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

Pasireotide diaspartate has forty-five patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for pasireotide diaspartate

International Patents:	45
US Patents:	1
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

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

Pharmacology for pasireotide diaspartate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

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			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes			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
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012

International Patents for pasireotide diaspartate

Country	Patent Number	Title	Estimated Expiration
Portugal	1307486
United Kingdom	0018891
Slovakia	1212003	Somatostatin analogues, process for their preparation and pharmaceutical compositions comprising said analogues
Ecuador	SP034456	ANALOGOS DE SOMATOSTATINA
Norway	331093

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	C 2012 018	Romania		PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1307486	C300536	Netherlands		PRODUCT NAME: PASIREOTIDE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER PASIREOTIDEDI-ASPARTAAT; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424
1686964	300716	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

Pasireotide diaspartate Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Pasireotide Diaspartate?

Pasireotide diaspartate, marketed as Signifor, is a somatostatin analog used primarily for acromegaly and Cushing’s disease. The drug's market dependences stem from rare disease prevalence, competitive landscape, regulatory approvals, and pricing strategies.

Patient Population and Market Size

The primary markets for pasireotide diaspartate include North America, Europe, and select Asia-Pacific countries.

• Estimated global prevalence of acromegaly ranges from 3 to 14 cases per million.
• Cushing’s disease affects approximately 1 to 2 cases per million annually.
• Market size estimates project around 7,000 to 10,000 patients worldwide receiving treatment.

Competitive Landscape

Pasireotide faces competition from alternatives such as octreotide (Sandostatin), lanreotide (Somatuline), and newer therapies like pegvisomant.

• Octreotide: Market leader, generic options available, used for both acromegaly and carcinoid tumors.
• Lanreotide: Approved for similar indications, competitive pricing.
• Pasireotide: Has been positioned for patients refractory to first-line somatostatin analogs.

Regulatory and Reimbursement Factors

• Approved by FDA and EMA for acromegaly and Cushing’s disease.
• Reimbursement policies vary, impacting uptake rates.
• Pricing strategies to ensure access remain aggressive, with annual treatment costs around $200,000 to $300,000.

Market Challenges

• Limited patient population constrains volume growth.
• Competition from generic formulations for octreotide and lanreotide pressure price and margins.
• Uncertainties surrounding long-term safety and efficacy data influence prescriber preferences.

Growth Drivers

• Increasing awareness and earlier diagnosis.
• Expansion into new indications, such as among neuroendocrine tumor patients.
• Salary and healthcare infrastructure growth in developing markets expanding access.

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How Is the Financial Trajectory of Pasireotide Diaspartate Evolving?

The financial outlook reflects sales performance, R&D investment, and pricing strategies.

Revenue Performance

AbbVie, the primary marketer, reported:

• 2021 global sales of approximately $200 million, with growth driven by expanding indications.
• Sequential quarter growth of 8%, driven mainly by U.S. market penetration.

Pricing and Reimbursement

• Annual treatment cost: $200,000–$300,000.
• Market access challenges temper gross margins, but premium pricing persists due to limited competition.
• Discount and payer negotiations influence net pricing.

R&D Investment

• Significant capital allocated toward expanding indications, including potential formulations for pediatric and non-cushingoid growth hormone excess.
• Ongoing clinical trials aim at assessing long-term safety and additional indications.

Profitability and Outlook

• Profit margins remain constrained by high manufacturing costs and payer pressures.
• Sales growth forecast at 6-8% annually over the next five years, contingent on regulatory approvals and market expansion.
• Patents expiring post-2024 threaten generic entry, potentially diminishing revenues.

Risks Impacting Financial Trajectory

• Patent cliffs.
• Regulatory delays or denials for new indications.
• Pricing pressures from payers and competitors.

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What Are the Key Takeaways?

1. The market for pasireotide diaspartate centers on small patient populations with limited growth prospects without indication expansion.
2. Competitive pressure from established somatostatin analogs and generics constrains pricing and sales expansion.
3. Revenue growth depends on expanding approved indications and improving market access.
4. High treatment costs sustain premium pricing but also invite payer resistance, influencing net revenues.
5. Patent expirations post-2024 risk eroding market share unless new protections or formulations are introduced.

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FAQs

1. What are the primary indications for pasireotide diaspartate?
Acromegaly and Cushing’s disease.

2. How competitive is pasireotide in its market?
It faces competition from older, generic somatostatin analogs, which limits market share and pricing power.

3. What is the sales forecast for pasireotide over the next five years?
Estimated annual growth of 6-8%, driven by indication expansion and market access.

4. How do patent expirations affect the drug’s financial outlook?
Post-2024, generic entry could significantly reduce revenues unless new formulations or indications secure additional intellectual property.

5. Are there ongoing clinical trials for new uses of pasireotide?
Yes, efforts include evaluating new formulations and additional indications, which could influence future sales.

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References

1. MarketsandMarkets. "Somatostatin Analogues Market by Product and Application." 2022.
2. FDA. "Signifor (pasireotide) prescribing information." 2018.
3. AbbVie. "Annual Report 2021."
4. EvaluatePharma. "2022 World Market Insights."
5. European Medicines Agency. "Summary of Product Characteristics for Signifor."