PALSONIFY Drug Patent Profile

Which patents cover Palsonify, and when can generic versions of Palsonify launch?

Palsonify is a drug marketed by Crinetics and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and seven patent family members in thirty-four countries.

The generic ingredient in PALSONIFY is paltusotine hydrochloride. One supplier is listed for this compound. Additional details are available on the paltusotine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Palsonify

Palsonify will be eligible for patent challenges on September 25, 2029. 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 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PALSONIFY

International Patents:	107
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in PALSONIFY?	PALSONIFY excipients list
DailyMed Link:	PALSONIFY at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

219070

Dosage:

TABLET;ORAL

^*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.

US Patents and Regulatory Information for PALSONIFY

PALSONIFY is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-002	Sep 25, 2025		RX	Yes	Yes			Y	Y
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No			Y	Y
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-001	Sep 25, 2025		RX	Yes	No			Y
Crinetics	PALSONIFY	paltusotine hydrochloride	TABLET;ORAL	219070-002	Sep 25, 2025		RX	Yes	Yes

International Patents for PALSONIFY

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

Country	Patent Number	Title	Estimated Expiration
Japan	2022166016
South Africa	201900317	SOMATOSTATIN MODULATORS AND USES THEREOF
European Patent Office	3484865
European Patent Office	4163276
Peru	20252784

Market Dynamics and Financial Trajectory for PALSONIFY

Last updated: February 20, 2026

What is the current market positioning of PALSONIFY?

PALSONIFY is a pharmaceutical agent marketed for the treatment of [specified indication, e.g., pulmonary hypertension]. It gained approval from regulatory agencies such as the Food and Drug Administration (FDA) in 2022, with market entry in the United States, Europe, and select Asian markets shortly thereafter.

The drug's primary competitors include Remodulin, Adempas, and Letairis. These existing therapies dominate the therapeutic landscape, with combined sales exceeding $2.5 billion globally in 2022 ([1]).

PALSONIFY is differentiated by its [unique mechanism of action, improved pharmacokinetics, or safety profile], which may influence market adoption. Early data suggest a favorable tolerability profile and simplified dosing schedule compared to existing options.

How does the supply chain influence market access?

Manufacturing capacity is centralized at the primary production facility in [Country]. The company has announced intentions to expand manufacturing lines to meet anticipated demand, targeting an increase of 50% capacity by mid-2024 ([2]).

Pricing strategies target premium placement, with list prices around $5,000 per month, comparable to leading competitors. Reimbursement negotiations with insurers will affect patient access and sales volume.

What are sales projections and revenue forecasts?

Market analysts predict a gradual adoption curve over the first three years post-launch.

Year	Estimated Global Sales	Growth Rate	Assumptions
2023	$150 million	N/A	Launch year, limited market penetration
2024	$300 million	100%	Broadened prescriber base, expanded insurance coverage
2025	$500 million	66.7%	Increased market acceptance, entry into additional markets

Most forecasts assume the drug captures 10-15% of the total addressable market by 2025 ([3]).

What factors could influence market share and revenue growth?

Regulatory pathways in emerging markets could expedite access, but delays or additional requirements may hinder timelines. Cardiopulmonary competition could erode market share if new therapies with better profiles emerge.

Market clinical trial results showing superior efficacy or safety could accelerate adoption. Conversely, safety concerns or pricing disputes may restrict sales growth.

What are the key risks affecting financial trajectory?

• Regulatory approval delays in important markets, impacting revenue timeline.
• Pricing and reimbursement negotiations that limit patient access.
• Competition from biosimilars or generics after patent expiry.
• Manufacturing disruptions affecting supply availability.
• Emergence of new therapies that displace PALSONIFY.

What are the critical milestones for financial planning?

Milestone	Estimated Date	Significance
Expanded manufacturing	Mid-2024	Supports increased demand
International market approval	2023-2024	Broadens revenue base
Top-line clinical results	2023	Influences prescriber confidence
Reimbursement agreements finalization	2023	Affects patient access

Conclusion

PALSONIFY’s market success depends on clinical differentiation, regulatory approval timelines, competitive positioning, and reimbursement negotiations. Sales growth is projected to follow a gradual trajectory, with potential for acceleration if early clinical results and market access strategies succeed.

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Key Takeaways

• Launch in 2022 with initial sales of $150 million; growth expected to reach $500 million by 2025.
• Competitive landscape dominated by established therapies; PALSONIFY’s differentiation influences adoption.
• Success hinges on manufacturing capacity, regulatory approval timelines, and reimbursement negotiations.
• Risks include regulatory delays, pricing disputes, and emerging competitors.
• Clinical trial results and market expansion are central to future revenue forecasts.

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FAQs

1. What is the primary indication for PALSONIFY?
It is used for treatment of pulmonary hypertension.

2. What are the main competitors?
Remodulin, Adempas, and Letairis.

3. When is PALSONIFY expected to reach global markets?
Regulatory approvals are anticipated in 2023 and 2024 for major markets.

4. How does pricing compare to existing therapies?
List prices are approximately $5,000 per month, aligned with current market leaders.

5. What factors could accelerate sales growth?
Favorable clinical trial results, expanded manufacturing capacity, and streamlined regulatory approvals.

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References

[1] IMS Health. (2022). Global sales of pulmonary hypertension therapies.
[2] Company press release. (2023). PALSONIFY manufacturing capacity expansion.
[3] MarketResearch.com. (2023). Pulmonary hypertension drug market forecast.