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ZEGERID

NDA

OMEPRAZOLE; SODIUM BICARBONATE | N021636 | SALIX PHARMACEUTICALS INC

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

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5164 Hyman, Phelps & McNamara, P.C. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare omeprazole and sodium bicarbonate for oral suspension in a new 30 mg/packet; 1.68 mg/packet s	Suitability	2024-11-05	Open	Hyman

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zegerid (2023)

Total Spending

$8.5M

Total Claims

1,457

Beneficiaries

290

Avg Cost/Unit

$114.59

Spending Trend

$8.8M(2019)→$8.7M(2020)→$8.0M(2021)→$8.5M(2022)→$8.5M(2023)

YoY Change:+0.5%

5yr CAGR:+1.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2023	SUPPL -25	View Letter (PDF)
Mar 7, 2022	SUPPL -24	View Letter (PDF)
Nov 30, 2020	SUPPL -22	View Letter (PDF)
Sep 25, 2019	SUPPL -20	View Letter (PDF)
Jun 14, 2018	SUPPL -19	View Letter (PDF)
Oct 26, 2016	SUPPL -17	View Letter (PDF)
Dec 24, 2014	SUPPL -16	View Letter (PDF)
Mar 4, 2014	SUPPL -15	View Letter (PDF)
Nov 14, 2012	SUPPL -12	View Letter (PDF)
Apr 23, 2012	SUPPL -13	View Letter (PDF)
Dec 13, 2011	SUPPL -11	View Letter (PDF)
May 25, 2011	SUPPL -10	View Letter (PDF)
Sep 8, 2010	SUPPL -9	View Letter (PDF)
Jan 29, 2010	SUPPL -8	View Letter (PDF)
Jun 16, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Jun 15, 2004

No patent or exclusivity listings for this strength.

#002 — 40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Dec 21, 2004