Viewing data from:

SALAGEN

NDA

PILOCARPINE HYDROCHLORIDE | N020237 | ADVANZ PHARMA (US) CORP

2 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 Salagen (2023)

Total Spending

$43K

Total Claims

163

Beneficiaries

Avg Cost/Unit

$1.79

Spending Trend

$65K(2020)→$35K(2021)→$34K(2022)→$43K(2023)

YoY Change:+0.9%

5yr CAGR:+6.1%

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

API Supply Chain4 active DMFs4 inactive

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

ANIDRO DO BRASIL EXTRACOES SAPILOCARPINE HYDROCHLORIDE USP

DMF 100251992

SPERA NEXUS INCPILOCARPINE HYDROCHLORIDE

DMF 123881997

SOURCETECH QUIMICA LTDAPILOCARPINE HYDROCHLORIDE

DMF 168732003

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPILOCARPINE HYDROCHLORIDE

DMF 389012023

LINNEA PHYTOCHEMICALSInactivePILOCARPINE HYDROCHLORIDE

DMF 75361988

ANIDRO DO BRASIL EXTRACOES SAInactivePILOCARPINE HYDROCHLORIDE

DMF 84531990

BOEHRINGER INGELHEIM PHARMA KGInactivePILOCARPINE HYDROCHLORIDE

DMF 93321991

PVP SOCIEDADE ANONIMAInactivePILOCARPINE HYDROCHLORIDE

DMF 108611994

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 7, 2004	SUPPL -4	View Letter (PDF)
Jun 7, 2004	SUPPL -2	View Letter (PDF)
May 29, 2003	SUPPL -12	View Letter (PDF)
Jun 10, 2002	SUPPL -9	View Letter (PDF)
Jun 10, 2002	SUPPL -8	View Letter (PDF)
Feb 11, 1998	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 22, 1994

No patent or exclusivity listings for this strength.

#002 — 7.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 18, 2003