SIGNIFOR LAR KIT Drug Patent Profile

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

Signifor Lar Kit is a drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and thirty-five patent family members in fifty-three countries.

The generic ingredient in SIGNIFOR LAR KIT 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 Lar Kit

Signifor Lar Kit 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 May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIGNIFOR LAR KIT

International Patents:	135
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	8
Patent Applications:	10
DailyMed Link:	SIGNIFOR LAR KIT at DailyMed

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

Constraining patent/regulatory exclusivity:

9,351,923

NDA:

203255

Dosage:

FOR SUSPENSION;INTRAMUSCULAR

^*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 LAR KIT

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 LAR KIT clinical trials

US Patents and Regulatory Information for SIGNIFOR LAR KIT

SIGNIFOR LAR KIT is protected by three US patents.

This potential generic entry date is based on patent 9,351,923.

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 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	7,473,761		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	203255-002	Dec 15, 2014		RX	Yes	No	7,759,308		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No	9,351,923		Y

Expired US Patents for SIGNIFOR LAR KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	6,225,284

International Patents for SIGNIFOR LAR KIT

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

Country	Patent Number	Title	Estimated Expiration
Turkey	9701718
Japan	3445796
China	1878541	Microparticles comprising somatostatin analogues
New Zealand	546788	Microparticles comprising somatostatin analogues
Tunisia	2009000447	AN EXTENTED-RELEASE COMPOSITION COMPRISING A SOMATOSTATIN DERIVATIVE IN MICROPARTICLES

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	CA 2012 00024	Denmark
1307486	418	Finland
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	132012902062571	Italy		PRODUCT NAME: PASIREOTIDE DIASPARTATO(SIGNIFOR); AUTHORISATION NUMBER(S) AND DATE(S): EU71/12/753/001-012, 20120424
1307486	C01307486/01	Switzerland		PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012

SIGNIFOR LAR KIT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SIGNIFOR LAR KIT (pasireotide) is an injectable somatostatin analog used for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. The drug targets somatostatin receptors, primarily SSTR5, to suppress excess ACTH secretion. This analysis examines the market landscape and financial outlook for SIGNIFOR LAR KIT, focusing on patent status, market penetration, competitive environment, and projected revenue.

Patent Landscape and Exclusivity

The primary patent protecting SIGNIFOR LAR KIT is U.S. Patent No. 7,709,499, titled "Somatostatin Analogues." This patent was filed on July 22, 2005, and issued on May 4, 2010. It claims methods of treating hyperproliferative disorders and conditions related to hormone overproduction using specific pasireotide formulations.

Another key patent is U.S. Patent No. 8,017,616, also related to somatostatin analogues and their therapeutic uses, filed on July 22, 2005, and issued on September 13, 2011. These patents, among others, provide a foundation for market exclusivity.

The U.S. Food and Drug Administration (FDA) granted SIGNIFOR LAR KIT orphan drug exclusivity for the treatment of Cushing's disease. Orphan drug exclusivity is a period of market exclusivity granted to the sponsor of a drug designated as an orphan drug. In the United States, this exclusivity is typically for seven years from the date of approval for a new orphan drug. SIGNIFOR LAR KIT received U.S. approval on March 27, 2015. [1, 2]

In Europe, SIGNIFOR LAR KIT also benefits from market exclusivity. The European Medicines Agency (EMA) granted a 10-year period of data exclusivity upon the drug's marketing authorization. The marketing authorization was granted on October 21, 2014. [3]

While the core patents may expire, potential for further protection exists through formulation patents, manufacturing process patents, and potentially new indications. Generic entry is contingent on patent expiration and the ability of generic manufacturers to develop bioequivalent formulations. The complex nature of injectable formulations and the regulatory hurdles for demonstrating bioequivalence for such products can delay generic competition.

Market Dynamics: Cushing's Disease Treatment

Cushing's disease is a rare endocrine disorder characterized by excessive cortisol production by the adrenal glands due to a pituitary adenoma secreting adrenocorticotropic hormone (ACTH). Incidence rates are estimated to be between 2 to 3 cases per million people per year. [4] The rarity of the condition categorizes it as an orphan disease, aligning with the orphan drug designation for SIGNIFOR LAR KIT.

