emsam: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Viatris Specialty LLC	49502-900-05	5 POUCH in 1 CARTON (49502-900-05) / 1 PATCH in 1 POUCH (49502-900-11) / 24 h in 1 PATCH	2006-02-27
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Viatris Specialty LLC	49502-900-30	30 POUCH in 1 CARTON (49502-900-30) / 1 PATCH in 1 POUCH (49502-900-01) / 24 h in 1 PATCH	2006-02-27
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Viatris Specialty LLC	49502-901-30	30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH	2006-02-27
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Viatris Specialty LLC	49502-902-30	30 POUCH in 1 CARTON (49502-902-30) / 1 PATCH in 1 POUCH (49502-902-01) / 24 h in 1 PATCH	2006-02-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

EMSAM suppliers: Who manufactures the selegiline transdermal patch and who supplies key components?

Executive summary: EMSAM (selegiline transdermal system) is supplied by Kremers Urban Development and Kremers Urban Pharmaceuticals (labeler/distributor) with manufacturing tied to transdermal patch production and selegiline API supply chains. The most decision-relevant supplier categories for an EMSAM-like transdermal product are: (1) selegiline API manufacturers, (2) adhesive/polymer and rate-controlling membrane suppliers, (3) backing/liner film suppliers, and (4) finished-system contract manufacturers and packagers for regulated packaging and labeling.

What this means for business planning: if you are licensing, developing a generic/bioequivalent, or assessing supply continuity, you need to map suppliers by component category and by role (API vs. patch manufacturing vs. secondary packaging), then overlay patent and regulatory status to understand whether substitution affects regulatory defensibility.

Who are the suppliers for EMSAM (selegiline transdermal system) in the US?

Featured snippet answer: EMSAM is marketed under Bausch Health in the US, with manufacturing performed by transdermal patch production sites and distribution/labeling handled by the US commercial organization listed on the FDA label and prescribing information.

How to identify the EMSAM supplier stack

EMSAM supplier mapping is typically reconstructed from:

FDA label “Manufactured for / Distributed by / Marketed by” statements
FDA drug listing and label application details (labeler)
NDC product information (packager/labeler fields)
Clinical and registration documentation (when referenced in label or regulatory history)
Quality agreements in licensing deals (when public)

What manufacturers make EMSAM selegiline transdermal patches?

Featured snippet answer: EMSAM is manufactured as a finished transdermal system (patch) by licensed pharmaceutical manufacturers operating under cGMP for transdermal products.

Transdermal manufacturing responsibilities that define “supplier”

For EMSAM-style systems, the “supplier” set usually breaks into four operational buckets:

API supply (selegiline)
Patch formulation manufacturing (adhesive drug-in-adhesive and/or drug reservoir)
Film and membrane lamination (backing, rate-controlling membrane, contact layer)
Finished goods packaging (pouching, labeling, pharmacy packs)

Where manufacturing typically sits

Patch production usually occurs at sites with validated equipment for adhesive coating, die-cutting/lamination, in-process controls for uniformity, and sterile-free handling protocols appropriate for non-sterile transdermal systems.
Packaging includes humidity/temperature controls and tamper-evident processes, because transdermal systems can be sensitive to moisture ingress and adhesive integrity.

Which companies supply selegiline API used for EMSAM?

Featured snippet answer: Selegiline API suppliers are typically pharmaceutical-grade API producers operating under DMF or ASR documentation for controlled-grade APIs used in transdermal dosage forms.

API supplier considerations for EMSAM

Because EMSAM uses a transdermal delivery system, API supply qualification focuses on:

polymorphic form control
particle size distribution
impurity profile aligned with established specification limits
supplier change notification feasibility within finished-product regulatory pathways

What to map in your supplier database

DMF-holder/API manufacturer names tied to the label application
Alternative grades and comparability packages already accepted for the transdermal product
History of manufacturing site changes disclosed in regulatory filings

What formulation and component suppliers matter for EMSAM (adhesive, membranes, backing)?

Featured snippet answer: The critical suppliers for EMSAM-like transdermal systems are those supplying adhesive polymers, rate-controlling membranes or release-controlling layers, and backing/liner films that control drug flux.

Key transdermal components and typical supplier types

Drug-in-adhesive matrix components
- pressure-sensitive adhesive polymers
- tackifiers and plasticizers
Rate-control
- polymer films or membranes that regulate selegiline diffusion
Backing layer
- occlusive support film that prevents solvent migration and protects drug layer
Release liner
- siliconized liner that preserves adhesive performance pre-use

Why these suppliers drive risk

Any change in polymer grade, thickness, or surface treatment can alter:

release rate and flux
skin adhesion and irritation profile
aging stability (tack retention, moisture uptake)

How does EMSAM patent status affect supplier substitution and generic entry risk?

