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

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

International Patents for SIGNIFOR

See the table below for patents covering SIGNIFOR 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
Australia	714447
Brazil	9609335	ANÁLOGOS DE SOMATOSTATINA, BEM COMO COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO OS MESMOS.

Supplementary Protection Certificates for SIGNIFOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1686964	300716	Netherlands		PRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
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
1686964	92701	Luxembourg		PRODUCT NAME: PASIREOTIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE OU UN HYDRATE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/12/753 SIGNIFOR-PASIREOTIDE 20141121
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	2012/027	Ireland		PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424

SIGNIFOR (pasireotide): Investment Scenario and Patent-to-Revenue Fundamentals Analysis

Last updated: July 16, 2026

SIGNIFOR (pasireotide) revenue and investment outlook hinge on a single driver: whether investors underwrite sustained uptake of pasireotide in Cushing disease and acromegaly versus fast-follow competition and the patent-driven timeline for follow-on and generic entry. Market leverage concentrates in continued payer support, robust differentiation in efficacy and safety management, and execution on long-duration formulations and indications. IP risk is tied to the breadth and enforceability of composition, formulation, and method-of-use patents listed for SIGNIFOR, plus exclusivity expirations and any FDA-regulated product “exclusivity” classifications that block or slow generic/oral follow-on.

What is SIGNIFOR (pasireotide) and how does it perform commercially?

SIGNIFOR is an injectable somatostatin analog indicated for:

• Cushing’s disease (adults with Cushing’s disease for whom surgery is not an option or has not been curative).
• Acromegaly (adults with acromegaly who have had an inadequate response to or are not appropriate for treatment with somatostatin analogs).

Core investment premise: SIGNIFOR’s value is tied to sustained clinical positioning in high-unmet-need endocrine populations where other somatostatin analogs underperform, balanced against tolerability constraints that can drive access friction (notably hyperglycemia risk characteristic of pasireotide-class activity).

How much revenue exposure does SIGNIFOR have versus category spend?

The investment case depends on:

• persistence of Cushing’s disease demand (smaller population but higher unmet need),
• durability of acromegaly share in patients who fail first-line somatostatin analogs.

When the therapy is a niche but differentiated asset, investors typically underwrite a stable-to-gradual revenue curve rather than rapid growth, with upside from guideline adoption and payer negotiations that maintain formulary access.

What patents protect SIGNIFOR (pasireotide) and how strong is the estate?

A complete investment-grade view requires a jurisdiction-by-jurisdiction map of:

• Orange Book patent listings (US),
• PCT and national phase filings (EP, JP, CA),
• patent families on composition, formulation, and method-of-use,
• any listed “use” patents tied to Cushing’s disease and/or acromegaly.

Patent strength assessment framework investors use:

1. Number of active families covering:
   • drug substance and composition,
   • injectable formulation and release profile,
   • dosing regimen and patient selection,
   • method-of-use for Cushing disease and acromegaly.
2. Claim durability (how many claims survive typical obviousness/obvious-type challenges).
3. Expiration clustering (risk if multiple patents expire in a short window).
4. Litigation history (estoppel, claim construction outcomes, settlement scope).
5. Non-infringement and design-around space (especially relevant for injectable formulations).

Which companies own the SIGNIFOR patent estate in major jurisdictions?

Investors need the assignee and legal status across families because the licensing and enforcement strategy typically determines settlement leverage in Paragraph IV or non-infringement campaigns.

Without a specific Orange Book listing set and patent family table, no defensible claim of “how many patents” or “what expiration dates” can be produced.

What formulations are protected by SIGNIFOR patents?

For injectable products, the high-value patent clusters usually include:

• formulation composition (buffers, stabilizers, particle properties),
• lyophilized vs suspension state constraints,
• manufacturing steps defining critical parameters,
• device or delivery-system constraints if any are tied to claims.

A credible investment view must tie each formulation claim cluster to:

• the specific dosage form(s) on the US label,
• the version in commercial distribution (strengths, packaging).

When does SIGNIFOR lose exclusivity in the US and EU?

For investment timelines, investors track two layers:

• FDA exclusivity (drug exclusivity and/or any additional exclusivity programs, if applicable).
• Patent term and any patent-term adjustments (PTA) or pediatric exclusivity extensions.

What matters for investors:

• whether generic entry is blocked by unexpired patents at the application submission date for ANDA,
• whether the product is protected by multiple overlapping patents such that the first Paragraph IV does not clear the field.

What generic entry risks exist for SIGNIFOR?

The generic risk is strongest when:

• formulation and method-of-use patents are narrow or close to expiration,
• there is precedent of easy design-around for the formulation,
• litigation settlements (if any) permit early launch dates.

The generic risk is weaker when:

• method-of-use patents are broad and consistently asserted,
• formulation/manufacturing patents are numerous and enforceable,
• a settlement creates a delayed-entry or paid-up-front structure.

What is the Orange Book status of SIGNIFOR and which patents are listed?

An Orange Book status section must enumerate:

• each listed patent number,
• patent type (composition, method, formulation),
• expiration date,
• listed exclusivity codes.

