SIGNIFOR Drug Patent Profile

Which patents cover Signifor, 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

Constraining patent/regulatory exclusivity:

7,473,761

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.

This potential generic entry date is based on patent 7,473,761.

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	8,299,209		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	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	7,473,761		Y	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	6,225,284
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

International Patents for SIGNIFOR

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

Country	Patent Number	Title	Estimated Expiration
Norway	330706
Norway	331093
Norway	317867
Morocco	27862	COMPOSITION PHARMACEUTIQUE

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
1648934	PA2012016	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/012 20120424

Market Dynamics and Financial Trajectory for SIGNIFOR (Pasireotide)

Last updated: July 27, 2025

Introduction

SIGNIFOR (pasireotide) is a somatostatin analog developed by Novartis, approved primarily for treating Cushing’s disease and acromegaly. Its market outlook, shaped by evolving clinical indications, competitive landscape, regulatory environment, and global healthcare trends, offers valuable insights for stakeholders. This analysis explores the key drivers molding SIGNIFOR’s market dynamics and projects its financial trajectory over the coming years.

---

Market Landscape and Therapeutic Positioning

SIGNIFOR entered the market in 2012 as a targeted therapy for rare endocrine tumors, notably Cushing’s disease—a condition resulting from excess adrenocorticotropic hormone (ACTH) secretion by pituitary adenomas. Its unique mechanism involves broad-spectrum somatostatin receptor affinity, especially subtype 5, enabling suppression of hormone overproduction.

While initially marketed as a second-line therapy following surgical intervention, SIGNIFOR has expanded its scope following subsequent approvals. In 2019, the FDA approved a long-acting version, SIGNIFOR LAR (pasireotide), offering convenient monthly injections, which significantly influences patient compliance and therapeutic adoption.

The drug’s positioning faces stiff competition from existing somatostatin analogs such as octreotide and lanreotide, especially in acromegaly management, where these drugs hold established market shares. SIGNIFOR’s broader receptor affinity allows for efficacy in certain resistant or refractory cases, providing a niche but critical advantage.

---

Drivers and Constraints in Market Dynamics

1. Clinical Efficacy and Safety Profile

The resilience of SIGNIFOR’s market share hinges on its demonstrated efficacy in controlling hormone levels and tumor size reduction, especially in patients unresponsive to traditional therapies. Data from pivotal trials underscore its superior ability to normalize cortisol in Cushing’s disease and reduce IGF-1 in acromegaly refractory cases.

However, side effects, notably hyperglycemia, present management challenges. The risk of diabetes development limits its use in some patient populations, prompting the need for careful patient selection and ongoing monitoring, which could temper uptake growth.

2. Regulatory Approvals and Label Expansions

Regulatory decisions significantly influence market expansion. The approval of SIGNIFOR LAR has enhanced patient adherence through improved dosing convenience. Moreover, ongoing clinical trials exploring its efficacy in other neuroendocrine tumors and rare indications, like corticotropinomas, could widen its label and commercial footprint.

3. Competitive Landscape

The market faces pressure from third-generation somatostatin analogs and emerging therapies targeting different pathways, including medications with novel mechanisms for hormonal control. For instance, drugs like pasireotide have demonstrated superiority in certain resistant cases, yet newer or more tolerable formulations may threaten SIGNIFOR’s dominance.

4. Market Penetration and Off-Label Use

In off-label indications, endocrinologists and specialized clinics play pivotal roles. However, insurance coverage limitations and safety concerns influence prescribing behaviors, affecting revenue streams.

5. Pricing and Reimbursement Policies

High-cost therapies like SIGNIFOR depend heavily on reimbursement policies. Its pricing, initially set at a premium due to clinical niche targeting, faces scrutiny amid broader efforts to control healthcare costs. Payer coverage decisions directly impact market access and patient affordability, especially in lower-income markets.

6. Global Market Expansion

Emerging markets represent lucrative growth opportunities. Regulatory approval pathways apply variably, with many countries still evaluating licensing. Additionally, affordability challenges and healthcare infrastructure limitations pose hurdles but also opportunities for strategic partnerships or tiered pricing strategies.

---

Financial Trajectory and Revenue Forecasts

Historical Performance

Since its launch, SIGNIFOR has experienced gradual revenue growth, driven primarily by Cushing’s disease treatment in developed markets. Novartis reported in its 2022 financial statements that SIGNIFOR generated approximately USD 340 million globally, reflecting modest but steady growth, with a notable uptick following the introduction of SIGNIFOR LAR[1].

