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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Emsam (2023)

Total Spending

$12.4M

Total Claims

5,360

Beneficiaries

877

Avg Cost/Unit

$71.12

Spending Trend

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

YoY Change:+8.5%

5yr CAGR:+6.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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