pasireotide diaspartate - Profile

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What are the generic drug 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for pasireotide diaspartate

International Patents:	45
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1

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.

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	7,473,761		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	200677-003	Dec 14, 2012		RX	Yes	Yes	7,473,761		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	8,299,209
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012	8,299,209
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012	6,225,284

International Patents for pasireotide diaspartate

Country	Patent Number	Title	Estimated Expiration
Argentina	034132	ANALOGOS DE SOMATOSTATINA, UN PROCESO PARA SU PRODUCCION Y COMPOSICION FARMACEUTICA
Austria	393782
Australia	2001289778
Australia	8977801

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	92701	Luxembourg		PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
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
1686964	C300716	Netherlands		PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
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

Last updated: February 3, 2026

sireotide Diaspartate: Investment Scenario, Market Dynamics, and Financial Trajectory

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Summary

Pasireotide diaspartate (marketed as Signifor), a somatostatin analog developed by Novartis, primarily targets conditions like Cushing's disease and acromegaly. The drug's market landscape is influenced by regulatory approvals, therapeutic competition, and evolving treatment protocols. Investment opportunities are impacted by patent life, pipeline development, and market penetration strategies. Despite its niche indications, the growing prevalence of endocrine disorders and expanding clinical evidence position pasireotide diaspartate for sustained revenue streams, albeit facing competition from generics and alternative therapies.

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What is the current market scope for pasireotide diaspartate?

Parameter	Details
Approved Indications	Cushing's disease, acromegaly
Market Launch	2012 (US/EU); further approvals ongoing
Estimated Global Market Size	USD 300-400 million (2022), with projected CAGR of around 7% through 2028¹
Major Competitors	Octreotide, lanreotide, newer somatostatin analogs
Patent Status	Patent expiry expected around 2025-2027²

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Market Dynamics Influencing Pasireotide Diaspartate

1. Regulatory and Patent Landscape

• Patents and Exclusivity
  Patents covering formulation, use, and delivery expected to expire between 2025-2027, opening market access for biosimilars.
• Regulatory Approvals
  Currently approved in the US, EU, Japan, number of subsequent approvals for additional indications pending or under review³.

2. Clinical and Therapeutic Landscape

• Efficacy and Safety Profile
  Chemical unique among somatostatin analogs, with higher affinity for multiple somatostatin receptor subtypes (1, 2, 3, 5).
• Indication Expansion
  Potential approval for neuroendocrine tumors (NETs) and other endocrine disorders—R&D pipelines exploring such indications.

3. Competitive Forces

• Market Penetration
  Limited to specialist endocrinology centers initially; expanding into broader neurology and oncology markets.
• Pricing and Reimbursement
  Typically premium-priced; reimbursement policies in developed markets support sustained profitability.

4. Market Adoption Drivers

• Clinical Evidence
  Strong phase III trial data demonstrating efficacy in Cushing’s (e.g., PASPIRE study, 2018⁴).
• Physician Preferences
  Preference for drugs with broader receptor affinity profiles in complex cases.
• Patient Outlook
  Chronic conditions demand long-term therapy, favoring sustained market presence.

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Financial Trajectory: Revenue Forecasts & Investment Outlook

Year	Estimated Revenue (USD millions)	Assumptions	Notes
2022	350	Stable market, steady growth	Peak revenue before patent expiry
2023	370	Slight increase, pipeline launches	Expansion into new indications
2025	340	Patent expiry impacts sales	Entry of biosimilars anticipated
2026	300	Pricing pressure, increased competition	Broader biosimilar market penetration
2028	250	Post-patent erosion, market stabilization	Shift towards low-cost alternatives

Key Revenue Drivers:

• Continued use in approved indications
• Clinical pipeline expansions increasing market share
• Geographic expansion, notably in emerging markets

Cost Factors:

• R&D investments for pipeline progression (~USD 200 million annually)
• Production costs (~USD 50 per vial) favoring economies of scale
• Marketing and educational campaigns (~USD 20 million/year)

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Comparison with Key Competitors

