SIGNIFOR LAR KIT Drug Patent Profile

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

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

US Patents and Regulatory Information for SIGNIFOR LAR KIT

SIGNIFOR LAR KIT is protected by three 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 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	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No			Y

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
Argentina	004497	UN ANÁLOGO HEXAPÉPTIDO CÍCLICO DE SOMATOSTATINA, PROCEDIMIENTO PARA PREPARARLOS Y LAS COMPOSICIONES FARMACÉUTICAS QUE LOS CONTIENEN Y EL USO DE DICHO HEXAPÉPTIDO PARA LA PREPARACIÓN DE UNA COMPOSICIÓN FARMACÉUTICA.
Austria	210152
Australia	6515096

Supplementary Protection Certificates for SIGNIFOR LAR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	CR 2015 00026	Denmark		PRODUCT NAME: PASIREOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET HVILKET SOM HELST HYDRAT DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753, C(2014)8916 20141121
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	2012C/026	Belgium		PRODUCT NAME: PASIREOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/753/001 20120426

SIGNIFOR LAR KIT (pasireotide) investment scenario and patent-IP fundamentals analysis for generics, biosimilar risk, and launch timing

Last updated: July 25, 2026

SIGNIFOR LAR KIT is Exelixis? No. It is a Novartis product (pasireotide) in a long-acting injectable formulation administered as a kit. The investment-relevant IP and competitive risk center on long-acting formulation protection, method-of-use protections tied to acromegaly and Cushing’s disease, and the absence of a biologics-style biosimilar pathway for a small-molecule peptide analog. The dominant downside risk for an investor underwriting prolonged cash flows is the combination of (1) near-term patent expiries for formulation or use claims and (2) the likelihood that any successful abbreviated application (including Paragraph IV for relevant listed patents) can shorten the time to market for a competing long-acting injectable.

What patents protect SIGNIFOR LAR KIT (pasireotide long-acting injection) and how strong is the patent estate?

Featured snippet answer: The protectable frontier for SIGNIFOR LAR is concentrated in (a) long-acting depot formulation and manufacturing methods for pasireotide as a sustained-release injectable and (b) method-of-use claims for treating acromegaly and Cushing’s disease with pasireotide. The investment strength depends on whether the remaining unexpired claims are formulation-centric (harder to design around) versus indication-centric (easier to bypass by not targeting the same labeled use).

Which legal claim types drive exclusivity for long-acting pasireotide?

Long-acting depot products typically show patent landscapes with three clusters that matter for generics:

1. Formulation and composition of matter

   • Drug product composition and polymer system, particle size/distribution, and depot-release profile.

2. Manufacturing and process patents

   • Sterile manufacturing steps, lyophilization (if any), mixing order, and controls that impact release kinetics and implant integrity.

3. Method-of-use and dosing regimen patents

   • Dosing frequency, dose-escalation schedules, patient selection parameters, and target outcomes.

Investment implication: process and formulation claims often increase IP barriers for a generic long-acting injectable, while narrow dosing or patient-selection claims can be avoided by changing the label, the regimen, or the clinical implementation.

How many patents cover SIGNIFOR LAR and where do they expire?

No complete, accurate patent list with expiration dates can be produced from the information provided in the prompt. A quantified patent-count and expiry timeline requires an Orange Book pull for US listed patents and a corresponding global patent register extract.

When does SIGNIFOR LAR lose exclusivity? What are the effective expiration dates for US exclusivity and patent life?

Featured snippet answer: For a marketed long-acting injectable, effective exclusivity is determined by the later of (a) US patent expirations for Orange Book–listed patents and (b) any regulatory exclusivity that attaches to the relevant NDA/BLA (typically tied to new chemical entity or new clinical investigation). The controlling risk for investment is the date when the last actively enforceable patent claim covering commercially relevant product attributes expires or is weakened by an adverse court ruling.

What US regulatory exclusivity usually matters for a small-molecule injectable?

For pasireotide products, investment timelines commonly hinge on:

• Patent expiry of formulation and method-of-use claims
• “Orange Book” listing status at the NDA level
• Any additional five-year exclusivity triggers tied to clinical investigations (if applicable to the specific NDA filing history)

No Orange Book status or exclusivity calculation can be completed without the NDA number and the currently listed patent set.

What generic entry risks exist for SIGNIFOR LAR KIT and how likely are Paragraph IV challenges?

Featured snippet answer: The key generic entry risk for SIGNIFOR LAR is a Paragraph IV challenge to one or more Orange Book–listed patents that cover the long-acting depot formulation or labeled indications. If a challenger’s certification targets the last-to-expire listed patent(s), the investor risk is reduced; if the remaining claims are weak or easily designed around, a generic can enter quickly after patent expiry or court invalidation.

What patents are Paragraph IV candidates for long-acting injectables?

Common Paragraph IV targets for long-acting injectable drug products include:

• Specific depot formulation compositions
• Release-control polymer systems
• Manufacturing steps affecting depot uniformity and release kinetics
• Method-of-use claims that track the label

Investment implication: a challenger can choose certifications to carve out claims not required to practice a generic product (for example, if only formulation patents remain, generic entry requires demonstrating bioequivalence and meeting device or injection system requirements).

What is the Orange Book status of SIGNIFOR LAR KIT (pasireotide long-acting injection)?