A complete Orange Book section cannot be generated without the exact listing set and patent numbers currently reflected in the Orange Book.

How do Orange Book “use” patents affect ANDA and Paragraph IV strategy?

Method-of-use patents can deter generic entry even if composition patents expire, depending on:

• what claims cover (Cushing selection, acromegaly after failure of somatostatin analogs),
• whether the generic’s proposed labeling would infringe.

Investors typically model:

• probability-weighted launch delays,
• likelihood of settlement or injunction risk.

What patent litigation affects SIGNIFOR and how does it shape the investment scenario?

Patent litigation impacts investment scenarios through:

• injunction risk that can stop launch,
• settlement terms that can create fixed “at-risk-to-allowed” launch dates,
• claim construction that can narrow or broaden protection.

What Paragraph IV challenges exist for SIGNIFOR?

A credible investment scenario requires:

• filing dates,
• paragraph certifications (IV vs I/II/III),
• asserted patents,
• litigation outcomes and any appellate activity.

Without the current litigation docket data, no accurate entry-path analysis can be produced.

How does SIGNIFOR compare with competitors in Cushing disease and acromegaly?

Investment positioning is driven by:

• efficacy and safety profiles versus other endocrine agents,
• payer preference trends,
• administration burden and patient adherence.

Key comparators include other somatostatin analogs and subsequent-line options used when first-line somatostatin analogs fail.

Does pasireotide (SIGNIFOR) face stronger biosimilar competition in any segment?

SIGNIFOR is a small-molecule injectable peptide analog, so “biosimilar competition” is not the direct analog of antibody biologic pathways. The relevant “follow-on” risk is generic and formulation competition, not biosimilar substitution.

What FDA regulatory status and labeling elements impact SIGNIFOR’s commercial durability?

Investment-grade regulatory review focuses on:

• the current indication scope on the label,
• any recent label updates that add or remove patient populations,
• risk-management actions and REMS requirements (if any),
• postmarketing safety that affects utilization.

What safety constraints influence payer uptake and persistence?

Pasireotide-class products are constrained by metabolic effects. Investors track:

• required monitoring,
• clinician willingness to continue therapy,
• payer prior authorization intensity.

The commercial durability of SIGNIFOR depends on whether safety monitoring protocols are integrated into real-world care pathways.

What are the commercial fundamentals behind an investment case for SIGNIFOR?

Investors usually model an asset like SIGNIFOR using four quantitative pillars:

1. Market size and addressable population in Cushing’s disease and in acromegaly post-somatostatin analog failure.
2. Share of diagnosis-driven demand (rate of initiating therapy after prior-line failure).
3. Net price and access stability (rebates, formulary placement, prior auth).
4. Loss-of-exclusivity timing and probability of delayed launch via litigation.

Without a specific dataset of current revenues, gross-to-net, payer coverage rates, and explicit patent expiration dates, any numeric underwriting would be speculative.

What licensing and deal structures exist for SIGNIFOR that matter to investors?

Investment outcomes improve when:

• co-promotion or territory licensing preserves margin,
• milestone payments align with indication expansion,
• settlements reduce near-term launch risk.

A deal-structure analysis requires:

• names of licensing counterparties,
• agreement dates,
• territory scope,
• royalty rates and termination provisions.

A defensible deal analysis cannot be produced without the underlying contract terms and public disclosures.

Which investment scenarios dominate for SIGNIFOR over the next 1–5 years?

Base case

• SIGNIFOR maintains mid-single digit to low-single digit revenue trends driven by persistence in Cushing disease and selected acromegaly patients.
• Net sales are pressured by price renegotiations but stabilized by payer control and differentiated benefit in second-line settings.
• Patent protection remains a meaningful barrier to generic substitution.

Upside case

• Indication or guideline reinforcement increases initiation rates.
• Improved real-world safety management reduces discontinuations.
• Longer effective exclusivity blocks early generic entry.

Downside case

• Accelerated erosion from follow-on products or earlier-than-expected patent cliffs.
• Greater payer restrictions tied to safety monitoring cost.
• Litigation defeats that shorten the time to market for at-risk entry.

Key Takeaways

• SIGNIFOR’s investment fundamentals are driven by differentiated efficacy positioning in Cushing’s disease and post-somatostatin-analog acromegaly, tempered by safety and payer access constraints.
• The dominant risk variable is IP timing: patent breadth across composition, formulation, and method-of-use plus Orange Book-controlled barriers to ANDA entry.
• A credible underwriting requires a precise Orange Book table (patent numbers, types, expirations) and litigation status to model launch probabilities.

FAQs

1. How do Orange Book “method-of-use” patents for pasireotide block ANDA label changes?
2. What are the usual claim types that decide whether a generic injectable can design around pasireotide formulation patents?
3. What real-world endpoints most predict SIGNIFOR persistence in Cushing’s disease and acromegaly?
4. How does a safety monitoring burden (hyperglycemia) translate into payer restrictions and net price pressure?
5. What settlement terms typically determine whether a generic launches “at risk” or after an agreed entry date for niche injectables?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drug Trials Snapshots. FDA. https://www.fda.gov/drugs/drug-trials-snapshots