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HYCODAN

NDA

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | N005213 | GENUS LIFESCIENCES 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Hycodan (2023)

Total Spending

$234.51

Total Claims

Beneficiaries

—

Avg Cost/Unit

$0.11

Spending Trend

$234.73(2021)→$932.64(2022)→$234.51(2023)

YoY Change:-6.3%

5yr CAGR:-4.3%

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAA

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 26, 1988

No patent or exclusivity listings for this strength.

#002 — 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAA

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Jul 26, 1988