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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Axar Laboratories, Inc. FDA-2025-P-1104 · 10 docket documents Axar Laboratories, Inc. filed this citizen petition on April 17, 2025, challenging the patent term extension eligibility for VYNDAQEL (tafamidis meglumine, NDA 211996) by requesting that the FDA Commissioner determine the applicant (Scripps Research Institute, FoldRx Pharmaceuticals, LLC, and Pfizer	Other	2025-04-22	Denied	Axar Laboratories, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

32 trials from ClinicalTrials.gov — 1 recruiting, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pilocarpine Use After Kahook Goniotomy NCT03933631	Phase 3	Recruiting	Montefiore Medical Center	142	2019-05-01 → 2028-12
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer NCT00656513	Phase 2/3	Completed	Radiation Therapy Oncology Group	196	2008-09 → 2014-11
First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology NCT02420782	Phase 1	Completed	Astellas Pharma Europe B.V.	116	2015-05 → 2016-05
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)NCT00762645	Phase 4	Completed	Alcon Research	30	2007-02 → 2008-05
Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat NCT02935894	N/A	Completed	USDA, Western Human Nutrition Research Center	14	2016-11-28 → 2017-06-08
Dose, Effects and Characteristics of Pilocarpine NCT00803803	Phase 4	Completed	Wills Eye	37	1978-08 → 1979-12
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions NCT00618059	N/A	Completed	Roxane Laboratories	28	2004-08 → 2004-08
A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment NCT00438048	Phase 4	Completed	Pontificia Universidad Catolica de Chile	76	2006-11 → 2008-05
A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia NCT03857542	Phase 3	Completed	Allergan	427	2019-03-01 → 2020-09-10
Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva NCT01690052	N/A	Completed	University of Kentucky	15	2009-01 → 2010-07

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

$0.3154

per ea

Lowest NADAC/Unit

$0.3028

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68084092825PILOCARPINE HCL 5 MG TABLET	$0.3154	EA	Generic	—	2026-06-17
00228280111PILOCARPINE HCL 5 MG TABLET	$0.3154	EA	Generic	—	2026-06-17
00228283711PILOCARPINE HCL 7.5 MG TABLET	$0.3028	EA	Generic	—	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 | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$4.07

Highest Price

$222.59

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68084-0928-25PILOCARPINE HCL 5MG TAB	$51.50	FSS	Amerisource Health Services LLC dba American Health Packaging	09/14/2028
68084-0928-25PILOCARPINE HCL 5MG TAB	$42.78	Big4	Amerisource Health Services LLC dba American Health Packaging	09/14/2028
00228-2801-11PILOCARPINE HCL 5MG TAB	$4.07	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00228-2801-11PILOCARPINE HCL 5MG TAB	$4.07	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00228-2837-11PILOCARPINE HCL 7.5MG TAB	$56.54	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00228-2837-11PILOCARPINE HCL 7.5MG TAB	$17.61	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Salagen (2024)

Total Spending

$31K

Total Claims

136

Beneficiaries

Avg Cost/Unit

$1.74

Spending Trend

$65K(2020)→$35K(2021)→$34K(2022)→$43K(2023)→$31K(2024)

YoY Change:-2.6%

5yr CAGR:+3.8%

Source: CMS Medicare Part D Spending by Drug (2024). 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