SIGNIFOR Drug Patent Profile

Which patents cover Signifor, and what generic alternatives are available?

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

This drug has forty-five patent family members in thirty-three 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:	45
US Patents:	1
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 one 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	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No	7,759,308		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No	7,759,308		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No	9,351,923		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	200677-002	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	200677-003	Dec 14, 2012	8,299,209
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	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	8,299,209

International Patents for SIGNIFOR

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	177097	SOMATOSTATIN PEPTIDES
Colombia	4700528	PEPTIDOS DE SOMATOSTATINA
World Intellectual Property Organization (WIPO)	0210192
Portugal	1648934
United Kingdom	9513224
Croatia	P20090571

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
1307486	2012C/026	Belgium		PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426
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
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

Market Dynamics and Financial Trajectory for SIGNIFOR

Last updated: March 31, 2026

What is SIGNIFOR?

SIGNIFOR (pasireotide) is a somatostatin analog approved by the FDA in 2012 for the treatment of Cushing’s disease in adults who cannot undergo surgery or whose disease persists post-surgery. Developed by Novartis, it targets excess cortisol production by inhibiting adrenocorticotropic hormone (ACTH) secretion.

Market Size and Growth Drivers

The global market for drugs treating Cushing’s disease and related conditions, such as acromegaly, was valued at approximately $350 million in 2022. SIGNIFOR accounts for a significant share, expected to expand at a compound annual growth rate (CAGR) of 7-10% through 2028, driven by:

• Unmet medical need: Limited treatment options for patients with persistent or recurrent disease.
• Increased diagnosis: Rising awareness leads to higher identification of Cushing’s disease.
• Expansion into new indications: Research into off-label uses and other hormone-related conditions.

Competitive Landscape

Key competitors include:

• Octreotide (Sandostatin): Similar mechanism but less effective for Cushing’s disease.
• Metyrapone and Ketoconazole: Off-label use to control cortisol levels but with safety concerns.
• Relacorilant: Under development; selective glucocorticoid receptor antagonist targeting Cushing’s symptoms.
• Ecopipam: Emerging, experimental therapy with a different mechanism.

SIGNIFOR’s market position hinges on its unique efficacy for refractory cases and limited oral alternatives.

Regulatory and Clinical Developments

Recent regulatory trajectories include:

• FDA approval extensions: For adjunctive use in selected cases.
• European Medicines Agency (EMA) approvals: Same indications, with increased coverage.
• Ongoing clinical trials: For indications like Nelson’s syndrome, and in pediatric cohorts.

The pivotal FALCON trial (ClinicalTrials.gov NCT02256763) evaluated efficacy and safety, consolidating SIGNIFOR’s position in refractory Cushing’s.

Revenue and Financials

Novartis generated approximately $85 million in sales of SIGNIFOR in 2022. Growth estimates project an increase to about $120 million by 2026, contingent on:

• Market penetration: Expanding healthcare provider adoption.
• Pricing strategies: Maintaining premium pricing based on clinical benefits.
• Regulatory approvals: Potential expansion into additional indications.

Price points average around $2,500 per 30-day supply (average wholesale price), with variations based on payer negotiations.

Pricing and Reimbursement Landscape

Significant reimbursement barriers include:

• High treatment costs: Reimbursements depend on insurance coverage and health systems.
• Cost-effectiveness: Demonstrated through clinical benefit rather than price reduction.
• Market access initiatives: Novartis invests in advocacy for better reimbursement coverage.

Patent Outlook and Biosimilar Threats

SIGNIFOR’s composition patent expired in 2021; however, Novartis holds secondary patents on manufacturing processes and formulations up to 2030. Biosimilars are likely to enter the market post-2024, exerting pressure on pricing and market share.

Strategic Opportunities

• Expansion into orphan and rare disease markets.
• Development of oral formulations: Historically limited by bioavailability, ongoing research could improve convenience and adherence.
• Combination therapies: Fixed-dose combinations with other hormones or receptor antagonists.

Risks and Challenges

• Market competition: Entry of biosimilars and generics post-2024.
• Regulatory hurdles: For new indications or formulations.
• Pricing pressures: Payer resistance to high-cost therapies.
• Clinical trial risks: Efficacy and safety concerns in extended populations.

Key Takeaways

• SIGNIFOR holds a niche in treating refractory Cushing’s disease, with potential for growth amid rising diagnosis rates.
• Revenue growth depends on expanding indications, market penetration, and biosimilar entry.
• Competitive landscape shifts with biosimilars and new drug candidates under development.
• The reimbursement environment is critical for sustainability, with pricing strategies influencing access.
• Patent expiries and biosimilar competition pose long-term risks.

FAQs

1. What are the main drivers of SIGNIFOR’s growth?
Increased diagnosis of Cushing’s disease, limited treatment options for resistant cases, and ongoing clinical trials for new indications.

2. How does SIGNIFOR compare to other therapies?
It is more effective for refractory cases compared to oral alternatives like octreotide, though it faces competition from emerging receptor antagonists and biosimilars.

3. What is the patent expiry timeline for SIGNIFOR?
Primary patents expired in 2021; secondary patents extend protection until around 2030.

4. What markets are most promising for SIGNIFOR?
North America and Europe, where reimbursement systems support high-cost orphan drugs; China and Japan are potential growth markets.

5. What clinical trials are shaping SIGNIFOR’s future?
Trials investigating efficacy for Nelson’s syndrome, pediatric Cushing’s, and expansion into acromegaly.

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References

[1] Novartis. (2023). SIGNIFOR (pasireotide) prescribing information.
[2] MarketWatch. (2022). Worldwide Cushing’s disease drug market analysis.
[3] ClinicalTrials.gov. (2023). Trial identifiers for ongoing studies involving SIGNIFOR.