusion on payer formularies
• Streamlined procurement and therapy initiation workflows at treating sites

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How does competition in the eflornithine/acute parasitic treatment space impact market share and revenue?

Substitution risk from alternative regimens

Where alternative treatments exist, competitive pressure typically manifests through:

• Clinician preference based on perceived efficacy, dosing complexity, and monitoring burden
• Payer mandates favoring a preferred regimen
• Rapid switching during treatment protocols if response metrics are tracked

Competitive economics beyond efficacy

Even when clinical performance is comparable, competitors can win via:

• Lower administrative friction (faster authorization, fewer steps)
• Better contracting terms with institutional purchasers
• Greater availability through established distribution channels

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What is the financial trajectory outlook for Yorvipath under different payer-adoption scenarios?

Base-case revenue shape for narrow-use specialty therapies

A narrow indication usually produces:

• Limited upside from broad formulary expansion
• More revenue sensitivity to center of excellence adoption
• Higher dependence on patient identification workflows than on consumer-style demand

Downside dynamics

Revenue degradation tends to come from:

• Denials and delays that reduce treated volume
• Formulary exclusion that raises switching costs
• Competitive capture of early-treatment pathways

Upside dynamics

Revenue expansion is most likely from:

• Broadening institutional adoption in high-volume centers
• Improving access through payer policy changes and faster approvals
• Contracting improvements that move Yorvipath into preferred status

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What role do wholesalers, specialty distribution, and site-of-care choices play in Yorvipath sales performance?

Specialty distribution constraints

Yorvipath’s sales are shaped by:

• Order-to-infusion timing and logistics readiness
• Cold-chain or handling requirements if applicable
• Specialty pharmacy capacity and infusion center scheduling

Site-of-care economics

Shifts in site of care change revenue recognition economics through:

• Differing reimbursement rates and bundled payment rules
• Inventory risk at the hospital vs distributor level
• Different prior auth requirements depending on the care setting

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How do manufacturing capacity, supply continuity, and lead times affect revenue for Yorvipath?

Supply interruption as a sales limiter

Acute therapies generate tight demand windows. Supply shocks translate into:

• Missed treatment opportunities
• Contractual penalties in some hospital purchasing arrangements
• Lost formulary credibility if stock-outs occur

Procurement lead-time effects

Revenue outcomes are sensitive to:

• Distributor allocation decisions
• Hospital receiving lead times
• Forecast accuracy for short, urgent treatment cycles

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What regulatory or label-expansion events could change Yorvipath commercial trajectory?

Label breadth and off-protocol use

Commercial growth accelerates when:

• Indication is expanded to additional populations
• Clinician guidance broadens eligible use cases
• Evidence supports broader clinical protocols

Product lifecycle events

Sales can improve when:

• Administration method is simplified
• Dosing and monitoring requirements reduce clinician burden
• Adherence to protocol becomes less complex operationally

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What patents or exclusivity issues govern Yorvipath’s long-term pricing power and generic risk?

Patent and exclusivity overhang

Pricing power for branded specialty drugs depends on:

• Composition of matter protection
• Formulation and method-of-use patents
• Regulatory exclusivities (if any) that delay competitive entry

Generic and biosimilar-equivalent risk framing

For non-biologics, the risk pathway typically runs through:

• ANDA with paragraph IV challenges (where patent frameworks exist)
• At-risk launch if settlement or statutory stays permit

Net effect on long-term financial trajectory

When patent barriers weaken:

• Net pricing pressure usually appears first through formulary and procurement renegotiation
• Volume shifts follow as substitution becomes standard

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What patent litigation and settlement dynamics should investors track for Yorvipath?

Typical litigation-to-market pathways

Key economic impacts include:

• Time to final resolution affecting at-risk generic entry timing
• Consent to terms that influence exclusivity end dates
• Exclusivity or licensing agreements that can stabilize brand revenue temporarily

Economic indicators to monitor

• Court or PTAB milestones that shift likelihood of entry
• Settlement terms tied to launch date or market allocation
• Any “carve-out” coverage that limits the scope of generic substitution

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What is the Orange Book status of Yorvipath and how does it map to generic entry timelines?

Orange Book-driven entry calendar

Orange Book listings typically drive:

• Earliest permissible ANDA approval dates
• Statutory exclusivity windows
• Patent expiration-driven risk points for label protection

How to interpret entry risk for a narrow-use drug

Even if generic timelines appear feasible, realized competitive impact can be delayed by:

• Hospital procurement cycles and contract durations
• Physician preference inertia and protocol standardization
• Evidence requirements that shift usage slowly

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Which companies participate in Yorvipath’s competitive set, and how do their products affect market economics?

Competitive landscape segmentation

Competitive threats usually come from:

• Direct regimen competitors within the same therapeutic need
• Alternative dosing forms that reduce operational burden
• Market entrants with stronger formulary positioning

How to benchmark competitor economics

Track:

• Contracting stance (preferred access)
• Acquisition or distribution reach
• Availability through major hospital group purchasing channels

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What revenue exposure does Yorvipath have across geographies, and how does regional demand change financial outcomes?

Geographic sensitivity

For geographically concentrated diseases, sales are dominated by:

• Incidence density and public health capacity
• Treatment infrastructure and hospital referral networks
• Reimbursement structures and government procurement rules

Cross-border effects

Exports and regional procurement often create:

• Budget-cycle timing effects
• Tender-based revenue volatility
• Distributor or government agency payment timing differences

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How strong is Yorvipath’s commercial defensibility versus lower-cost alternatives?

Defensibility checklist

Commercial defenses typically include:

• Evidence-based clinical positioning
• Institutional protocol integration
• Contractual and formulary entrenchment
• Operational advantages in administration or monitoring

Where cost pressure appears

Cost pressure shows up when:

• Payer formulary committees revisit value based on outcomes data
• Generic or alternative regimens become accessible
• Procurement shifts to lowest net price under budget constraints

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Key Takeaways

• Yorvipath’s market dynamics are dominated by narrow eligible patient populations, urgent treatment workflows, and institutional access pathways rather than broad demand elasticity.
• Net revenue is most sensitive to payer authorization friction, formulary status, and site-of-care reimbursement rules.
• Competitive pressure will show up first through contracting and access, then through volume substitution across treating centers.
• Long-term pricing power depends on the durability of patent and exclusivity protections that govern generic entry timing and at-risk launch windows.

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FAQs

1. What drives Yorvipath uptake at hospital sites more than clinical considerations?
Payer authorization speed, formulary positioning, and operational integration into infusion workflows are the main drivers.

2. How does site-of-care selection typically change net revenue for specialty acute therapies like Yorvipath?
Reimbursement methodology and prior authorization requirements differ by inpatient versus outpatient versus specialty infusion settings, shifting net margins.

3. What is the main economic impact of manufacturing supply disruption for urgent therapies?
Stock-outs convert into missed treatment opportunities and formulary credibility losses, which reduce both volume and contracting leverage.

4. When does generic or alternative entry usually start pressuring Yorvipath pricing?
Pricing pressure often starts at contract renegotiation and formulary review, before large-scale volume switching occurs.

5. How do geographic treatment infrastructure differences influence Yorvipath revenue?
Higher referral density and hospital readiness increase identified cases and administered volume, while weaker infrastructure limits treated patient throughput.

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References

1. APA/Orange Book status sources are typically maintained by FDA under the Drugs@FDA and Orange Book databases; no Yorvipath-specific bibliographic entries were provided in the prompt.
2. FDA Drugs@FDA and the Orange Book are the authoritative sources for exclusivity and patent listing timelines; no direct Yorvipath listing identifiers were provided in the prompt.