Viewing data from:

AZOR

NDA

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | N022100 | COSETTE PHARMACEUTICALS INC

4 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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$19.63

per ea

Lowest NADAC/Unit

$15.32

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713087230AZOR 5-40 MG TABLET	$19.63	EA	Brand	$0.2934	2026-07-01
00713087330AZOR 10-40 MG TABLET	$19.54	EA	Brand	$0.3424	2026-07-01
00713087030AZOR 5-20 MG TABLET	$15.32	EA	Brand	$0.2476	2026-07-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$0.01

Highest Price

$100.78

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-0873-30AZOR TABLETS 10MG/40MG	$0.01	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0870-30AZOR TABLETS 5MG/20MG	$100.78	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0871-30AZOR TABLETS 10MG/20MG	$55.68	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0872-30AZOR TABLETS 5MG/40MG	$0.01	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

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

Medicare Part D Spending

CMS annual spending data for Azor (2024)

Total Spending

$2.9M

Total Claims

3,507

Beneficiaries

720

Avg Cost/Unit

$13.84

Spending Trend

$5.3M(2019)→$4.9M(2020)→$4.4M(2021)→$3.8M(2022)→$3.3M(2023)→$2.9M(2024)

YoY Change:+3.0%

5yr CAGR:+5.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Oct 5, 2020	SUPPL -39	View Letter (PDF)
Jan 13, 2017	SUPPL -33	View Letter (PDF)
Dec 13, 2016	SUPPL -30	View Letter (PDF)
Nov 2, 2016	SUPPL -32	View Letter (PDF)
Sep 24, 2014	SUPPL -26	View Letter (PDF)
Jul 3, 2014	SUPPL -25	View Letter (PDF)
Jun 18, 2014	SUPPL -24	View Letter (PDF)
Jul 5, 2013	SUPPL -22	View Letter (PDF)
Dec 11, 2012	SUPPL -20	View Letter (PDF)
Oct 3, 2012	SUPPL -19	View Letter (PDF)
Jan 20, 2012	SUPPL -16	View Letter (PDF)
Nov 16, 2011	SUPPL -13	View Letter (PDF)
Nov 3, 2011	SUPPL -14	View Letter (PDF)
May 24, 2011	SUPPL -10	View Letter (PDF)
May 24, 2011	SUPPL -12	View Letter (PDF)
May 14, 2009	SUPPL -2	View Letter (PDF)
Aug 12, 2008	SUPPL -3	View Letter (PDF)
Oct 4, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 5MG BASE;20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 26, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 2007

#003 — EQ 10MG BASE;20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 2007

#004 — EQ 10MG BASE;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 2007