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GLIMEPIRIDE

ANDA

GLIMEPIRIDE | A076802 | SENORES PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Glimepiride (2023)

Total Spending

$63.0M

Total Claims

4,698,592

Beneficiaries

1,187,344

Avg Cost/Unit

$0.13

Spending Trend

$75.7M(2019)→$71.4M(2020)→$66.3M(2021)→$60.3M(2022)→$63.0M(2023)

YoY Change:+9.7%

5yr CAGR:-2.9%

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

API Supply Chain14 active DMFs6 inactive

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

CHONGQING CARELIFE PHARMACEUTICAL CO LTDGLIMEPIRIDE USP

DMF 158822002

USV PRIVATE LTDGLIMEPIRIDE USP

DMF 167132003

DR REDDYS LABORATORIES LTDGLIMEPIRIDE USP

DMF 169832003

ALIVUS LIFE SCIENCES LTDGLIMEPIRIDE USP

DMF 175942004

HETERO DRUGS LTDGLIMEPIRIDE

DMF 176562004

IPCA LABORATORIES LTDGLIMEPIRIDE USP

DMF 200372006

INDOCO REMEDIES LTDGLIMEPIRIDE USP

DMF 225652009

SHANDONG XINHUA PHARMACEUTICAL CO LTDGLIMEPIRIDE

DMF 323192017

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDGLIMEPIRIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 326172018

MSN LIFE SCIENCES PRIVATE LTDGLIMEPIRIDE USP

DMF 357612021

MICRO LABS LTDGLIMEPIRIDE USP

DMF 372212022

EUROAPI GERMANY GMBHGLIMEPIRIDE (PROCESS 2)

DMF 373182022

MEDILUX LABORATORIES PVT LTDGLIMEPIRIDE USP

DMF 401832024

SHANDONG XINHUA PHARMACEUTICAL CO LTDGLIMEPIRIDE (II)

DMF 403222024

MEDICHEM SAInactiveGLIMEPIRIDE

DMF 167362003

ZACH SYSTEM SPAInactiveGLIMEPIRIDE

DMF 170482003

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGLIMEPIRIDE

DMF 172882004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGLIMEPIRIDE USP

DMF 224362009

HUBEI HAOSUN PHARMACEUTICAL CO LTDInactiveGLIMEPIRIDE

DMF 225612009

DISHMAN CARBOGEN AMCIS LTDInactiveGLIMEPIRIDE

DMF 230052009

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 11, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 6, 2005

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 6, 2005

#003 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 6, 2005