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AMLODIPINE BESYLATE

NDA

AMLODIPINE BESYLATE | N022026 | SYNTHON PHARMACEUTICALS INC

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 Amlodipine Besylate (2023)

Total Spending

$407.2M

Total Claims

47,534,118

Beneficiaries

11,575,402

Avg Cost/Unit

$0.12

Spending Trend

$308.1M(2019)→$306.8M(2020)→$310.0M(2021)→$343.0M(2022)→$407.2M(2023)

YoY Change:+12.9%

5yr CAGR:+1.5%

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

API Supply Chain19 active DMFs14 inactive

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

TAPI NL BVAMLODIPINE BESYLATE

DMF 157772001

CADILA PHARMACEUTICALS LTDAMLODIPINE BESYLATE USP

DMF 169112003

CIPLA LTDAMLODIPINE BESYLATE USP

DMF 170322003

HETERO DRUGS LTDAMLODIPINE BESYLATE

DMF 187872005

APITORIA PHARMA PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 189652005

ORBION PHARMACEUTICALS PRIVATE LTDAMLODIPINE BESYLATE

DMF 195822006

GLOCHEM INDUSTRIES PRIVATE LTDAMLODIPINE BESYLATE

DMF 195912006

MATRIX PHARMACORP PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 201122007

SRINI PHARMACEUTICALS PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 226222009

ZYDUS LIFESCIENCES LTDAMLODIPINE BESYLATE USP

DMF 229302009

NOVARTIS PHARMACEUTICALS CORPAMLODIPINE BESYLATE (PROCESS 2)

DMF 229642009

IPCA LABORATORIES LTDAMLODIPINE BESYLATE USP

DMF 235892010

ARCH PHARMALABS LTDAMLODIPINE BESYLATE USP

DMF 236322010

GLOCHEM INDUSTRIES PRIVATE LTDAMLODIPINE BESYLATE (PROCESS 1)

DMF 278102013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAMLODIPINE BESYLATE USP

DMF 288862015

ALKEM LABORATORIES LTDAMLODIPINE BESYLATE USP

DMF 297032015

AURORE LIFE SCIENCES PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 343182019

ARENE LIFE SCIENCES PRIVATE LTDAMLODIPINE BESYLATE USP (PROCESS-I)

DMF 359972021

UNICHEM LABORATORIES LTDAMLODIPINE BESYLATE (ADP PROCESS) USP

DMF 404382024

MATRIX LABORATORIES LTDInactiveAMLODIPINE

DMF 165962003

LEK PHARMACEUTICALS DDInactiveAMLODIPINE BESYLATE

DMF 168872003

MYLAN LABORATORIES LTDInactiveAMLODIPINE BESYLATE USP (ADP)

DMF 172112004

GEDEON RICHTER LTDInactiveAMLODIPINE BESYLATE

DMF 175842004

SYNTHON BVInactiveAMLODIPINE BESYLATE MONOHYDRATE

DMF 188722005

EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET ASInactiveAMLODIPINE BESYLATE

DMF 202772007

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDInactiveAMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE)

DMF 212562008

ALP PHARM BEIJING CO LTDInactiveAMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE)

DMF 219512008

ESTEVE QUIMICA SAInactiveAMLODIPINE BESYLATE

DMF 223422008

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveAMLODIPINE BESYLATE

DMF 261322012

EGIS PHARMACEUTICALS PRIVATE LTD COInactiveAMLODIPINE BESYLATE API

DMF 279642014

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAMLODIPINE BESYLATE (PROCESS II)

DMF 283512014

HETERO DRUGS LTDInactiveAMLODIPINE BESYLATE (PROCESS-II)

DMF 307172016

ARENE LIFE SCIENCES PVT LTDInactiveAMLODIPINE BESYLATE USP

DMF 338732019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 4, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2.5MG BASE

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Sep 27, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Sep 27, 2007

#003 — EQ 10MG BASE

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Sep 27, 2007