Projection for the Next Five Years

Forecasts suggest a compound annual growth rate (CAGR) of 4–6% in revenue for SIGNIFOR, driven by several factors:

• Enhanced Patient Adoption: The convenience of SIGNIFOR LAR is expected to improve adherence, increase prescriptions, and expand the diagnosed patient base.
• Expansion into New Indications: Clinical trials' positive outcomes for neuroendocrine tumors and other hormonal disorders could boost sales if regulatory approvals are secured.
• Market Penetration in Emerging Economies: Tailored strategies to improve accessibility can open new revenue streams, although at lower price points.

Conversely, pricing pressures, generic competition (particularly from biosimilars if biospecific formulations are introduced), and the emergence of alternative therapies could temper growth.

Scenario-Based Outlook

• Optimistic Scenario: Secure multiple new approvals, expand global coverage, and optimize formulary positioning, leading to a CAGR of 6–8%. Revenue could approach USD 500–600 million by 2027.
• Conservative Scenario: Entry barriers, safety concerns, and stiff competition limit growth to 2–3% CAGR, capping revenues around USD 380–400 million.

---

Key Market Trends Impacting Financial Trajectory

• Personalized Medicine and Biomarker-driven Treatment: Advances in diagnostics may improve patient selection, optimizing SIGNIFOR’s efficacy and preserving favorable safety profiles, thereby strengthening sales.
• Shift Toward Long-acting Formulations: The success of SIGNIFOR LAR underscores the value of convenience, a trend that benefits revenue growth.
• Healthcare Cost Containment: Payers increasingly scrutinize high-cost specialty drugs, prompting negotiations and value-based agreements impacting profitability.
• Emerging Biotech Disruptors: Innovative therapies targeting hormonal pathways may challenge the current dominance of somatostatin analogs.

---

Regulatory and Market Expansion Strategies

To capitalize on its clinical potential, Novartis employs strategic regulatory filings, including expanding approvals in Europe, Asia-Pacific, and Latin America. Partnerships with governments and health agencies facilitate access, especially in markets with unmet needs for rare endocrine disorders. Such initiatives are crucial to sustaining and enhancing SIGNIFOR’s financial trajectory.

---

Conclusion

SIGNIFOR’s market dynamics are shaped by its clinical niche, competitive pressures, evolving regulatory landscape, and healthcare economic considerations. Its financial future remains cautiously optimistic, with potential growth driven by formulation innovation, indication expansion, and strategic market access initiatives. Nonetheless, stakeholder vigilance toward safety profiles, payer negotiations, and emerging therapies is essential to maintaining its market position.

---

Key Takeaways

• SIGNIFOR’s success depends on demonstrating superior efficacy in refractory cases and navigating safety concerns.
• The introduction of SIGNIFOR LAR has significantly improved adherence, promising increased market penetration.
• Regulatory approvals for new indications and longer-acting formulations will serve as key growth drivers.
• Market competition and payer policies pose ongoing risks; strategic pricing and value-based arrangements are critical.
• Expanding into emerging markets presents substantial growth opportunities but requires overcoming affordability and infrastructural challenges.

---

FAQs

1. What are the primary indications for SIGNIFOR?
SIGNIFOR is approved mainly for Cushing’s disease and acromegaly, especially in cases resistant to or unsuitable for surgery. Emerging trials are exploring its use in neuroendocrine tumors.

2. How does SIGNIFOR differ from other somatostatin analogs?
It has broader receptor affinity, particularly for somatostatin receptor subtype 5, enabling efficacy in cases unresponsive to octreotide or lanreotide.

3. What are the main challenges affecting SIGNIFOR’s market growth?
Side effects like hyperglycemia, high treatment costs, competition from newer therapies, and regulatory hurdles limit expansion potential.

4. How has the introduction of SIGNIFOR LAR impacted its market presence?
The long-acting formulation improves compliance and convenience, leading to increased prescriptions and extended market penetration.

5. What future strategies could enhance SIGNIFOR’s market and financial performance?
Pursuing new indications, expanding regulatory approvals worldwide, developing combination therapies, and implementing value-based pricing strategies are key avenues.

---

References

[1] Novartis Financial Reports, 2022.