Pasireotide pamoate - Generic Drug Details

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

Pasireotide pamoate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide pamoate has one hundred and thirty-five patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for pasireotide pamoate

International Patents:	135
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
DailyMed Link:	pasireotide pamoate at DailyMed

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

Dosage:

FOR SUSPENSION;INTRAMUSCULAR

^*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.

Anatomical Therapeutic Chemical (ATC) Classes for pasireotide pamoate

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes			Y	Y

Expired US Patents for pasireotide pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014

International Patents for pasireotide pamoate

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0112859	análogos de somatostatina, composição farmacêutica, bem como uso dos referidos análogos
Poland	1686964
Mexico	PA03000991	ANALOGOS DE SOMATOSTATINA. (SOMATOSTATIN ANALOGUES.)
Austria	455537

Supplementary Protection Certificates for pasireotide pamoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	2012/027	Ireland		PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424
1307486	SPC/GB12/030	United Kingdom		PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1307486	12C0041	France		PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424
1686964	15/2015	Austria		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/12/753/001-017 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2014) 8916 20141119

Market Dynamics and Financial Trajectory for Pasireotide Pamoate

Last updated: July 29, 2025

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Introduction

Pasireotide pamoate, a long-acting somatostatin analogue, has carved a niche within the pharmaceutical landscape primarily for its role in managing acromegaly and Cushing’s disease. As a potent inhibitor of hormone secretion, it offers distinct advantages over first-generation agents, creating robust market opportunities. Analyzing its market dynamics and financial trajectory involves understanding regulatory pathways, competitive landscape, patient demand, and pricing considerations.

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Pharmaceutical Profile and Therapeutic Positioning

Pasireotide pamoate is a sustained-release formulation delivering a quarterly or bi-monthly dosing schedule. Its mechanism fundamentally involves binding somatostatin receptor subtypes, especially SST5, to suppress excessive hormone secretion indicative of acromegaly and Cushing’s syndrome (as per [1]). The drug's pharmacokinetic profile heightens adherence by reducing administration frequency, a key driver of patient compliance. Its efficacy in controlling hormonal levels underscores its therapeutic positioning compared to oral or short-acting injectable competitors.

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Market Dynamics

1. Unmet Medical Needs and Market Drivers

Despite advances in neuroendocrine tumor management, acromegaly and Cushing’s disease remain challenging, with delayed diagnoses and suboptimal treatment responses. Pasireotide’s capacity to induce biochemical remission in resistant cases (notably in patients refractory to first-generation somatostatin analogues) creates demand. The first commercial successes of pasireotide in the US and Europe, notably marketed as Signifor LAR, demonstrate its pivotal role in niche indications.

Furthermore, the drug’s potential extends into expanding indications. Research into its utility for neuroendocrine tumors and as part of combination therapy could bolster market size. Growing awareness of acromegaly and Cushing’s disease, combined with the increasing emphasis on personalized medicine, amplifies demand for targeted therapies like pasireotide pamoate.

2. Competitive Landscape and Market Share

The competitive landscape is characterized by first-generation somatostatin analogues—octreotide (Sandostatin, Sandostatin LAR) and lanreotide (Somatuline Depot)—which dominate market share due to established safety profiles and longstanding clinical use. However, pasireotide's unique receptor affinity profile offers superior control in certain subsets, especially in cases resistant to traditional agents.

Biotech firms developing next-generation therapies, including GLP-1 analogues and alternative receptor modulators, pose potential competitive threats. Nevertheless, patent exclusivity and clinical data continue to sustain pasireotide’s market position.

3. Regulatory and Reimbursement Environment

Regulatory bodies have approved pasireotide for specific indications, but approval expansion could enhance its market footprint. Reimbursement policies significantly influence adoption; favorable insurance coverage and inclusion in clinical guidelines propel utilization. Conversely, high drug costs and stringent payer criteria threaten access.

In regions like the U.S., reimbursement complexities influence financial outcomes, as Medicare and private insurers evaluate cost-effectiveness alongside clinical benefits. In Europe, national health systems' reimbursement decisions similarly shape market penetration.

4. Pricing Strategies and Market Penetration

Pasireotide’s pricing reflects its status as a specialized, high-cost therapy. The drug’s long-acting formulation enables premium pricing, especially in cases requiring sustained hormonal suppression. Negotiations with payers and formulary placements directly impact sales volume.

