Pasireotide diaspartate - Generic Drug Details

What are the generic sources for pasireotide diaspartate and what is the scope of freedom to operate?

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

Pasireotide diaspartate has eighty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for pasireotide diaspartate

International Patents:	87
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	1
Patent Applications:	777
DailyMed Link:	pasireotide diaspartate at DailyMed

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

Constraining patent/regulatory exclusivity:

7,473,761

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.

Recent Clinical Trials for pasireotide diaspartate

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

Sponsor	Phase
RECORDATI GROUP	PHASE2

See all pasireotide diaspartate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for pasireotide diaspartate

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 diaspartate

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	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	7,473,761		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	8,299,209		Y	Y

Expired US Patents for pasireotide diaspartate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012	6,225,284

International Patents for pasireotide diaspartate

Country	Patent Number	Title	Estimated Expiration
Iceland	2705
South Korea	20060035809
Ecuador	SP056237	COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE ANÁLOGOS DE SOMATOSTATINA CÍCLICOS
Australia	2004251866	Pharmaceutical composition comprising cyclic somatostin analogues
Malaysia	138074	SOMATOSTATIN ANALOGUES
Austria	438659
South Korea	101124136

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1307486	CR 2012 00024	Denmark		PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
1307486	418	Finland
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
1648934	PA2012016	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424
1307486	122012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424

Market Dynamics and Financial Trajectory for Pasireotide Dispositate

Last updated: July 28, 2025

Introduction

Pasireotide diaspartate, marketed under the brand name Signifor, is a potent somatostatin analog developed for the treatment of acromegaly and Cushing's disease. As a third-generation somatostatin receptor ligand (SRL), pasireotide exhibits broad receptor affinity, especially for somatostatin receptor subtype 5 (SSTR5), providing enhanced efficacy over earlier SRLs like octreotide and lanreotide. The drug's unique pharmacological profile and its clinical indications position it as a significant player within niche endocrinology markets. Analyzing the current market dynamics and financial trajectory of pasireotide diaspartate involves assessing regulatory, clinical, competitive, and commercial factors shaping its growth prospects.

Market Landscape and Demand Drivers

Clinical Indications and Market Size

Pasireotide primarily targets acromegaly and Cushing's disease—rare endocrine disorders characterized by excess hormone secretion, with estimated prevalences of approximately 40–50 per million for acromegaly and 39–40 per million for Cushing's disease globally [1][2]. The rarity of these conditions confers orphan drug status upon pasireotide, offering regulatory and market exclusivity benefits.

The global market for acromegaly therapeutics is valued at around USD 75-100 million annually, with expectations of growth fueled by increased diagnosis and therapeutic awareness [3]. Similarly, Cushing's disease market anticipates expansion, with estimates reaching USD 50-70 million annually, driven by ongoing unmet needs and the emergence of effective pharmacotherapies.

Market Penetration and Adoption Trends

Despite clinical efficacy, pasireotide's adoption remains constrained by several factors, including adverse event profiles—most notably hyperglycemia—and competition from established agents like octreotide and lanreotide. However, in patients resistant or intolerant to first-line SRLs, pasireotide offers a valuable alternative.

Pharmaceutical companies’ efforts to expand indications—such as treating neuroendocrine tumors (NETs)—are ongoing, broadening sales opportunities. Moreover, the progress in personalized medicine approaches, combining pasireotide with other agents, further enhances potential clinical applications.

Market Dynamics Influencing Growth

Regulatory Approvals and Labeling

Regulatory decisions significantly impact market potential. Pasireotide received FDA approval in 2012 for Cushing's disease and later for acromegaly in 2014. The label expansions and full regulatory acceptance in broader markets like the EU and Japan facilitate international commercialization.

Recent attempts by the manufacturer, Novartis, to secure expanded indications and dosing options aim to bolster sales. Regulator endorsements, coupled with orphan drug designations, create market exclusivities, enabling pricing power and investment incentives.

Pricing and Reimbursement Environment

Pricing strategies impact revenue streams profoundly. Pasireotide's list price surpasses USD 10,000 per month, aligning with other targeted endocrine therapies. Reimbursement challenges remain, especially in cost-sensitive healthcare systems, demanding strong health economics evidence to justify usage.

Health technology assessments (HTAs) scrutinize the drug's cost-effectiveness, influencing formulary inclusion. Managed entry agreements and risk-sharing schemes are increasingly employed to mitigate payer resistance.

Competitive Landscape

Pasireotide faces competition from:

• Octreotide and Lanreotide: First-generation SRLs with well-established safety profiles and widespread use.
• Molecular targeted agents: such as cabergoline and ketoconazole, utilized off-label or in specific scenarios.
• Emerging therapies: including newer SRLs or drug formulations under clinical trials, potentially disrupting current market shares.

