Viewing data from:

EDARBYCLOR

NDA

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE | N202331 | AZURITY PHARMACEUTICALS INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

Today

9066936

Mar. 26, 2028

9169238

Feb. 4, 2030

9387249

Jul. 1, 2031

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

4 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. et al v. Annora Pharma Private Limited 1:2025cv01493 3 patentsANDA 220703azilsartan medoxomil and chlorthalidone	D. Del.	2025-12-11	Active	—
Azurity Pharmaceuticals, Inc. et al v. Saba Ilac Sanayi ve Ticaret AS 1:2025cv00814 3 patentsANDA 217111azilsartan medoxomil and chlorthalidone	D. Del.	2025-07-02	Active	—
Azurity Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals, Inc. 1:2023cv01080 5 patentsANDA 218737azilsartan medoxomil and chlorthalidone	D. Del.	2023-09-29	Terminated 2024-05-14	—
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	—

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 Edarbyclor (2023)

Total Spending

$27.0M

Total Claims

64,258

Beneficiaries

13,422

Avg Cost/Unit

$7.68

Spending Trend

$22.6M(2019)→$25.7M(2020)→$27.2M(2021)→$27.4M(2022)→$27.0M(2023)

YoY Change:+4.5%

5yr CAGR:+4.7%

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

API Supply Chain4 active DMFs

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

LINHAI TIANYU PHARMACEUTICAL CO LTDAZILSARTAN

DMF 396542024

REYOUNG CORPORATIONAZILSARTAN

DMF 397532024

JIANGXI SYNERGY PHARMACEUTICAL CO LTDAZILSARTAN

DMF 404332024

WUHAN RS PHARMACEUTICALS CO LTDAZILSARTAN

DMF 406452024

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 15, 2023	SUPPL -16	View Letter (PDF)
Oct 26, 2016	SUPPL -11	View Letter (PDF)
Apr 17, 2015	SUPPL -7	View Letter (PDF)
Jul 24, 2014	SUPPL -6	View Letter (PDF)
Apr 21, 2014	SUPPL -5	View Letter (PDF)
Oct 4, 2012	SUPPL -2	View Letter (PDF)
Dec 27, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 40MG MEDOXOMIL;12.5MG

RLDAB

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 20, 2011

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9066936	Mar 26, 2028	—	—	Yes	—	—
9169238	Feb 4, 2030	—	—	Yes	—	—
9387249	Jul 1, 2031	—	—	—		—

#002 — EQ 40MG MEDOXOMIL;25MG

RLDAB

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 20, 2011