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NDA

AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | N219423 | AZURITY PHARMACEUTICALS INC

3 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

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2032

2033

2034

2035

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2038

Today

Jan. 23, 2038

Jan. 23, 2038

Jan. 23, 2038

Jan. 23, 2038

Jun. 5, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2026	SUPPL -2	View Letter (PDF)
Jun 6, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1.25MG BASE;0.625MG;10MG

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Jun 5, 2025

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10322117	Jan 23, 2038	—	—	Yes	—	—
12465599	Jan 23, 2038	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NP	Jun 5, 2028	Active

#002 — EQ 2.5MG BASE;1.25MG;20MG

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jun 5, 2025

#003 — EQ 5MG BASE;2.5MG;40MG

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Jun 5, 2025