Featured snippet answer: Orange Book status determines the number and type of listed US patents (drug product, formulation, and method-of-use) and whether those patents are eligible for Paragraph IV. It also indicates “listed” versus “unlisted” protection, which controls the ability to trigger Hatch-Waxman litigation.

A complete Orange Book status table cannot be produced because the prompt does not provide:

• NDA number for SIGNIFOR LAR KIT
• Listed patent numbers
• Expiration and regulatory exclusivity dates tied to the NDA

How does SIGNIFOR LAR KIT compare with other pasireotide products on patent and market risk?

Featured snippet answer: In pasireotide portfolios, market risk often shifts between immediate-release/alternate formats and long-acting depot products. Long-acting injectables typically carry stronger formulation/process IP barriers but also higher generic development complexity.

What differentiates long-acting depot risk from other dosage forms?

• Higher manufacturing complexity and stability constraints
• Potentially more distinct formulation signatures that can be protected via formulation/process patents
• Bioequivalence requirements tied to depot release profiles, not just plasma exposure

Are there biosimilar risks for SIGNIFOR LAR KIT like a biologic?

Featured snippet answer: Biosimilar risk is not the primary analogue risk for SIGNIFOR LAR because pasireotide is not a biologic product in the FDA biosimilar framework. The competitive risk profile aligns to generics and, in some cases, “follow-on” long-acting injectables rather than biosimilars.

What competitive pathway replaces a biosimilar scenario?

• Generic drug approval pathway (ANDA) for a small-molecule drug product or a follow-on long-acting injectable product consistent with FDA’s generic framework
• Potential device/kit-level engineering for the injection system and reconstitution steps

What patent litigation affects SIGNIFOR LAR KIT and what settlement agreements matter?

Featured snippet answer: Litigation risk is measured by (a) whether a Paragraph IV case has been filed, (b) whether Novartis (or the listed NDA holder) has obtained preliminary injunctions (rare for long-acting injectables unless very specific claims are at issue), and (c) outcomes that invalidate or narrow claims.

A litigation-and-settlement timeline cannot be produced from the prompt because it does not include:

• Court cases, docket numbers, or parties
• Filed paragraph IV certifications
• Settlement agreement terms (dates and claims)

What formulations are protected by SIGNIFOR LAR KIT patents?

Featured snippet answer: Patent protection for long-acting injectable depots typically targets: depot-forming polymers, drug loading and dispersion, release-rate controlling architecture, particle size or microstructure, and manufacturing conditions that ensure reproducible release.

Which formulation attributes usually map to claim scope?

• Composition of the sustained-release matrix
• Pasireotide stability within the depot over storage time
• In-process controls for particle size distribution and homogeneity
• Release kinetics over the intended dosing interval

No claim-level formulation detail can be provided without the underlying patent documents.

What manufacturing/IP barriers exist for generic manufacture of SIGNIFOR LAR KIT?

Featured snippet answer: The barrier is practical know-how plus formulation/process patent scope. Even with a noninfringing formulation design, a generic long-acting injectable must match release characteristics and achieve bioequivalence.

Typical barriers investors underwrite

• Reproducible long-acting release profile across batches
• Sterile manufacturing and kit component compatibility
• Stability across shelf-life and shipping conditions
• Comparable injection mechanics and patient handling

Investment scenario: what do fundamentals say about downside from patent expiry and upside from sustained demand?

Investment scenario framework (IP-driven):

• Base case cash flow resilience is highest when the last enforceable patents cover depot formulation and manufacturing controls that are hard to design around.
• Downside accelerates if remaining patents are narrow method-of-use claims that can be avoided via label design or if formulation/process protection is close to expiry.
• Upside appears when the estate includes multiple claim families with staggered expiries, creating a “patent thicket” that delays generic entry.

Investment scenario framework (commercial-driven):

• SIGNIFOR LAR is used in endocrine indications where clinical inertia can support continued prescribing, but market share erosion can occur quickly once a competitor product launches with adequate bioequivalence and comparable administration.
• Long-acting injectable adoption can be durable, but payer formularies and acquisition of preferred injectables can shift faster than prescriber switching.

Because the prompt provides no commercial metrics (revenue, market share, prescribing trends, or guidance), no quantified revenue exposure or probability-weighted scenario table can be created.

Key Takeaways

• SIGNIFOR LAR KIT’s investment risk is governed by long-acting depot formulation/process IP and any remaining method-of-use protections tied to labeled indications.
• Biosimilar-style risk is not the primary concern; generic long-acting injectable entry is the more relevant competitive pathway.
• Orange Book status, remaining US patent expiries, and any Paragraph IV litigation are the gating items for launch timing and probability-weighted downside.
• Without NDA-linked Orange Book listings and patent/litigation identifiers, a quantified patent-expiry and generic-entry timeline cannot be stated accurately.

FAQs

1. What NDA does SIGNIFOR LAR KIT map to for Orange Book patent listings?
2. Which Orange Book listed patents are typically eligible for Paragraph IV for long-acting injectable products like pasireotide?
3. How do formulation and manufacturing patents affect the feasibility and timing of generic long-acting injectables?
4. What court outcomes most directly shorten exclusivity for depot products in Hatch-Waxman litigation?
5. How should investors model competitive entry once the last method-of-use patent expires but formulation patents remain?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).