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TREZIX

ANDA

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | A204785 | KEY THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
WraSer Pharmaceuticals, LLC - Cititzen Petition FDA-2011-P-0728 · 3 docket documents WraSer Pharmaceuticals, LLC submitted an ANDA Suitability Petition on October 5, 2011 under 21 CFR 314.93 requesting permission to file an abbreviated new drug application for a reformulated version of Trezix (Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Capsules) with reduced acetaminophen st	Other	2011-10-21	Granted	—

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

Medicare Part D Spending

CMS annual spending data for Trezix (2024)

Total Spending

$3K

Total Claims

Beneficiaries

Avg Cost/Unit

$4.58

Spending Trend

$211K(2019)→$297K(2020)→$220K(2021)→$103K(2022)→$57K(2023)→$3K(2024)

YoY Change:+4.2%

5yr CAGR:+1.9%

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
Dec 3, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 320.5MG;30MG;16MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 26, 2014

No patent or exclusivity listings for this strength.