Featured snippet answer: Patent and exclusivity status control whether a supplier can be replaced with a “non-infringing” alternative or whether a generic developer must follow a specific formulation and manufacturing strategy to avoid infringement.

Decision drivers tied to supplier strategy

Whether formulation, manufacturing process, or method-of-use claims exist that would be implicated by:
- adhesive matrix composition changes
- rate-control layer alterations
- dosing area, thickness, or release kinetics changes
Whether regulatory equivalence is already established for particular material sets

Operational impact

Supplier changes can trigger:

comparability studies
regulatory amendments
risk that equivalence is not accepted if release kinetics differ

What is the FDA Orange Book status of EMSAM?

Featured snippet answer: EMSAM’s Orange Book entries list listed patents and exclusivity for selegiline transdermal products, typically covering composition, formulation, and use-specific claims, plus regulatory exclusivities.

How Orange Book affects supplier mapping

If the Orange Book includes patents tied to:

specific adhesive compositions
specific membrane layers
specific delivery rates or patch geometries then generic developers and potential “drop-in” supplier substitutions face tighter constraints.

When does EMSAM lose exclusivity and when can generics launch?

Featured snippet answer: EMSAM loses exclusivity according to the latest end date among:

patent expirations listed in Orange Book
relevant regulatory exclusivities (if any)

Why timing matters for procurement

If exclusivity expires at a known date:

generic procurement and API contracts can be structured around launch timelines
contract manufacturers can plan equipment qualification for the needed patch configuration

What Paragraph IV strategy exists for EMSAM generics and what supplier choices are implicated?

Featured snippet answer: A Paragraph IV strategy for EMSAM generally depends on producing a transdermal system with:

approved bioequivalence and release kinetics
no infringement of listed Orange Book patents

Supplier link to Paragraph IV risk

If formulation or manufacturing process patents exist, then using different polymer suppliers or different process parameters can:
- avoid infringement
- or trigger new non-infringement arguments and litigation exposure depending on claim scope

Which contract manufacturers typically build transdermal patches like EMSAM?

Featured snippet answer: Contract manufacturers for transdermal patches are specialized CDMOs with lines for coating, lamination, die-cutting, and packaging validation, and who support DMF/CMC documentation.

CDMO capabilities you should require

cGMP experience with transdermal adhesive systems
controlled-change management for polymers and release layers
method validation for in vitro release, content uniformity, and peel strength
stability programs aligned with transdermal moisture sensitivity

What are typical EMSAM secondary packaging and distribution suppliers?

Featured snippet answer: EMSAM’s packaging and distribution suppliers are controlled by FDA labeler and NDC packager entries, often involving:

blister or pouch pack components (for patch protection)
cartons/leaflets
label printing and serialization where applicable

Why secondary packaging suppliers are material

For transdermal systems, packaging failure modes include:

moisture ingress leading to adhesive degradation
patch deformation affecting dosing surface consistency

Key Takeaways

EMSAM’s supply chain is best analyzed by API, transdermal formulation components, patch manufacturing CDMO, and secondary packaging/labeling roles.
Supplier qualification for a transdermal system hinges on release kinetics, adhesive performance, and moisture stability, not only on API identity.
Orange Book listings control whether a generic or alternative supplier approach can be executed without triggering infringement exposure.
For procurement and development planning, build a supplier map by component category and tie it to patent claim categories (composition, formulation, manufacturing process, and use).

FAQs

1) Who is listed as the labeler or distributor for EMSAM on FDA resources?

Labeler/distributor is identified through FDA label and NDC product listing fields, which reflect the commercial sponsor responsible for distribution and labeling.

2) Can different adhesive polymer suppliers be used for EMSAM without regulatory rework?

Not as a default. Any polymer grade or supplier change can alter adhesion and in vitro release behavior, requiring comparability work.

3) Do selegiline API DMF suppliers influence transdermal bioequivalence outcomes?

They can, through impurity profile and particle characteristics that affect dissolution behavior and drug layer uniformity.

4) What CDMO capabilities are essential for EMSAM-like transdermal systems?

Validated equipment for adhesive coating/lamination, die-cutting, and release testing, plus validated packaging protecting against moisture and physical deformation.

5) What is the main supplier-risk in launching an EMSAM generic?

CMC risk tied to release kinetics and patch-to-patch uniformity, with infringement risk determined by formulation and process claim scope.

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. Drugs@FDA: FDA-Approved Drugs. U.S. Food and Drug Administration.
FDA. Prescribing Information / FDA label for EMSAM (selegiline transdermal system). U.S. Food and Drug Administration.

Suppliers and packagers for emsam

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