Viewing data from:

ISOPTO CARPINE

NDA

PILOCARPINE HYDROCHLORIDE | N200890 | SANDOZ 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Alcon Research, Ltd. - Citizen Petition FDA-2012-P-0431 · 3 docket documents Alcon Research, Ltd. filed this citizen petition requesting that the FDA take immediate enforcement action against Akorn Incorporated for marketing unapproved pilocarpine hydrochloride ophthalmic solution products in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act	Other	2012-05-07	Denied	—

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

$3.42

per ml

Lowest NADAC/Unit

$3.10

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314020615PILOCARPINE 4% EYE DROPS	$3.42	ML	Generic	—	2026-06-17
61314020315PILOCARPINE 1% EYE DROPS	$3.10	ML	Generic	—	2026-06-17
61314020415PILOCARPINE 2% EYE DROPS	$3.10	ML	Generic	—	2026-06-17

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

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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 12, 2010	SUPPL -1	View Letter (PDF)
Jun 29, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010

No patent or exclusivity listings for this strength.

#002 — 2%

RLDAT

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010

#003 — 4%

RLDAT

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010