Introduction of biosimilars or generics, anticipated beyond patent expiry, could instigate price competition, significantly altering revenue streams.

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Financial Trajectory

1. Revenue Projections and Growth Drivers

Initially launched in early 2010s, pasireotide exhibited steady revenue growth driven by:

• Expansion of approved indications: Additional approvals in resistant acromegaly cases and potential labels for Cushing’s disease.
• Geographic expansion: Entry into emerging markets with growing healthcare infrastructure and increasing disease awareness.
• Patient population growth: Rising prevalence of neuroendocrine tumors and acromegaly, driven partly by aging populations.

Analysts project compound annual growth rates (CAGR) between 5-10% for licensed markets through 2025, contingent upon regulatory and reimbursement developments.

2. Research & Development and Pipeline Potential

Pipeline diversification, including formulations with improved delivery mechanisms or combination regimens, aims to extend product lifecycle and mitigate generic threats. Investment in biomarker-driven clinical trials for broader indications nexus growth with personalized medicine trends.

3. Market Challenges and Financial Risks

Major risks include:

• Patent expiration: Potential generic entry diminishes revenue streams.
• Competitive innovations: New agents with better efficacy or safety profiles threaten current market share.
• Pricing pressures: Payer negotiations and governmental cost-containment policies impact profitability.
• Regulatory hurdles: Delays or rejections for new indications or formulations may stall revenue expansion.

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Emerging Trends and Market Opportunities

Digital Health and Data Integration: Incorporating real-world evidence and digital monitoring tools can demonstrate clinical and economic benefits, facilitating favorable reimbursement.

Biomarker Development: Personalized approaches targeting patient subgroups with specific receptor expression profiles can optimize efficacy and justify premium pricing.

Market Expansion: Entry into adjacent territories, including the Middle East and Asia Pacific, offers substantial revenue levers as healthcare infrastructure develops.

Partnerships and Licensing Agreements: Alliances with regional distributors and biotech firms can accelerate adoption and mitigate market-entry risks.

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Conclusion

Pasireotide pamoate’s market dynamics hinge on its clinical niche, evolving regulatory landscape, competitive pressures, and pricing strategies. Its financial trajectory exhibits promising growth potential, especially if marketed effectively to broaden indications and geographic reach. However, it must navigate patent expirations, price negotiations, and pipeline challenges to sustain long-term profitability.

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Key Takeaways

• Strategic positioning as a long-acting, targeted therapy solidifies pasireotide’s role in resistant acromegaly and Cushing’s disease.
• Market growth depends on expanding indications, geographic penetration, and favorable reimbursement environments.
• Competitive landscape remains robust, with first-generation analogues and pipeline innovations influencing market share.
• Pricing and patent considerations are pivotal; biosimilars could disrupt revenue streams post-patent expiry.
• Investment in clinical development and health economics evidence will be crucial to securing regulatory approval for new indications and ensuring reimbursement.

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FAQs

1. What are the primary therapeutic indications for pasireotide pamoate?
Pasireotide pamoate is primarily approved for treating acromegaly refractory to or unsuitable for surgery or other medical therapies, and for Cushing’s disease in cases where surgery is not feasible or effective.

2. How does pasireotide differ from first-generation somatostatin analogues?
It has higher affinity for certain somatostatin receptor subtypes, notably SST5, which can improve hormonal control in resistant cases and provide superior efficacy in some patient subsets.

3. What are the main factors influencing its market success?
Regulatory approvals, reimbursement policies, clinical trial data demonstrating superiority in resistant cases, pricing strategies, and market expansion efforts are key drivers.

4. What is the potential impact of biosimilar entry on pasireotide’s revenues?
Biosimilars could significantly reduce market prices and volume, leading to decreased revenues unless the original product sustains competitive advantages or lines of indication.

5. What future developments could expand pasireotide’s market?
Broader regulatory approvals, new formulations with improved delivery, expansion into additional neuroendocrine tumor treatments, and integrating digital health solutions could enhance its market presence.

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References

[1] Melmed, S. et al. (2014). "Pasireotide: A Next-Generation Somatostatin Receptor Ligand." Endocrine Reviews, 35(3), 356–385.