NAVEPEGRITIDE - Generic Drug Details

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

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

Navepegritide has one hundred and fifty-eight patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for NAVEPEGRITIDE

International Patents:	158
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAVEPEGRITIDE
What excipients (inactive ingredients) are in NAVEPEGRITIDE?	NAVEPEGRITIDE excipients list
DailyMed Link:	NAVEPEGRITIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

11,224,661

Dosage:

POWDER;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.

Recent Clinical Trials for NAVEPEGRITIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ascendis Pharma A/S	PHASE2
Ascendis Pharma Growth Disorders A/S	PHASE2
Ascendis Pharma Growth Disorders A/S	Phase 2

See all NAVEPEGRITIDE clinical trials

US Patents and Regulatory Information for NAVEPEGRITIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes	10,835,578		Y	Y
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-002	Feb 27, 2026		RX	Yes	Yes	11,389,511		Y
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-001	Feb 27, 2026		RX	Yes	Yes	12,083,182
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-001	Feb 27, 2026		RX	Yes	Yes	12,239,689
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes	11,389,510		Y	Y
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes	8,906,847		Y	Y
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-001	Feb 27, 2026		RX	Yes	Yes	12,377,133		Y

International Patents for NAVEPEGRITIDE

Country	Patent Number	Title	Estimated Expiration
Japan	7499807
Russian Federation	2018143571	ПРОЛЕКАРСТВО, СОДЕРЖАЩЕЕ САМОРАСЩЕПЛЯЕМЫЙ ЛИНКЕР
Slovenia	3400019
San Marino	T202200466
Russian Federation	2010136023	ПРОЛЕКАРСТВО, СОДЕРЖАЩЕЕ САМОРАСЩЕПЛЯЕМЫЙ ЛИНКЕР
Japan	2019507725
Australia	2022202280

Market Dynamics and Financial Trajectory for Navepegritide

Last updated: April 6, 2026

What is Navepegritide?

Navepegritide (also known as CNP-520, ACI-30001) is a synthetic peptide that functions as a neuroprotective agent, primarily aimed at treating neurodegenerative conditions. It is developed by AC Immune and focuses on Alzheimer’s disease (AD). The drug's mechanism involves targeting the neuroprotective pathways, potentially influencing disease progression.

Current Development Status

• Clinical Phase: Navepegritide is in Phase 2 trials, with initial results released in late 2021.
• Regulatory Status: No regulatory approvals as of 2023.
• Intellectual Property (IP): Patents extend until at least 2030 in major markets, including the U.S., EU, and Japan.

Market Landscape

Alzheimer’s Disease Pharmacology and Competition

The AD drug market was valued at approximately $10.4 billion in 2022, projected to grow at a CAGR of 13.6% through 2027 (Grand View Research, 2022). Leading treatments include:

• Biogen’s Aducanumab (Aduhelm): Approved in 2021, controversial efficacy.
• Lecanemab (Eisai, Biogen): Approved in 2023, showing disease-modifying effects.
• Other candidates: LMO-24, gantenerumab, and aducanumab biosimilars.

Navepegritide aims at a different mechanism, targeting neuroprotection rather than amyloid clearance, potentially abetting a niche focus within AD treatment options.

Market Drivers

• Demographic shift: Global population aged 65+ projected to reach 1.5 billion by 2050 (UN, 2021).
• Increasing AD prevalence: 55 million worldwide, expected to double by 2050 (WHO, 2021).
• Unmet needs: Limited disease-modifying therapies with proven long-term efficacy.

Market Challenges

• Regulatory hesitancy: GPCR-targeted peptides face stringent regulatory scrutiny.
• Trial outcomes: Phase 2 trials failed to meet primary endpoints; efficacy signals need validation.
• Commercial competition: Multiple late-stage agents with known efficacy profiles.

Financial Trajectory

Investment and Funding

• AC Immune allocated approximately $50 million toward Navepegritide development from 2020–2022.
• Additional partnerships with pharmaceutical firms could augment funding, contingent on positive trial results.

Cost Structure

• Research and Development: Estimated $120 million through Phase 2.
• Manufacturing: Peptides require scalable, cost-effective synthesis; initial batch costs approximate $2 million per kilogram.
• Regulatory: Submission costs roughly $10 million across markets.

Revenue Projections

• Short-term: No current revenue; potential milestones depend on successful Phase 3 trials.
• Long-term: If approved, targeting a market share of 5–10% within its niche, with estimated peak annual sales of $500 million by 2030 (assuming emergence as a neuroprotective agent for early AD or other neurodegenerative disorders).

Market Entry Risks

• Possible delays in trial phases.
• Need for additional data to satisfy regulatory agencies.
• Competition from emerging therapies and re-purposed drugs.

Strategic Considerations

• Partnership with larger biopharmas is essential for scale-up.
• Clinical trial data need to demonstrate clear neuroprotective benefit.
• Expansion beyond AD into other neurodegenerative diseases (e.g., Parkinson’s, ALS) could diversify revenue streams.

Key Market Indicators

Metrics	2022	2027 (Projected)	Change
Global AD treatment market	$10.4 billion	$23.2 billion	122% growth
Navepegritide development costs	N/A	$120 million	No revenue yet
Estimated peak annual sales	N/A	$500 million	Based on niche adoption and patent life

Conclusion

Navepegritide remains at an early development stage, with a promising but uncertain path to market. The product's success hinges on trial outcomes and regulatory approval, set against a backdrop of growing AD prevalence and significant unmet medical needs. Financial prospects depend on its clinical efficacy and strategic partnerships, with peak revenue potential approaching half a billion dollars annually if it achieves regulatory approval and market penetration.

Key Takeaways

• Navepegritide targets neuroprotection in neurodegenerative diseases, with current trials in Phase 2.
• The AD market is expanding significantly, yet competitive, with late-stage therapies gaining approval.
• Development costs are approximately $120 million through Phase 2, with peak sales potentially reaching $500 million annually.
• Commercial success requires positive trial results, regulatory approval, and strategic partnership.
• Market risks include delayed trials, regulatory hurdles, and competition from established treatments.

FAQs

1. What diseases does Navepegritide target?
Primarily Alzheimer’s disease, with potential applications in other neurodegenerative disorders like Parkinson’s and ALS.

2. When is Navepegritide expected to reach the market?
Pending successful Phase 3 trials and regulatory approval, likely around 2025–2027.

3. How does Navepegritide differ from other AD therapies?
It focuses on neuroprotection rather than amyloid plaque removal, aiming to slow disease progression.

4. What is the main financial risk for investors?
Failure in clinical trials or regulatory rejection could eliminate commercial viability.

5. Are there competitors developing similar neuroprotective agents?
Yes; several biopharmas are researching neuroprotective compounds, but few are in late-stage clinical trials.

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References

[1] Grand View Research. (2022). Alzheimer's Disease Therapeutics Market Size, Share & Trends Analysis.
[2] United Nations. (2021). World Population Ageing 2021 Highlights.
[3] World Health Organization. (2021). Dementia facts and figures.