Viewing data from:

ZELAPAR

NDA

SELEGILINE HYDROCHLORIDE | N021479 | BAUSCH HEALTH US LLC

1 strength0 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 Zelapar (2023)

Total Spending

$626K

Total Claims

110

Beneficiaries

Avg Cost/Unit

$92.95

Spending Trend

$2.1M(2019)→$1.9M(2020)→$1.3M(2021)→$894K(2022)→$626K(2023)

YoY Change:+8.5%

5yr CAGR:+7.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs8 inactive

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

EUROAPI HUNGARY LTDSELEGILINE HYDROCHLORIDE

DMF 51611983

DIPHARMA FRANCIS SRLSELEGILINE HYDROCHLORIDE

DMF 92751991

CATALENT UK SWINDON ZYDIS LTDSELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG

DMF 159142002

WYCKOFF CHEMICAL CO INCInactiveSELEGILINE HYDROCHLORIDE

DMF 92301991

ALCHYMARS SPAInactiveSELEGILINE HYDROCHLORIDE

DMF 97341992

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 102351993

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHInactiveSELEGILINE HYDROCHLORIDE

DMF 103401993

IROTEC LABORATORIESInactiveSELEGILINE HYDROCHLORIDE

DMF 105291993

SIEGFRIED LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 111041994

RESOLUTION CHEMICALS LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 113561995

FARMAK ASInactiveSELEGILINE HYDROCHLORIDE USP

DMF 310242016

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2021	SUPPL -10	View Letter (PDF)
Aug 20, 2019	SUPPL -8	View Letter (PDF)
Aug 1, 2014	SUPPL -5	View Letter (PDF)
Jan 6, 2009	SUPPL -3	View Letter (PDF)
Jan 6, 2009	SUPPL -4	View Letter (PDF)
Jun 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.25MG

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 14, 2006

No patent or exclusivity listings for this strength.