Suppliers and packagers for generic pharmaceutical drug: LANREOTIDE ACETATE

LANREOTIDE ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-906-67	1 POUCH in 1 CARTON (69097-906-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE	2025-05-30
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-907-67	1 POUCH in 1 CARTON (69097-907-67) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE	2025-05-30
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-908-67	1 POUCH in 1 CARTON (69097-908-67) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE	2025-05-30
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	EXELAN PHARMACEUTICALS, INC.	76282-718-67	1 POUCH in 1 CARTON (76282-718-67) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE	2025-05-30

Last updated: May 26, 2026

ecutive summary Lanreotide acetate is a prescription somatostatin analog supplied today through limited manufacturer channels tied to the original brand and any licensed follow-on products. The practical supplier set depends on the commercial product form (notably autogel vs. deep subcutaneous depot) and the geography’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) listings and FDA-approved labeling. Without a specified brand name (and dosage form) in the prompt, a complete, product- and jurisdiction-specific supplier map cannot be produced from verifiable patent/regulatory records.

Which companies supply lanreotide acetate (active ingredient) and finished drug products?

Featured answer Lanreotide acetate supply is typically concentrated among the original developer and manufacturers with FDA-approved Abbreviated New Drug Application (ANDA) or “authorized generic” channels only after regulatory and patent-driven entry windows open for specific strengths and delivery systems.

Who are the typical supply nodes in the lanreotide acetate value chain?

1. Finished dosage form manufacturers (drug product sites) that produce sterile depot formulations and package for distribution.
2. Active pharmaceutical ingredient (API) manufacturers that supply bulk lanreotide acetate to sterile depot partners.
3. Contract manufacturers / fill-finish networks that handle prefilled syringes or depot device filling, depending on the product presentation.

What product attributes determine the supplier?

Lanreotide is delivered as a long-acting depot. Supplier identity changes based on:

• Dosage form/device (e.g., deep subcutaneous depot vs. autogel-type presentation).
• Strength (e.g., 60 mg, 90 mg, and related strengths, depending on the marketed line).
• Regulatory approval version and manufacturing site (often tightly controlled for injectables).

What patents protect lanreotide acetate supply and can block generic API or depot manufacturing?

A supplier list must be filtered through patent and regulatory exclusivity status, because generic manufacturers face timing and manufacturing-use constraints that map to:

• Composition-of-matter (drug substance and salts).
• Formulation patents (depot composition and particle characteristics).
• Manufacturing process patents (sterile depot manufacture and release criteria).
• Method-of-use (approved indications and dosing regimens where relevant).

Common patent estate categories you must screen for lanreotide depots

• Drug substance claims tied to lanreotide acetate itself and related stereochemical or salt forms.
• Depot formulation claims tied to the carrier, viscosity, and microenvironment designed for extended release.
• Device and administration claims where prefilled formats or injection mechanics are claimed.

How does this affect supplier eligibility?

• API suppliers can enter only if they can support a downstream finished dosage form that is not blocked for the specific strength/presentation.
• Depot manufacturers need freedom to manufacture, test, and package in a manner consistent with the regulatory pathway and patent landscape.

What is the Orange Book status of lanreotide acetate products and which entries indicate current manufacturers?

The Orange Book is the primary system that links specific strengths and dosage forms to:

• Active ingredient and applicant/holder
• Orange Book patent numbers
• Regulatory exclusivity codes
• Submission type (505(b)(1) vs. ANDA vs. 505(j))

Featured answer Orange Book listings for lanreotide depots identify the product sponsors and the patent sets that govern entry risk for generic suppliers.

How to interpret supplier signals from Orange Book listings

• Look for ANDA applicants (finished product suppliers) for each strength/presentation.
• Identify reference listed drug (RLD) for each product line.
• Cross-link submission/holder to:
  • Drug product manufacturer sites
  • Labeler and distributor chain
  • Patent expiration and exclusivity windows

When does generic lanreotide acetate face entry risk for each dosage form?

Entry timing depends on the intersection of:

• Patent expirations for drug substance, formulation, and method-of-use patents
• Regulatory exclusivities (such as new chemical entity or other exclusivity periods where applicable)
• Litigation settlements that can trigger automatic market-entry limits

What drives launch sequencing for generics?

• If a competitor files a Paragraph IV certification, launch is gated by:
  • 27-month stay where triggered
  • Court decisions or consent judgments
  • Settlement agreements

What delivery-system constraints matter most?

For depot products, even when composition patents fall, the depot manufacturing method, particle properties, and sterile release specs can remain protected by secondary patents or trade dress-like constraints tied to regulatory filings.

Which patent litigation affects lanreotide acetate suppliers and generic entry?

Patent litigation typically targets:

• Depot formulation similarity and release kinetics
• Process claims for manufacturing and sterilization
• Method-of-use claims where dosing is tied to specific clinical regimens

What litigation outcomes change supplier markets fastest?

• Consent judgments that narrow which generic strengths can launch.
• Settlements that delay launch for the dominant contested product line.
• Court rulings that invalidate or narrow formulation claims for specific depot compositions.

What formulations are protected for lanreotide acetate and how does that affect who can manufacture?

Depot products depend on:

• Extended release polymer matrix or carrier system
• Particle size distribution
• Viscosity control and syringeability parameters
• Stability and re-suspension criteria

Formulation IP screening targets

• Extended-release carrier systems
• Sterile depot suspension composition
• Drug loading and release-rate control
• Stability at labeled storage conditions

Why formulation IP blocks “API-only” suppliers

Even if an API is unencumbered, depot formulation patents and regulatory sameness requirements determine whether a finished generic can be substituted in practice.

Commercial risk: what supplier constraints exist for lanreotide acetate?

Injectables with depot technology face:

• Specialized sterile manufacturing capacity
• Tight regulatory controls on particle and release profiles
• Long lead times for depot device components
• Constrained distribution due to cold chain or handling requirements (product-label dependent)

What this means for downstream buyers

Procurement risk concentrates in:

• A small number of finished-dose suppliers per strength/presentation
• Limited surge manufacturing capacity if shortages occur

Comparison: how do lanreotide acetate supplier dynamics differ from other somatostatin analogs?

Supplier concentration patterns are common across long-acting somatostatin analog depots:

• Patent estates often cover depot formulation and release mechanics.
• Generic availability is typically slower than for non-depot small molecules.
• Device and sterile manufacturing add operational barriers.

Practical supplier selection criteria

• Approved strength/presentation matches
• Orange Book patent and exclusivity status clearance
• Availability of regulatory documentation for interchangeability/substitution in the target market

---

Key Takeaways

• Lanreotide acetate supply is constrained by product-specific depot formulation and regulatory/patent barriers that vary by strength and presentation.
• A credible supplier list requires tying lanreotide acetate to the exact FDA-approved product line (brand, strength, dosage form) and then reading current Orange Book submissions and patent status for those listings.
• Generic and follow-on supply depends on cleared patent and exclusivity timing, plus any litigation-driven launch limits.

FAQs

1. Which companies hold the FDA-approved lanreotide depot listings by strength and dosage form?
2. What Orange Book patents are listed for lanreotide acetate depot products and what are their expiration dates?
3. Do Paragraph IV challenges exist for lanreotide depot strengths, and what launch dates follow litigation or settlements?
4. Which manufacturing-site constraints typically limit supplier switching for long-acting injectable depots like lanreotide acetate?
5. How does the supplier landscape for lanreotide depots compare with octreotide long-acting formulations in terms of generic availability?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drug Approval and Databases: Orange Book, labeling, and application information. (Accessed via FDA).