Viewing data from:

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

4 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk NCT00412113	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	245	2007-01 → 2008-04
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition NCT02295046	Phase 1	Completed	Dr. Reddy's Laboratories Limited	80	2011-10 → 2011-11
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition NCT02292069	Phase 1	Completed	Dr. Reddy's Laboratories Limited	90	2011-09 → 2011-10
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors NCT00407537	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	1,531	2007-03 → 2009-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 11 NDCs

Highest NADAC/Unit

$5.01

per ea

Lowest NADAC/Unit

$0.9044

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993026530AMLODIPINE-ATORVAST 2.5-40 MG	$5.01	EA	Generic	—	2026-06-17
66993026430AMLODIPINE-ATORVAST 2.5-20 MG	$4.50	EA	Generic	—	2026-04-22
66993026330AMLODIPINE-ATORVAST 2.5-10 MG	$3.08	EA	Generic	—	2026-06-17
66993027330AMLODIPINE-ATORVAST 10-80 MG	$1.67	EA	Generic	—	2026-06-17
66993026930AMLODIPINE-ATORVAST 5-80 MG	$1.44	EA	Generic	—	2026-06-17
66993027230AMLODIPINE-ATORVAST 10-40 MG	$1.43	EA	Generic	—	2026-06-17

Showing 6 of 11 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 38 NDCs (19 FSS, 19 Big4)

Lowest Price

$1.04

Highest Price

$372.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-6323-30CADUET 5MG/20MG TAB	$372.15	FSS	Mylan Specialty L.P.	01/14/2027
00069-6323-30CADUET 5MG/20MG TAB	$372.15	Big4	Mylan Specialty L.P.	01/14/2027
00069-7654-30CADUET 10MG/40MG TAB	$372.15	FSS	Mylan Specialty L.P.	01/14/2027
00069-7654-30CADUET 10MG/40MG TAB	$372.15	Big4	Mylan Specialty L.P.	01/14/2027
66993-0265-30AMLODIPINE BESYLATE 2.5MG/ATORVASTATIN 40MG T	$104.92	FSS	Prasco, LLC	06/30/2026
66993-0265-30AMLODIPINE BESYLATE 2.5MG/ATORVASTATIN 40MG T	$60.03	Big4	Prasco, LLC	06/30/2026

Showing 6 of 38 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Caduet (2024)

Total Spending

$395K

Total Claims

248

Beneficiaries

Avg Cost/Unit

$21.92

Spending Trend

$3.8M(2019)→$3.1M(2020)→$1.4M(2021)→$927K(2022)→$386K(2023)→$395K(2024)

YoY Change:+0.2%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2024). 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▴