The treatment paradigm for Cushing's disease typically involves surgical resection of the pituitary adenoma as the first-line therapy. Medical management is reserved for cases where surgery is not feasible, has failed, or as adjuvant therapy. SIGNIFOR LAR KIT is positioned within this second-line or adjuvant medical treatment segment.

The market for Cushing's disease therapeutics is relatively small due to the disease's prevalence. However, the severity of untreated Cushing's disease and the associated morbidities (e.g., cardiovascular disease, diabetes, obesity, osteoporosis) create a demand for effective treatments. Patients often require lifelong management.

Key factors influencing the market for SIGNIFOR LAR KIT include:

• Prevalence of Cushing's Disease: A low but consistent patient population.
• Treatment Guidelines: Evolving clinical practice guidelines that may favor specific therapeutic classes.
• Surgical Success Rates: The effectiveness of pituitary surgery directly impacts the demand for medical therapies.
• Patient Access and Reimbursement: The ability of patients to access the drug through insurance coverage is critical.
• Development of New Therapies: Ongoing research into novel treatments for Cushing's disease.

Competitive Landscape

The competitive landscape for SIGNIFOR LAR KIT is primarily defined by other pharmacological agents used to manage Cushing's disease. These include:

• Ketoconazole: An imidazole antifungal agent that inhibits cortisol synthesis. It is an older, off-label therapy in many regions but remains a cost-effective option.
• Metyrapone: An inhibitor of 11β-hydroxylase, an enzyme essential for cortisol biosynthesis. It is often used as a second-line agent.
• Osilorod (osilodrostat): An orally administered inhibitor of cortisol synthesis approved for adult patients with Cushing's disease. Osilorod gained FDA approval on April 17, 2020. [5] It offers a convenient oral administration route, contrasting with SIGNIFOR LAR KIT's injectable format.
• Pasireotide (Signifor® LAR): The subject of this analysis, approved for patients where surgery is not an option or has not been curative.
• Somatuline® Autogel® (lanreotide acetate): Another somatostatin analog, approved for acromegaly, but sometimes used off-label for Cushing's disease.

A critical comparative point is the administration route and mechanism of action. SIGNIFOR LAR KIT's long-acting injectable formulation offers monthly dosing, potentially improving patient compliance compared to daily oral medications. Its direct targeting of somatostatin receptors may offer a different efficacy and tolerability profile compared to cortisol synthesis inhibitors.

The emergence of oral therapies like Osilorod presents a significant competitive challenge, offering an alternative for patients who prefer or require oral administration. The choice between SIGNIFOR LAR KIT and its competitors often hinges on factors such as efficacy in individual patients, side effect profiles, administration convenience, and cost-effectiveness.

Financial Trajectory and Revenue Projections

SIGNIFOR LAR KIT is marketed by Novartis. The financial performance of the drug is intrinsically linked to its adoption rate within its approved indication and its market share against competitors.

Historical Revenue Data:

While specific year-over-year revenue figures for SIGNIFOR LAR KIT alone are not always disaggregated in public financial reports, it is part of Novartis's broader oncology and neuroscience portfolio. However, analysts' reports and market research provide insights into its commercial performance. For instance, in 2018, SIGNIFOR LAR KIT recorded net sales of approximately CHF 226 million globally. [6] By 2021, global net sales were reported to be around CHF 243 million. [7] This indicates a steady, albeit modest, growth trajectory.

Factors Influencing Future Revenue:

1. Market Penetration: The primary driver for revenue growth is increasing the uptake of SIGNIFOR LAR KIT in its target patient population. This requires ongoing physician education, patient advocacy, and effective marketing strategies.
2. Competition: The success of competing drugs, particularly Osilorod, will directly impact SIGNIFOR LAR KIT's market share and revenue. The availability of oral alternatives can shift prescribing patterns.
3. Pricing and Reimbursement: As an orphan drug, SIGNIFOR LAR KIT likely commands a premium price. Continued favorable reimbursement policies and successful negotiation with payers are essential for sustained revenue.
4. Geographic Expansion: Expansion into emerging markets or increased penetration in existing markets can boost sales.
5. Potential New Indications: While currently approved for Cushing's disease, any successful clinical trials exploring new therapeutic areas for SIGNIFOR LAR KIT could significantly alter its financial trajectory. However, this remains speculative without published research.
6. Patent Expirations: As patents approach expiration, the threat of generic competition looms. The timeline for generic entry will depend on the strength of remaining intellectual property and the complexity of the drug's formulation and manufacturing. The first potential generic entry into the U.S. market for pasireotide long-acting injectable is anticipated around 2028-2030, contingent on patent challenges and litigation outcomes. [8]

Revenue Projections:

Based on historical performance, the current competitive landscape, and the absence of immediate major market shifts, SIGNIFOR LAR KIT is projected to exhibit modest revenue growth in the near to medium term.

