August 2026 - Somatostatin Receptor Agonists drug patent information, international generic entry, market access

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	7,473,761	⤷ Start Trial	Y	Y		⤷ Start Trial
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	7,473,761	⤷ Start Trial	Y	Y		⤷ Start Trial
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	7,473,761	⤷ Start Trial	Y	Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 26, 2026

Somatostatin receptor agonists are a mature but still IP-sensitive class driven by oncology and neuroendocrine tumor (NET) uptake, with revenue concentration in branded depot and radioligand-adjacent products. Patent leverage is largely split between (1) peptide/prodrug composition-of-matter, (2) formulation and depot manufacturing, and (3) method-of-use indications. As key patents approach expiration across major members, market dynamics shift toward biosimilar-like supply positioning for peptide depots (via non-bioequivalent competitors), “follow-on” generics for tablets/capsules where applicable, and formulation-specific carve-outs that can sustain exclusivity longer than the active ingredient term.

The competitive field clusters around several somatostatin receptor (SSTR) targeting technologies, most prominently SSTR2-directed agents used in NETs. The patent estate and exclusivity calendar are product-specific, with the highest watch items typically in long-acting depot manufacturing claims, indication-specific method patents, and later-cycle formulation patents designed to extend exclusivity.

What patents protect somatostatin receptor agonists (SSTR2 SSTR5) and how many are there by product?

Featured snippet answer: Patent protection for somatostatin receptor agonists is typically concentrated in composition-of-matter for the peptide, formulation/depot manufacturing process claims, and method-of-use claims tied to NETs and hormone-related indications. The actionable count depends on product family scope and whether later patents added formulations or expanded indications.

Patent families that dominate enforcement and licensing

Composition of matter (C/O/M) for the peptide (and sometimes stereochemistry, salts, analogs, or prodrugs).
Formulation and depot technology for long-acting injectables (polymer matrix, particle size, release kinetics, lyophilization or reconstitution methods, stabilizers).
Manufacturing methods (stepwise synthesis, purification, filtration, sterilization, aseptic fill, and depot formation).
Method-of-use (tumor response endpoints, radiographic response, symptom control, specific receptor expression stratification, lines of therapy).
Device or kit claims where administration depends on special delivery systems (less common for peptides than formulation/process claims).

Where patent density tends to be highest

Patent “thickness” typically increases for:

Long-acting depot injectables due to multiple ways to vary polymer, concentration, particle size distribution, and release rate.
On-label tumor indication expansions that generate new method-of-use filing cycles.
Combination regimens (SSTR agonist plus chemotherapy, targeted therapy, or radiotherapy) where endpoints and dosing schedules are claimed.

Typical assignee patterns

The SSTR agonist space is dominated by originators and their formulation partners, with late-cycle patents also filed by assignees tied to manufacturing scale-up and process development.

When do major somatostatin receptor agonists lose exclusivity and what drives the timing?

Featured snippet answer: Exclusivity loss is driven by the later of primary composition patent expiry, regulatory exclusivity (where applicable), and any granted pediatric exclusivity, plus the presence of formulation or method-of-use patents that extend practical market exclusivity even after the active substance patent expires.

Exclusivity timeline drivers (practical market view)

Primary patent expiration for the core peptide.
OTC/line-of-therapy exclusivity gaps caused by method-of-use claims that remain enforceable even if a generic can be produced.
Depot manufacturing patent barriers that can block generic approval pathways through “non-infringing” process workarounds.
Orange Book-listed listed patents that keep FDA approvals on hold unless carve-outs are possible.

Key observation for investors and licensors

Even where the active ingredient’s earliest patent expires, remaining depot formulation and method patents frequently become the gating factor for first-to-market entrants.

What is the Orange Book status of somatostatin receptor agonists (listed patents, expiration, and remaining exclusivities)?

Featured snippet answer: Orange Book status is product-specific and is typically characterized by multiple listed patents covering the NDA drug substance and drug product, plus one or more method-of-use patents. The Orange Book listings often remain the best map for “what must be addressed” under ANDA Paragraph IV.

How to interpret Orange Book listings for this class

Drug substance vs. drug product: For peptide agonists, enforceability often tracks drug substance and drug product patents until depot formulation claims expire.
Method-of-use patents: For NETs, method claims can keep carve-out strategy difficult if an ANDA attempts the same indication.
Multiple listed patents per NDA: Each listed patent can trigger separate Paragraph IV strategy decisions and settlement leverage.

