Viewing data from:

KONVOMEP

NDA

OMEPRAZOLE; SODIUM BICARBONATE | N213593 | AZURITY PHARMACEUTICALS INC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Jul. 16, 2039

Jul. 16, 2039

Jul. 16, 2039

Mar. 1, 2040

Jul. 16, 2039

Jul. 16, 2039

Jul. 16, 2039

Jul. 16, 2039

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

9 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study NCT00693225	Phase 4	Completed	Yvonne Romero	91	2008-01 → 2010-12
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)NCT00765206	Phase 3	Completed	Bayer	60	2008-05 → 2008-08
Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets NCT03100838	Phase 1	Completed	Food and Drug Administration (FDA)	64	2017-03-20 → 2018-04-06
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)NCT00674115	Phase 3	Completed	Bayer	60	2008-04 → 2008-06
Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)NCT01005719	Phase 3	Completed	Bayer	63	2009-09 → 2010-01
A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12)NCT01337804	Phase 1	Completed	Bayer	50	2011-01 → 2011-01
Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)NCT01587885	Phase 4	Completed	Bayer	48	2012-01 → 2012-05
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill NCT00045799	Phase 3	Completed	Bausch Health Americas, Inc.	354	2002-05 → 2003-05
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus NCT01129778	N/A	Terminated	Stanford University	27	2009-11 → 2010-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$2.08

per ml

Lowest NADAC/Unit

$1.24

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65628027203KONVOMEP 2-84 MG/ML ORAL SUSP	$2.08	ML	Brand	—	2026-10-21
65628027205KONVOMEP 2-84 MG/ML ORAL SUSP	$1.77	ML	Brand	—	2026-10-21
65628027210KONVOMEP 2-84 MG/ML ORAL SUSP	$1.24	ML	Brand	—	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$128.63

Highest Price

$364.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
65628-0272-03KONVOMEP 90ML	$128.63	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
65628-0272-03KONVOMEP 90ML	$182.12	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
65628-0272-05KONVOMEP 150ML	$184.57	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
65628-0272-05KONVOMEP 150ML	$260.18	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
65628-0272-10KONVOMEP 300ML	$257.18	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
65628-0272-10KONVOMEP 300ML	$364.25	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Konvomep (2024)

Total Spending

$4.5M

Total Claims

10,159

Beneficiaries

1,959

Avg Cost/Unit

$1.41

Spending Trend

$1.9M(2023)→$4.5M(2024)

YoY Change:-3.5%

5yr CAGR:-3.5%

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 1, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/ML;84MG/ML

RLD

8 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Aug 30, 2022

Patents (8) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10751333	Jul 16, 2039	—	—	Yes	—	—
11103492	Jul 16, 2039	—	—	Yes	—	—
11633478	Jul 16, 2039	—	—	Yes	—	—
11771686	Mar 1, 2040	—	—	—		—
11911473	Jul 16, 2039	—	—	—		—
12042539	Jul 16, 2039	—	—	Yes	—	—
12329752	Jul 16, 2039	—	—	Yes	—	—
12440566	Jul 16, 2039	—	—	Yes	—	—