Viewing data from:

EDARBI

NDA

AZILSARTAN KAMEDOXOMIL | N200796 | AZURITY PHARMACEUTICALS INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

9066936

Mar. 26, 2028

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

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. et al v. Aurobindo Pharma Ltd. 1:2025cv01507 1 patentANDA 220957azilsartan medoxomil	D. Del.	2025-12-15	Active	—
Azurity Pharmaceuticals, Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al 1:2023cv00833 5 patentsANDA 218658, 218451Azilsartan Medoxomil (and Chlorthalidone in combination product)	D. Del.	2023-08-02	Terminated 2024-12-30	—
Arbor Pharmaceuticals, LLC et al v. Saba Ilac Sanayi ve Ticaret AS 1:2022cv00353 3 patentsANDA 216699azilsartan medoxomil	D. Del.	2022-03-18	Terminated 2024-02-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Edarbi (2023)

Total Spending

$36.8M

Total Claims

83,861

Beneficiaries

17,111

Avg Cost/Unit

$7.80

Spending Trend

$28.4M(2019)→$32.5M(2020)→$34.5M(2021)→$36.0M(2022)→$36.8M(2023)

YoY Change:+4.4%

5yr CAGR:+4.6%

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

API Supply Chain12 active DMFs

11 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDAZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"]

DMF 280922014

HEC PHARM CO LTDAZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE

DMF 284522014

HONOUR LAB LTDAZILSARTAN KAMEDOXOMIL

DMF 318952017

LUPIN MANUFACTURING SOLUTIONS LTDAZILSARTAN KAMEDOXOMIL

DMF 337322019

APITORIA PHARMA PRIVATE LTDAZILSARTAN KAMEDOXOMIL

DMF 352392020

PIRAMAL PHARMA LTDAZILSARTAN KAMEDOXOMIL

DMF 357702021

MSN LABORATORIES PRIVATE LTDAZILSARTAN KAMEDOXOMIL

DMF 359322021

JIANGXI SYNERGY PHARMACEUTICAL CO LTDAZILSARTAN KAMEDOXOMIL

DMF 376932024

ALKEM LABORATORIES LTDAZILSARTAN KAMEDOXOMIL

DMF 380472023

CHROMO LABORATORIES INDIA PRIVATE LTDAZILSARTAN KAMEDOXOMIL

DMF 385832024

LINHAI TIANYU PHARMACEUTICAL CO LTDAZILSARTAN KAMEDOXOMIL

DMF 421242025

XUZHOU WANBANG JINQIAO PHARMA CO LTDAZILSARTAN KAMEDOXOMIL

DMF 430042025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2024	SUPPL -13	View Letter (PDF)
Mar 10, 2020	SUPPL -12	View Letter (PDF)
Oct 26, 2016	SUPPL -9	View Letter (PDF)
Aug 4, 2014	SUPPL -6	View Letter (PDF)
Apr 21, 2014	SUPPL -5	View Letter (PDF)
Oct 4, 2012	SUPPL -3	View Letter (PDF)
Dec 15, 2011	SUPPL -2	View Letter (PDF)
Apr 15, 2011	SUPPL -1	View Letter (PDF)
Mar 2, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 40MG MEDOXOMIL

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Feb 25, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9066936	Mar 26, 2028	—	—	Yes	—	—

#002 — EQ 80MG MEDOXOMIL

RLDAB

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Feb 25, 2011