Practical Orange Book “gating” patterns

If a generic can avoid the drug product patents but cannot avoid method-of-use claims, launch may be delayed pending a strategy such as label carve-out, licensing, or design-around.

How strong is the patent estate for somatostatin receptor agonists in depot formulations?

Featured snippet answer: Strength is usually highest in depot formulation and manufacturing claims because small changes to polymer composition, concentration, and process parameters can still fall within claim scope. The estate also benefits from multiple late-cycle filings that refine process and release characteristics.

Common claim targets in depot patents

Polymer matrix composition (type, grade, molecular weight distribution).
Drug loading, viscosity ranges, and mixing conditions.
Particle size distribution and suspension stability.
Release profile parameters (in vitro release curves tied to in vivo performance).
Manufacturing steps that define critical quality attributes.

Design-around risks

Generic entrants often need to show:

Non-infringing depot formulation and/or process.
Equivalent release kinetics within allowed ranges.
No overlap with explicitly claimed polymer systems or process windows.

Licensing leverage profile

Originators tend to settle when:

Generic entrants face expensive redesign cycles.
Settlement allows label launch at a delayed date with non-infringement or license scope that clears the most relevant listed patents.

Which companies are challenging somatostatin receptor agonists with Paragraph IV ANDAs, and how do settlements typically work?

Featured snippet answer: Patent challenges follow a recurring pattern: first-wave ANDAs target the largest-volume NET products, then follow-on entrants attempt carve-outs. Settlements often set a “design-around launch date” or a delayed entry tied to specific patent expiry, sometimes with stipulated nonmarketing or stipulated injunction covenants.

What filings tend to look like in this class

Paragraph IV notices referencing Orange Book-listed patents, often focusing on one or two key patents rather than every listed patent at once.
Litigation that centers on depot formulation and method-of-use claims, with generic counterarguments about invalidity and non-infringement.

Settlement mechanics that matter for market entry

Delayed launch windows tied to the later-expiring formulation or method patents.
Label restrictions (carve-outs) that avoid infringement for specific indications.
Work-sharing on manufacturing where generic agrees to a noninfringing process that may reduce product performance risk.

What patent litigation affects somatostatin receptor agonists and what outcomes matter commercially?

Featured snippet answer: Litigation commonly impacts timing more than product availability because courts and settlement agreements determine whether generics can launch on-label or only off-label, and whether launch is blocked entirely pending appeals or stays.

Litigation “hot zones” for SSTR agonists

Depot formulation patent disputes: claim construction around polymer and release profile language.
Method-of-use claims: whether the proposed label or dosing regimen infringes even if the product itself is the same.
Injunction outcomes: whether an injunction stays approval or stays marketing.

Commercial impact paths

If injunction issues against marketing, the generic loses its planned market timing and may pivot to other indications.
If a generic wins on one patent but loses on another, an early launch still may be blocked.

How does the patent landscape for somatostatin receptor agonists compare across products (short-acting vs long-acting vs radioligand-adjacent)?

Featured snippet answer: Long-acting depot formulations typically have broader and thicker formulation and process patent estates than short-acting peptides. Radioligand-adjacent technologies can have additional IP layers around targeting moieties and combination regimens, which can change the exclusivity profile.

Short-acting peptide agonists

Often have fewer depot formulation claims but can have strong composition and manufacturing patents.

Long-acting depot agonists

Higher density in formulation/process and release profile.

Radioligand-adjacent or receptor-targeted combinations

Patent scope can extend into dosing schedules, combination endpoints, and sometimes kit-like administration parameters.

What generic entry risks exist for somatostatin receptor agonists by dosage form?

Featured snippet answer: Generic entry risk is highest for long-acting injectables due to formulation/process claim density and label-level method patents. For oral or short-acting forms, entry risk is more tied to composition-of-matter and method-of-use.

Dosage form risk map

Long-acting injectable depot: high risk (formulation/process + method-of-use).
Oral SSTR agonist forms (where applicable): moderate risk (C/O/M + method-of-use).
Reconstitution or kit dependencies: moderate to high risk if manufacturing/kit steps are claimed.

Product-specific “entry blockers” that recur

Polymer or particle size specification overlap.
Release profile parameters that are difficult to match without using a covered formulation.
Method-of-use label alignment that triggers infringement.

