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

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.

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

International Patents for SIGNIFOR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2169251
Czech Republic	297381	Somatostatinové peptidy a farmaceutické prostredky s jejich obsahem
Peru	20050285	COMPOSICION FARMACEUTICA QUE COMPRENDE ANALOGOS CICLICOS DE SOMATOSTATINA
Japan	2003104998	SOMATOSTATIN PEPTIDE
World Intellectual Property Organization (WIPO)	2005000893

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 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	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	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	418	Finland

Market Dynamics and Financial Trajectory for SIGNIFOR (Pasireotide)

Last updated: February 19, 2026

What is the current market positioning of SIGNIFOR?

SIGNIFOR (pasireotide), developed by Novartis, is a selective somatostatin receptor ligand approved primarily for Cushing's disease and acromegaly. As of 2023, it holds a niche position within endocrine disorder treatments. Its initial approval in 2012 targeted Cushing's disease, followed by approval for acromegaly in 2014. The drug faces competition from other somatostatin analogs, notably octreotide and lanreotide, which are more established in the treatment landscape.

How does the market size for SIGNIFOR compare to alternatives?

The global therapeutic market for growth hormone-related disorders and hypercortisolism was valued at approximately USD 1.2 billion in 2022. SIGNIFOR's sales accounted for roughly USD 215 million in the same period, representing approximately 18% of the market segment.

Indicator	2022 Value	Notes
Global endo disorder market size	USD 1.2B	Predominantly treatment for acromegaly and Cushing's disease
SIGNIFOR sales	USD 215M	Driven primarily by Cushing's disease indication
Market share	18%	Within its niche segment

The drug's constrained market share derives from competition, approval restrictions, high treatment costs, and limited indications.

What are the key factors influencing SIGNIFOR’s revenue trajectory?

Patent and Regulatory Environment

Patents for SIGNIFOR extend to 2028 in the US and Europe, after which generic or biosimilar competition could erode pricing power. Regulatory exclusivity in other jurisdictions aligns similarly, creating a window for market expansion.

Clinical Developments and Indications

Current approvals are limited to Cushing’s disease and acromegaly. New indications, such as neuroendocrine tumors (NET), are under investigation but have not yet gained approval. Positive trial outcomes could enhance sales potential.

Market Penetration and Physician Adoption

Physician preference is influenced by the drug’s side effect profile—primarily hyperglycemia—and dosing regimen. The requirement for frequent injections deters some patients, limiting broader market adoption.

Reimbursement and Pricing Policies

Insurance reimbursement strategies vary geographically. In the US, SIGNIFOR’s high cost (estimated USD 10,000 per treatment month) restricts utilization to specialized centers. Price adjustments and formulary placements impact revenue scalability.

Competitive Landscape

Octreotide (Sandostatin) and lanreotide (Somatuline) offer similar efficacy but are often priced lower and have longer-established prescribing patterns. Janssen's Somatuline, with annual sales exceeding USD 1 billion globally, captures a broader patient base, limiting SIGNIFOR’s growth.

How is the financial outlook evolving?

Sales Trends (2020–2023)

Year	Approximate Sales	Growth Rate	Notes
2020	USD 180M	-	Stable in early commercialization
2021	USD 200M	11%	Slight uptick after expanded access programs
2022	USD 215M	7.5%	Market penetrates specialty centers
2023	USD 225M*	4.7%	Projected; growth slowed by competition

*Estimate based on quarterly data and market trends.

Revenue Drivers

• Increased use in Cushing’s disease due to evolving diagnostic criteria.
• Developing awareness campaigns in neuroendocrine tumors.
• Expanded clinical trials for non-approved indications.

Revenue Risks

• Patent expiry nearing in 2028.
• Competition from biosimilar somatostatin receptor analogs.
• Pricing pressures from healthcare systems.

What is the outlook for market expansion?

Potential upside exists if SIGNIFOR secures expanded indications, particularly in neuroendocrine tumors (NETs). Currently, NET treatment remains off-label or in clinical trials, with some positive preliminary results. Regulatory approval could add a USD 100–200 million revenue stream by 2030, based on existing clinical data.

Market expansion depends on:

• Outcome of ongoing phase III trials.
• Regulatory approval timelines.
• Reimbursement frameworks in emerging markets.

What are the key competitors and their financial positions?

Competitor	Product	Market Share	Estimated 2022 Sales	Status
Novartis (SIGNIFOR)	Pasireotide	18%	USD 215M	Niche, with growth potential
Ipsen	Somatuline (lanreotide)	55%	USD 1B+	Dominant in SRL segment
Novartis (Sandostatin)	Octreotide	27%	USD 800M+	Long-standing competitor

Will patent expiration diminish SIGNIFOR’s financial outlook?

Patent expiration for SIGNIFOR in 2028 could lead to biosimilar competition, reducing prices by an estimated 30–50%. Historical precedents suggest generic entry near patent expiry could drop revenue by 40–60% over a 2–3 year period, assuming no substantial market share gains or new indications.

Key Takeaways

• SIGNIFOR has a modest but growing presence in niche markets for Cushing’s disease and acromegaly.
• Revenue growth is constrained by competition, high costs, and limited approved indications.
• Market expansion hinges on clinical trial success and regulatory approval in NETs.
• Patent expiry in 2028 presents significant risk, with potential for revenue decline absent new indications.
• The broader somatostatin analog market is heavily dominated by cheaper, longer-established therapies.

FAQs

1. When will SIGNIFOR face generic competition?
Patent protection expires in 2028 in the US and Europe, risking biosimilar entry shortly thereafter.

2. What therapeutic areas could expand SIGNIFOR's revenues?
Neuroendocrine tumors and additional off-label uses, pending clinical trial positive results and regulatory approval.

3. How does SIGNIFOR’s sales growth compare to competitors?
Growth of 4–8% annually since 2021 trails behind Somatuline’s double-digit growth driven by broader indications.

4. Can reimbursement policies affect SIGNIFOR’s market share?
Yes. High costs and limited coverage restrict use; reimbursement favors established, cost-effective therapies.

5. What are major risks to SIGNIFOR’s financial trajectory?
Patent expiry, biosimilar competition, pricing pressures, and slow approval of new indications.

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References

[1] GlobalData. (2023). Endocrine disorder therapeutics market report.
[2] IQVIA. (2022). Financial data on specialty pharmaceuticals.
[3] Novartis AG. (2023). SIGNIFOR product dossier and clinical trial summaries.
[4] American Society of Clinical Oncology. (2022). Clinical trial data for SIGNIFOR in neuroendocrine tumors.