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CADUET

NDA

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | N021540 | PHARMACIA AND UPJOHN CO LLC

11 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

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 Caduet (2023)

Total Spending

$386K

Total Claims

294

Beneficiaries

Avg Cost/Unit

$21.88

Spending Trend

$3.8M(2019)→$3.1M(2020)→$1.4M(2021)→$927K(2022)→$386K(2023)

YoY Change:+11.4%

5yr CAGR:+7.3%

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

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
May 20, 2024	SUPPL -49	View Letter (PDF)
Jan 8, 2021	SUPPL -46	View Letter (PDF)
Dec 16, 2020	SUPPL -47	View Letter (PDF)
Sep 29, 2020	SUPPL -48	View Letter (PDF)
Dec 23, 2019	SUPPL -45	View Letter (PDF)
May 13, 2019	SUPPL -44	View Letter (PDF)
Oct 29, 2018	SUPPL -43	View Letter (PDF)
Oct 29, 2018	SUPPL -42	View Letter (PDF)
May 29, 2018	SUPPL -41	View Letter (PDF)
Jun 27, 2017	SUPPL -39	View Letter (PDF)
Mar 25, 2015	SUPPL -36	View Letter (PDF)
Feb 19, 2015	SUPPL -37	View Letter (PDF)
May 27, 2014	SUPPL -34	View Letter (PDF)
Nov 12, 2013	SUPPL -31	View Letter (PDF)
Nov 12, 2013	SUPPL -30	View Letter (PDF)
Nov 6, 2012	SUPPL -28	View Letter (PDF)
Jul 30, 2012	SUPPL -26	View Letter (PDF)
Jul 30, 2012	SUPPL -23	View Letter (PDF)
Feb 23, 2010	SUPPL -19	View Letter (PDF)
Nov 24, 2009	SUPPL -18	View Letter (PDF)
Jun 2, 2008	SUPPL -14	View Letter (PDF)
Sep 25, 2007	SUPPL -11	View Letter (PDF)
Sep 25, 2007	SUPPL -9	View Letter (PDF)
Sep 18, 2006	SUPPL -6	View Letter (PDF)
Apr 20, 2006	SUPPL -8	View Letter (PDF)
Sep 29, 2004	SUPPL -3	View Letter (PDF)
Feb 3, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (11)

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#001 — EQ 5MG BASE;EQ 10MG BASE

RLDAB

0 patents0 exclusivities▴