What formulations are protected for somatostatin receptor agonists (polymer matrix, microencapsulation, salts, prodrugs)?

Featured snippet answer: The formulation IP generally protects polymer matrix depot systems, microstructure and particle size attributes, stabilizer and salt forms, and release-profile-defined depot designs. Salt/prodrug variations can add additional patent layers in specific markets.

Formulation subcategories

Depot polymer systems (composition and manufacturing conditions).
Particle structure (size distribution, suspension stability, reconstitution).
Salt forms and polymorphs (where claimed).
Stabilizers and excipients (limited to ranges that are explicitly claimed).
Reconstitution kits (if the product requires a defined delivery workflow).

Do method-of-use patents for somatostatin receptor agonists block generic launches?

Featured snippet answer: Yes, method-of-use patents can delay launches even when a generic can design around drug product patents. If the generic seeks the same labeled indication or performs patented dosing regimens, generic entry can be blocked or require label carve-outs.

How method patents interact with ANDA approval

A generic may be approved but face marketing restrictions if method patents are not cleared.
If method patents are Orange Book-listed, the generic must address them through Paragraph IV, carve-out, or license.

Typical method claim coverage

Treatment of NETs and related symptom control.
Tumor response in receptor-positive populations.
Sequencing with other oncology therapies.

How do biosimilar concepts apply to somatostatin receptor agonists?

Featured snippet answer: Most somatostatin receptor agonists are small peptides with chemical identity that follow traditional generic frameworks rather than biosimilar pathways. Practical “biosimilar-like” risk arises when manufacturing variability affects depot release characteristics, not from biosimilarity legal standards.

What changes the risk profile for peptide agonists

Depot manufacturing and release profile equivalence can matter as much as sequence identity.
Claim scope around excipients, particle distribution, and process windows can effectively function like “biologic comparability” barriers.

Key market dynamics for somatostatin receptor agonists: pricing pressure, contracting, and supply

Featured snippet answer: Market dynamics are shaped by (1) NET incidence and regimen uptake, (2) payer contracting that prefers depot convenience and demonstrated response, (3) supply reliability for long-acting injectables, and (4) patent expiry-driven competitive entries that compress net pricing.

Revenue concentration and payer leverage

Depot products often capture large share in NETs due to adherence advantages and clinician familiarity.
Payers push for discounts and formulary placement, especially as exclusivity nears expiration.

Supply and manufacturing scale-up risk

Generic entrants face risk in depot manufacturing yield, release profile consistency, and regulatory chemistry controls.
Any manufacturing deviation increases risk of rejection or delay, pushing launch calendars.

Key takeaways

Patent protection for somatostatin receptor agonists typically concentrates in composition, depot formulation/process, and method-of-use claims tied to NET and oncology indications.
Exclusivity timelines are often extended in practice by later-cycle formulation and method patents, not just by the earliest active ingredient expiry.
Orange Book-listed patents generally define the “what must be cleared” map for ANDA Paragraph IV strategies and settlement leverage.
Long-acting injectables face the highest generic entry risk due to formulation/process claim density and label-level method-of-use constraints.
Market competition typically intensifies around the combination of regulatory readiness and clearing the latest listed patents, with pricing pressure arriving quickly after launch.

FAQs

1) What are the most common patent claim types that block generic somatostatin receptor agonists?
Formulation/depot manufacturing claims and Orange Book-listed method-of-use claims are the dominant blockers.

2) Can a generic somatostatin receptor agonist launch with an indication carve-out?
Often only if the carve-out avoids Orange Book method-of-use patents tied to the remaining labeled indication.

3) What patent expiry order usually matters most for NET somatostatin receptor agonists?
The latest-expiring Orange Book-listed depot formulation and method patents usually govern the practical launch window.

4) How do settlements typically structure launch timing for challenged somatostatin receptor agonists?
They usually set delayed market entry tied to specific patent expirations and may impose label restrictions or nonmarketing terms.

5) Does “generic equivalence” depend more on composition or depot release performance for somatostatin receptor agonists?
For depot products, release performance and manufacturing/process equivalence strongly affect regulatory and infringement risk.

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. ANDA Product-Specific Guidance and Paragraph IV Notice Provisions. U.S. Food and Drug Administration.
United States Patent and Trademark Office (USPTO). Patent Basics and Claims. USPTO.
FDA. Drug Approval Process (NDA and ANDA Overview). U.S. Food and Drug Administration.