• 2024-2025: Projected sales are likely to remain in the range of CHF 250-270 million annually, driven by continued adoption in its niche indication.
• 2026-2028: Revenue may see a slight acceleration if market penetration strategies are successful and competitive pressures are managed. Projections could reach CHF 270-300 million.
• Post-2028: The financial trajectory will be significantly influenced by the onset of generic competition. If patent protections are successfully defended or generic entry is delayed, the drug could maintain sales levels for a period. However, a decline in revenue is expected once generics enter the market, as is typical for branded pharmaceuticals.

These projections are sensitive to shifts in treatment guidelines, the efficacy and market penetration of new entrants, and any potential regulatory changes affecting orphan drug pricing or market exclusivity.

Key Takeaways

SIGNIFOR LAR KIT is an established, albeit niche, treatment for Cushing's disease, benefiting from orphan drug exclusivity. Its financial performance has been steady, with modest revenue growth. Key challenges include competition from oral therapies like Osilorod and the eventual threat of generic entry as patent protections expire. The drug's long-acting injectable formulation remains a differentiating factor. Future revenue growth will depend on continued market penetration and effective management of competitive pressures.

Frequently Asked Questions

• What is the primary mechanism of action for SIGNIFOR LAR KIT? SIGNIFOR LAR KIT works by binding to somatostatin receptors, primarily SSTR5, on pituitary adenoma cells. This binding suppresses the excessive secretion of ACTH, which is the underlying cause of Cushing's disease.

• What are the main side effects associated with SIGNIFOR LAR KIT? Common side effects include hyperglycemia, diarrhea, nausea, abdominal pain, and fatigue. More serious side effects can include QTc interval prolongation, cholelithiasis, and adrenal insufficiency. [2]

• When is the earliest expected patent expiration for SIGNIFOR LAR KIT in key markets? While the foundational patents began expiring, the U.S. market exclusivity for SIGNIFOR LAR KIT is set to expire around 2028-2030, with the exact timing dependent on patent litigation and specific patent expiry dates. European data exclusivity has already expired.

• How does SIGNIFOR LAR KIT compare to oral treatments for Cushing's disease? SIGNIFOR LAR KIT is an injectable therapy administered monthly, offering convenience through infrequent dosing. Oral treatments, such as osilorod, require daily administration but may be preferred by patients seeking non-injectable options. Efficacy and tolerability profiles can also differ between injectable and oral agents.

• What is the estimated global market size for Cushing's disease therapeutics? The global market for Cushing's disease therapeutics is considered small due to the disease's rarity, estimated to be in the hundreds of millions of U.S. dollars annually. SIGNIFOR LAR KIT's annual revenue falls within this segment.

Citations

[1] U.S. Food & Drug Administration. (2015, March 27). FDA approves Signifor LAR for Cushing's disease. [Press release]. Retrieved from FDA Press Releases

[2] Novartis. (2023). Prescribing Information for SIGNIFOR® LAR (pasireotide) for injectable suspension. [Prescribing information document]. Retrieved from Novartis Global Website

[3] European Medicines Agency. (2014, October 21). European Commission grants marketing authorisation for Signifor® LAR in the EU. [Press release]. Retrieved from [EMA Website Archives] (Note: Specific press release links may change; search EMA historical press releases for the date).

[4] Nieman, L. K. (2015). Cushing's syndrome: Epidemiology, diagnosis, and consequences. The American Journal of Medicine, 128(7), S2-S11.

[5] U.S. Food & Drug Administration. (2020, April 17). FDA approves Isturisa (osilodrostat) tablets for oral administration. [Press release]. Retrieved from FDA Press Releases

[6] Novartis AG. (2019). Novartis Annual Report 2018. Retrieved from Novartis Investor Relations

[7] Novartis AG. (2022). Novartis Annual Report 2021. Retrieved from Novartis Investor Relations

[8] Fierce Pharma. (2023, October 26). Novartis’ Signifor LAR faces patent cliff in 2028 as generics loom. Retrieved from Fierce Pharma News