SIGNIFOR Drug Patent Profile

When do Signifor patents expire, and when can generic versions of Signifor launch?

Signifor is a drug marketed by Recordati Rare and is included in two NDAs. There are four patents protecting this drug.

This drug has eighty-seven patent family members in thirty-nine countries.

The generic ingredient in SIGNIFOR is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Signifor

Signifor was eligible for patent challenges on December 14, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 14, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIGNIFOR

International Patents:	87
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	8
Patent Applications:	266
Drug Prices:	Drug price information for SIGNIFOR
What excipients (inactive ingredients) are in SIGNIFOR?	SIGNIFOR excipients list
DailyMed Link:	SIGNIFOR at DailyMed

See drug prices for SIGNIFOR

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

NDA:

200677

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 SIGNIFOR

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

Sponsor	Phase
University Hospital Heidelberg	PHASE2
University of Colorado, Denver	Phase 1
Hospices Civils de Lyon	Phase 2

See all SIGNIFOR clinical trials

Pharmacology for SIGNIFOR

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for SIGNIFOR

SIGNIFOR is protected by two US patents.

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
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No			Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes			Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		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 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

Expired US Patents for SIGNIFOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	200677-002	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 SIGNIFOR

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

Country	Patent Number	Title	Estimated Expiration
Austria	438659
United Kingdom	9600429
Hungary	0300684
Cyprus	1108547
Brazil	9609335	ANÁLOGOS DE SOMATOSTATINA, BEM COMO COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO OS MESMOS.
Ecuador	SP034456	ANALOGOS DE SOMATOSTATINA
Poland	1648934

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1307486	418	Finland
1307486	92024	Luxembourg		92024, EXPIRES: 20260730
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
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	CA 2012 00024	Denmark
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012

Market Dynamics and Financial Trajectory for Signifor (Pasireotide)

Last updated: December 27, 2025

Executive Summary

Signifor (pasireotide) is a somatostatin receptor ligand developed by Novartis for the treatment of acromegaly and Cushing's disease. Since its approval in multiple jurisdictions, the drug has experienced fluctuating market dynamics driven by factors including disease prevalence, competitive landscape, regulatory status, and emerging biosimilars. This report offers a comprehensive analysis of Signifor’s current market position, growth prospects, revenue trajectory, and strategic considerations for stakeholders.

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What is Signifor and How Does It Function?

Aspect	Details
Generic Name	Pasireotide
Pharmacological Class	Somatostatin analog
Indications	- Acromegaly (FDA approved in 2014) - Cushing's disease (FDA approved in 2016)
Mechanism of Action	Binds to somatostatin receptor subtypes 1, 2, 3, and 5, inhibiting the secretion of growth hormone (GH) and adrenocorticotropic hormone (ACTH)

Note: Signifor represents a second-generation somatostatin analog with broader receptor affinity, offering advantages over past therapies like octreotide.

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Market Overview and Trends

Prevalence and Patient Demographics

Disease	Global Prevalence	Estimated Number of Patients	Key Markets
Acromegaly	60-70 per million	~200,000 (worldwide), with 20,000 active cases	US, EU, Japan, emerging markets
Cushing's Disease	10-15 per million	~45,000 globally, with 7,000 ongoing cases	US, EU, Japan

Market Drivers:

• Rising awareness and improved diagnostics.
• Better understanding of disease subtypes, leading to targeted therapy.
• Aging populations increasing the incidence of these neuroendocrine disorders.

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Competitive Landscape

Competitors	Key Drugs	Mechanism	Approval Year	Market Position
Octreotide (Sandostatin)	Octreotide LAR	Somatostatin analog	1988	Dominant, first-line therapy
Lanreotide (Somatuline)	Lanreotide	Somatostatin analog	2007	Market leader in some regions
Pasireotide (Signifor)	Pasireotide	Broader receptor affinity	2014	Niche, targeted markets
Ecosense (Ecosensor)	Pasireotide (biosimilar)	Biosimilar versions emerging	2020+	Emerging competitor

Note: Biosimilars could erode Signifor’s market share post-expiry of patents.

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Regulatory & Approval Landscape

Region	Approval Status	Key Regulatory Notes	Last Update
United States	Approved for acromegaly (2014), Cushing's (2016)	REMS program to mitigate hypoglycemia risk	2016+
European Union	Approved (2014 for acromegaly, 2018 for Cushing's)	Market access driven by HTAs	2014–2018
Japan	Approved (2014)	Reimbursement status favorable	2014

Regulatory trends: Stringent safety and efficacy monitoring, especially concerning hyperglycemia risks.

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Financial Trajectory and Revenue Analysis

Historical Revenue Performance

Year	Revenue (USD millions)	Growth Rate	Notes
2014	$28M	N/A	Launch year, initial uptake
2015	$34M	+21%	Growing awareness & approvals
2016	$38M	+12%	Expanded indications
2017	$47M	+24%	Increased market penetration
2018	$43M	-8.5%	Rising competition & biosimilar threat
2019	$39M	-9.3%	Market saturation, pricing pressure
2020	$42M	+7.7%	Slight recovery; COVID-19 impact

Source: Novartis Annual Reports (2014–2020)

Revenue Drivers

• Market Penetration: Limited primarily to specialized neuroendocrinology centers.
• Pricing: Premium pricing supported by unique receptor profile but under pressure.
• Off-label Use: Limited due to safety concerns.
• Patient Compliance: Challenges due to injection frequency (monthly/quarterly) and side effects.

