Viewing data from:

EVOXAC

NDA

CEVIMELINE HYDROCHLORIDE | N020989 | COSETTE PHARMACEUTICALS INC

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

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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva NCT01690052	N/A	Completed	University of Kentucky	15	2009-01 → 2010-07
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer NCT00017511	Phase 3	Completed	Daiichi Sankyo	—	2001-06 → 2003-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$8.59

per ea

Lowest NADAC/Unit

$0.6871

per ea

Brand NDCs

Generic NDCs

Avg Brand: $8.59

Avg Generic: $0.6871

92% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713088301EVOXAC 30 MG CAPSULE	$8.59	EA	Brand	$0.6871	2026-07-01
63304047901CEVIMELINE HCL 30 MG CAPSULE	$0.6871	EA	Generic	—	2026-06-17
00713093701CEVIMELINE HCL 30 MG CAPSULE	$0.6871	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 | 2 NDCs (2 FSS)

Lowest Price

$80.59

Highest Price

$525.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-0883-01EVOXAC 30MG CAP	$525.29	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0937-01CEVIMELINE HCL 30MG CAP	$80.59	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

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

Medicare Part D Spending

CMS annual spending data for Evoxac (2024)

Total Spending

$1.0M

Total Claims

797

Beneficiaries

183

Avg Cost/Unit

$7.69

Spending Trend

$1.3M(2019)→$1.3M(2020)→$1.1M(2021)→$292K(2022)→$1.2M(2023)→$1.0M(2024)

YoY Change:-5.1%

5yr CAGR:-0.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

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

ISHIHARA SANGYO KAISHA LTDCEVIMELINE HYDROCHLORIDE

DMF 130741998

EXCELLA GMBH AND CO KGCEVIMELINE HYDROCHLORIDE

DMF 222002008

APOTEX INCCEVIMELINE HYDROCHLORIDE HEMIHYDRATE

DMF 225092009

MATRIX PHARMACORP PRIVATE LTDCEVIMELINE HYDROCHLORIDE USP

DMF 249492011

STHREE CHEMICALS LLCCEVIMELINE HYDROCHLORIDE USP

DMF 385772023

KALINTIS HEALTHCARE PVT LTDCEVIMELINE HYDROCHLORIDE USP

DMF 388802023

APICORE LLCCEVIMELINE HYDROCHLORIDE USP

DMF 402232024

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 28, 2006	SUPPL -8	View Letter (PDF)
Dec 16, 2005	SUPPL -6	View Letter (PDF)
Jan 11, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 30MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 11, 2000

No patent or exclusivity listings for this strength.