Notably, its distinct receptor affinity and clinical profile make pasireotide favorable in resistant cases but less dominant in first-line settings.

Clinical Research and Pipeline Prospects

Ongoing clinical trials evaluating pasireotide in various indications, including neuroendocrine tumors and diabetic complications, could open additional avenues for growth. Positive trial outcomes could extend patent protections, expand label indications, and enhance market penetration.

Financial Trajectory and Revenue Projections

Historical Sales Performance

Since its initial launch, pasireotide's sales have been modest, constrained by the factors discussed. Bloomberg Intelligence reports indicate sales of approximately USD 200–300 million globally in 2021, with the U.S. contributing a significant portion due to its robust healthcare infrastructure and favorable regulatory landscape [4].

Sales growth demonstrates variability, impacted by healthcare provider familiarity, adverse event management, and payer coverage policies.

Future Revenue Potential

Projected revenue growth hinges on several variables:

• Market expansion: including approvals for additional indications and niche therapeutic use cases.
• Pricing strategies: adjustments in line with payer negotiations and value demonstration.
• Patent protection timetable: with key patents set to expire between 2024 and 2030, generic competition could erode margins.
• Pipeline developments: positive results in clinical trials could lead to new formulations or combination therapies, extending commercial viability.

Analysts forecast a compound annual growth rate (CAGR) of approximately 5–8% through 2025, contingent on successful market penetration and minimal generic competition.

Strategic Challenges and Opportunities

Challenges

• Adverse effect profile: hyperglycemia management remains critical; potential liability may limit broader application.
• Market entry barriers: entrenched competition and healthcare system reimbursement constraints.
• Patent expirations: increased risk of generic entries post-2024 diminish profitability.

Opportunities

• New indications: expanding into neuroendocrine tumors or other hormone-related conditions.
• Combination therapies: exploring synergies with other hormonal treatments.
• Biomarker-driven application: tailoring treatments to responsive patient subsets.
• Partnerships and licensing: leveraging collaborations for broader market access.

Conclusion

Pasireotide diaspartate occupies a niche yet strategically important position within the endocrinology pharmacotherapy landscape. Its sales and financial trajectory remain cautiously optimistic, conditioned by regulatory, clinical, and competitive factors. With targeted expansion efforts, ongoing clinical innovation, and effective management of adverse events, pasireotide's market presence and revenue streams are poised for modest but steady growth.

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Key Takeaways

• Pasireotide's principal market revolves around orphan indications such as acromegaly and Cushing's disease, with steady growth forecasts of 5–8% CAGR through 2025.
• Challenges include adverse effects like hyperglycemia and impending patent expirations; opportunities lie in expanding indications and combination therapies.
• Revenue is influenced heavily by payer reimbursement, regulatory approvals, and clinical adoption, with current sales estimated at USD 200–300 million globally.
• Strategic initiatives to demonstrate cost-effectiveness and broaden clinical utility are critical to maintaining competitiveness.
• Navigating competition and optimizing clinical outcomes will determine pasireotide's long-term financial trajectory.

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FAQs

1. What are the primary indications for pasireotide diaspartate?
Pasireotide is approved mainly for acromegaly and Cushing's disease, targeting hormone overproduction in these rare endocrine disorders.

2. How does pasireotide differ from first-generation somatostatin analogs?
It exhibits broader receptor affinity, especially for SSTR5, providing enhanced efficacy in patients resistant to other SRLs like octreotide.

3. What are the main challenges affecting pasireotide's market growth?
Key challenges include adverse effects (notably hyperglycemia), high treatment costs, competition from established therapies, and patent expiries that threaten exclusivity.

4. Could ongoing clinical trials expand pasireotide’s therapeutic applications?
Yes, trials exploring its use in neuroendocrine tumors and other hormone-related disorders may open new markets if successful.

5. What strategies can enhance pasireotide’s market penetration?
Approaches include indication expansion, demonstrating cost-effectiveness to payers, managing side effects effectively, and forming strategic collaborations to increase awareness and access.

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Sources:
[1] Shetty, N. et al., “Prevalence of Acromegaly and Cushing’s Disease,” Clin Endocrinol. 2021; [2] Food and Drug Administration (FDA), “Signifor (pasireotide) approval documents,” 2012; [3] Grand View Research, “Endocrine Disorder Therapeutics Market Analysis,” 2022; [4] Bloomberg Intelligence, “Pharmaceutical Market Outlook,” 2022.