Viewing data from:

EMSAM

NDA

SELEGILINE | N021336 | SOMERSET PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

24 trials from ClinicalTrials.gov, 19 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Infusion Laboratory: Protocol 1 - Selegeline - 2 NCT00000337	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	—	1994-11
Selegiline for Smoking Cessation - 1 NCT00439413	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	246	2007-06 → 2009-01
Usefulness of Selegiline as an Aid to Quit Smoking - 1 NCT00129311	Phase 2	Completed	Yale University	101	2004-07 → 2012-12
Selegiline in Outpatient Treatment for Cocaine Dependence - 1 NCT00000336	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	1995-01 → 1996-03
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder NCT01912391	Phase 3	Completed	Mood and Anxiety Research, Inc	30	2012-10 → 2015-03
Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1 NCT00218517	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	19	2005-03 → 2007-07
Selegiline in Treatment of Cocaine Dependence - 2 NCT00000188	Phase 2	Completed	University of Pennsylvania	50	1994-09 → 1995-10
A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia NCT00002154	Phase 2	Completed	The Dana Foundation	32	—
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression NCT00531947	Phase 4	Completed	Somerset Pharmaceuticals	308	2007-07 → 2010-10
Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists NCT00443872	Phase 4	Completed	Parkinson's Disease and Movement Disorder Center of Boca Raton	77	2007-03 → 2008-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$75.41

per ea

Lowest NADAC/Unit

$74.92

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49502090230EMSAM 12 MG/24 HOURS PATCH	$75.41	EA	Brand	—	2026-06-17
49502090130EMSAM 9 MG/24 HOURS PATCH	$75.14	EA	Brand	—	2026-06-17
49502090030EMSAM 6 MG/24 HOURS PATCH	$74.92	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$1621.65

Highest Price

$1626.41

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49502-0902-30EMSAM 12MG/24HRS TRANSDERMAL SYSTEM	$1621.65	FSS	Mylan Specialty L.P.	01/14/2027
49502-0902-30EMSAM 12MG/24HRS TRANSDERMAL SYSTEM	$1621.65	Big4	Mylan Specialty L.P.	01/14/2027
49502-0900-30EMSAM 6MG/24HRS TRANSDERMAL SYSTEM	$1623.11	FSS	Mylan Specialty L.P.	01/14/2027
49502-0900-30EMSAM 6MG/24HRS TRANSDERMAL SYSTEM	$1623.11	Big4	Mylan Specialty L.P.	01/14/2027
49502-0901-30EMSAM 9MG/24HRS TRANSDERMAL SYSTEM	$1626.41	FSS	Mylan Specialty L.P.	01/14/2027
49502-0901-30EMSAM 9MG/24HRS TRANSDERMAL SYSTEM	$1626.41	Big4	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Emsam (2024)

Total Spending

$12.5M

Total Claims

5,355

Beneficiaries

866

Avg Cost/Unit

$71.43

Spending Trend

$11.0M(2019)→$11.8M(2020)→$12.4M(2021)→$11.9M(2022)→$12.4M(2023)→$12.5M(2024)

YoY Change:+0.4%

5yr CAGR:+4.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLSELEGILINE BASE

DMF 309572017

MATRIX PHARMACORP PRIVATE LTDSELEGILINE

DMF 387972023

APICORE LLCSELEGILINE

DMF 426422025

ARENOL CHEMICAL CORPInactiveSELEGILINE (DEPRENYL) HYDROCHLORIDE

DMF 100361992

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHInactiveSELEGILINE

DMF 123851997

APICORE LLCInactiveSELEGILINE

DMF 370462022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 17, 2017	SUPPL -14	View Letter (PDF)
Apr 1, 2015	SUPPL -11	View Letter (PDF)
Sep 16, 2014	SUPPL -5	View Letter (PDF)
Sep 16, 2014	SUPPL -10	View Letter (PDF)
Feb 14, 2008	SUPPL -1	View Letter (PDF)
Aug 2, 2007	SUPPL -2	View Letter (PDF)
Mar 3, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 6MG/24HR

RLD

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Feb 27, 2006

No patent or exclusivity listings for this strength.

#002 — 9MG/24HR

RLD

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Feb 27, 2006

#003 — 12MG/24HR

RLD

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Feb 27, 2006