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CONJUPRI

NDA

LEVAMLODIPINE MALEATE | N212895 | CSPC OUYI PHARMACEUTICAL CO LTD

3 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

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

Medicare Part D Spending

CMS annual spending data for Levamlodipine Maleate (2023)

Total Spending

$5K

Total Claims

Beneficiaries

Avg Cost/Unit

$2.24

Spending Trend

$1K(2022)→$5K(2023)

YoY Change:+64.0%

5yr CAGR:+64.0%

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1.25MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 19, 2019

No patent or exclusivity listings for this strength.

#002 — EQ 2.5MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 19, 2019

#003 — EQ 5MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 19, 2019