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VUITY

NDA

PILOCARPINE HYDROCHLORIDE | N214028 | ABBVIE INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

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Today

10610518

Apr. 24, 2039

11285134

Apr. 24, 2039

D-187

Mar. 28, 2026

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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 | 2 NDCs

Highest NADAC/Unit

$31.39

per ml

Lowest NADAC/Unit

$23.39

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00074709804VUITY 1.25% EYE DROP	$31.39	ML	Brand	$25.29	2026-06-17
00074709806VUITY 1.25% EYE DROP	$23.39	ML	Brand	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$57.76

Highest Price

$114.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-7098-04VUITY 1.25% SOLN,OPH	$75.23	FSS	Abbvie US LLC	07/31/2030
00074-7098-04VUITY 1.25% SOLN,OPH	$57.76	Big4	Abbvie US LLC	07/31/2030
00074-7098-06VUITY 1.25% SOLN,OPH	$114.26	FSS	Abbvie US LLC	07/31/2030
00074-7098-06VUITY 1.25% SOLN,OPH	$87.74	Big4	Abbvie US LLC	07/31/2030

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

Medicare Part D Spending

CMS annual spending data for Vuity (2024)

Total Spending

$226K

Total Claims

2,220

Beneficiaries

915

Avg Cost/Unit

$28.53

Spending Trend

$5K(2021)→$454K(2022)→$283K(2023)→$226K(2024)

YoY Change:-6.4%

5yr CAGR:-2.1%

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

4 letters from Drugs@FDA

Date	Submission	Document
Apr 7, 2023	SUPPL -3	View Letter (PDF)
Mar 29, 2023	SUPPL -2	View Letter (PDF)
Aug 17, 2022	SUPPL -1	View Letter (PDF)
Oct 29, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.25%

RLD

2 patents1 exclusivity▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 28, 2021

Patents (2) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10610518	Apr 24, 2039	—	—	—		—
11285134	Apr 24, 2039	—	—	—		—

Exclusivities (1)

Code	Date	Status
D-187	Mar 28, 2026	Expired