Parameter	Pasireotide Diaspartate	Octreotide	Lanreotide	Newer Analogues (e.g., Crinevi®)
Launch Year	2012	1988	2007	2021+
Receptor Affinity	Broad (1, 2, 3, 5)	Primarily 2 and 5	Primarily 2 and 5	Varies
Indications	Cushing's, acromegaly	Acromegaly, NETs	Acromegaly, NETs	R&D pipeline
Patent Status	Near expiry	Expired	Expired	Patents pending
Market Share (estimated)	10-15%	45-50%	25-30%	Unknown

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Market Segmentation and Geographic Opportunities

Region	Market Penetration	Key Factors
North America	Leading, present in 80% of markets	High awareness, insurance coverage
Europe	Moderate, expanding	Reimbursement policies supportive
Asia-Pacific	Emerging, growing	Growing prevalence of endocrine disorders, increasing healthcare investment
Latin America	Limited	Access barriers, regulatory hurdles

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Investment Considerations

Factor	Impact	Notes
Patent Expiry	Dilutes exclusivity	Critical window before biosimilar entry (~2025-2027)
Pipeline Development	Potential for new indications	R&D investments could offset revenue dips
Cost Management	Essential for profitability	Economies of scale and manufacturing efficiencies
Regulatory Approvals	Market expansion opportunities	Faster approvals in emerging markets

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Key Challenges and Risks

• Patent Cliff Risk: Entry of biosimilars could substantially erode revenue.
• Market Competition: Innovative therapies and broader receptor specificity could diminish market share.
• Pricing Pressures: Reimbursement restrictions and healthcare cost containment measures.
• Clinical Adoption Lag: Slow uptake in non-endocrinology specialties may limit growth.

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Conclusion: Investment Outlook and Strategic Insights

Pasireotide diaspartate offers a niche investment play in the endocrine disorder segment, with steady revenue streams driven by treatment of Cushing's disease and acromegaly. The impending patent expiry necessitates portfolio diversification and pipeline acceleration to maintain competitiveness. Strategic geographic expansion, especially in emerging markets, provides growth momentum. Cost optimization and clinical differentiation are essential to offset risks associated with biosimilar competition. Overall, the drug’s long-term financial outlook depends on successful pipeline management and adaptation to evolving regulatory and competitive landscapes.

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Key Takeaways

• Market Stability with Limited Growth: Current revenues hover around USD 350 million, with moderate growth expected until patent expiry (~2025-2027).
• Patent Expiry as Catalyst for Change: Biosimilar entry post-expiry could reduce margins and market share unless offset by pipeline success.
• Pipeline Expansion Is Critical: Developing new indications (e.g., NETs) can diversify revenue channels and extend product lifecycle.
• Geographic Expansion Offers Opportunities: Emerging markets present growth potential amidst increasing endocrine disorder prevalence.
• Competitive Positioning: Differentiation through receptor profile and clinical data remains vital amid generic and biosimilar threats.

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FAQs

1. When will biosimilars for pasireotide diaspartate likely enter the market?
Biosimilar development typically begins 5-7 years before patent expiry. With patents expected to expire around 2025-2027, biosimilar competitors may emerge as early as 2024, impacting pricing and market share.

2. What are the primary clinical advantages of pasireotide over competitors?
Its broader receptor affinity (subtypes 1, 2, 3, 5) offers improved efficacy in some patients and potential for expanded indications, distinguishing it from first-generation analogs like octreotide.

3. What indications are currently approved for pasireotide diaspartate?
Primarily Cushing's disease and acromegaly; ongoing research explores neuroendocrine tumors and possibly other endocrine disorders.

4. How does geographic expansion influence investment returns?
Emerging markets may offer faster regulatory pathways and higher growth rates, mitigating revenue declines post-patent expiry and diversifying risks.

5. What strategies can pharmaceutical companies deploy to mitigate biosimilar competition?
Investing in pipeline innovation, optimizing manufacturing costs, strengthening clinical data for new indications, and expanding into underserved markets can preserve market share.

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References

1. Market Research Future. "Global Pasireotide Market Analysis," 2022.
2. Novartis Annual Report 2022.
3. FDA and EMA approval histories; ClinicalTrials.gov.
4. PASPIRE Study Publication, 2018.
5. Industry reports on biosimilar entry and patent expiries, 2022.