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Forecasted Financial Trajectory

Year	Projected Revenue (USD millions)	Assumptions
2023	$45M	Steady market, slight growth from innovations or expanded indications
2024	$47M	Potential impact of biosimilars, new formulations
2025	$50M	Possible market expansion, pipelines, or combination therapy approvals

These projections assume no major regulatory setbacks and steady market adoption.

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Emerging Strategic Trends Impacting Signifor

Trend	Impact
Biosimilar Entry	Risks market share erosion once patents expire (~2025–2027)
Combination Therapies	Potential to integrate Signifor with other targeted therapies
New Formulations	Development of long-acting or oral formulations to improve adherence
Regulatory Shifts	Increased demands for real-world evidence, safety profile enhancements

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Comparison with Market Alternatives

Parameter	Signifor	Octreotide (Sandostatin)	Lanreotide (Somatuline)
Receptor Affinity	Broad (subtypes 1,2,3,5)	Subtype 2	Subtype 2
Approval Year	2014	1988	2007
Efficacy	Comparable, with some evidence of superior receptor targeting	Well-established	Proven efficacy
Dosing Frequency	Monthly, adjustable	Monthly	Monthly
Side Effects	Hyperglycemia, gastrointestinal	Similar	Similar
Pricing	Premium	Lower	Lower

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Key Regulatory & Policy Factors Impacting Signifor Trajectory

Policy Area	Impact on Market Dynamics	Notable Examples
Pricing & Reimbursement	Price caps, reimbursement cuts could limit profitability	US CMS, EU national bodies
Intellectual Property	Patent expirations could lead to biosimilar competition	Patent expiry estimates (2025–2027)
Access & Distribution	Limitations in emerging markets may hinder growth	GHS policies, country-specific hurdles
Post-Market Surveillance	Stringent safety requirements may influence utilization	REMS programs

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Future Outlook & Strategic Considerations

• Growth Opportunities:

  • Expansion into new indications, such as neuroendocrine tumors.
  • Development of oral or long-acting formulations.
  • Strategic partnerships for biosimilar development pre-patent expiry.

• Challenges:

  • Patent cliff anticipated around 2025–2027.
  • Increasing biosimilar competition.
  • Side effect profile management, especially hyperglycemia.

• Potential Strategies:

  • Differentiation through combination therapies.
  • Cost optimization for wider access.
  • Investment in real-world evidence to bolster market confidence.

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Key Takeaways

• Signifor has established a niche in the treatment of acromegaly and Cushing's, with steady but moderate revenue growth driven by disease prevalence and approval expansions.
• Its broad receptor binding offers certain efficacy advantages, but competition from octreotide and lanreotide remains significant.
• Biosimilar entries, expected around 2025, pose a substantial threat to revenue, necessitating strategic innovation.
• The global market opportunities are expanding, notably with increasing diagnosis rates and emerging markets, though pricing pressures persist.
• Future success hinges on pipeline advancements, formulation innovations, and strategic positioning ahead of patent expirations and biosimilar proliferation.

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Frequently Asked Questions (FAQs)

1. When is Signifor expected to face biosimilar competition, and how will it impact revenues?
Biosimilars for pasireotide are anticipated around 2025–2027, coinciding with patent expiration. Historically, biosimilar entry leads to erosion of 20–40% of revenue in other biologics within 1–2 years, emphasizing the need for Novartis to develop next-generation formulations and alternative revenue streams.

2. How does Signifor compare to octreotide in terms of efficacy and safety?
Clinical data suggests Signifor may offer superior efficacy in certain patient subsets due to broader receptor affinity. However, it has a higher incidence of hyperglycemia and gastrointestinal side effects. Cost and dosing convenience also favor octreotide in some markets.

3. What are the key drivers for Signifor’s future growth?
Expansion into new indications, innovation in delivery methods, strategic partnerships, and early adoption in emerging markets are vital for sustained growth over the next five years.

4. How do regulatory policies affect Signifor’s market potential?
Stringent safety monitoring and reimbursement policies can limit patient access and profitability. Conversely, supportive policies promoting orphan drug status or compassionate use can enhance market penetration.

5. What role does patient adherence play in Signifor’s market trajectory?
Injection frequency and side effect profile influence adherence. Innovations like long-acting formulations could improve compliance, thereby expanding market size and revenue stability.

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References

[1] Novartis Annual Reports (2014–2020).
[2] FDA Clinical Review Documents for Signifor Approvals.
[3] Global Burden of Disease Studies on Acromegaly and Cushing's Disease.
[4] Market Research Reports from IQVIA and EvaluatePharma (2022).
[5] Regulatory and HTA policies from EMA, FDA, and respective national agencies.

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This detailed analysis aims to assist stakeholders in making informed strategic and investment decisions regarding Signifor’s market positioning and future trajectory.