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PLENDIL

NDA

FELODIPINE | N019834 | ASTRAZENECA PHARMACEUTICALS LP

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

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

Medicare Part D Spending

CMS annual spending data for Felodipine ER (2023)

Total Spending

$13.2M

Total Claims

330,362

Beneficiaries

81,200

Avg Cost/Unit

$0.51

Spending Trend

$17.4M(2019)→$16.8M(2020)→$15.2M(2021)→$13.0M(2022)→$13.2M(2023)

YoY Change:+7.3%

5yr CAGR:-3.3%

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

API Supply Chain6 active DMFs10 inactive

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

CIPLA LTDFELODIPINE USP

DMF 114491995

MEDICHEM SAFELODIPINE

DMF 140991999

EVERLIGHT CHEMICAL INDUSTRIAL CORPFELODIPINE

DMF 170302003

APITORIA PHARMA PRIVATE LTDFELODIPINE USP, NON-STERILE DRUG SUBSTANCE

DMF 208902007

ORBION PHARMACEUTICALS PRIVATE LTDFELODIPINE (NON-STERILE BULK API)

DMF 213542008

ALEMBIC PHARMACEUTICALS LTDFELODIPINE USP

DMF 253732011

ESTEVE QUIMICA SAInactiveFELODIPINE

DMF 122481996

WOCKHARDT LTDInactiveFELODIPINE

DMF 132551998

YANGZHOU PHARMACEUTICAL FACTORYInactiveFELODIPINE

DMF 147862000

PCASInactiveFELODIPINE

DMF 185102005

YANGZHOU PHARMACEUTICAL CO LTDInactiveFelodipine USP

DMF 210512007

KOREA UNITED PHARMACEUTICALS INCInactiveFELODIPINE

DMF 216642008

HAINAN POLY PHARMACEUTICAL CO LTDInactiveFELODIPINE EXTENDED RELEASE TABLETS

DMF 237242010

EMCURE PHARMACEUTICALS LTDInactiveFELODIPINE USP

DMF 246812011

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDInactiveFELODIPINE

DMF 254052011

HEC PHARM USA INCInactiveFELODIPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 268112013

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2012	SUPPL -25	View Letter (PDF)
Jun 14, 2004	SUPPL -9	View Letter (PDF)
Jun 10, 2004	SUPPL -22	View Letter (PDF)
May 22, 2002	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 1991

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 1991

#004 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 22, 1994