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GLUCOTROL XL

NDA

GLIPIZIDE | N020329 | PFIZER 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

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 Glucotrol XL (2023)

Total Spending

$91K

Total Claims

1,442

Beneficiaries

401

Avg Cost/Unit

$0.57

Spending Trend

$967K(2019)→$845K(2020)→$697K(2021)→$158K(2022)→$91K(2023)

YoY Change:-20.4%

5yr CAGR:-29.7%

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

API Supply Chain13 active DMFs6 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCGLIPIZIDE USP

DMF 24181975

CAMBREX PROFARMACO MILANO SRLGLIPIZIDE

DMF 77101988

URQUIMA SAGLIPIZIDE

DMF 100461993

USV PRIVATE LTDGLIPIZIDE USP

DMF 123741997

AMSA SPAGLIPIZIDE

DMF 131011998

FERMION OYGLIPIZIDE

DMF 151742000

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTDGLIPIZIDE USP, NON-STERILE DRUG SUBSTANCE

DMF 195802006

SRI KRISHNA PHARMACEUTICALS LTDGLIPIZIDE USP

DMF 259932012

KREATIVE ORGANICS PRIVATE LTDGLIPIZIDE USP

DMF 275982013

UNICHEM LABORATORIES LTDGLIPIZIDE USP

DMF 284742014

OLON SPAGLIPIZIDE

DMF 293212015

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)GLIPIZIDE USP

DMF 349862020

DIJIA PHARMACEUTICAL GROUP CO LTDGLIPIZIDE

DMF 410352024

SUMITOMO CHEMICAL CO LTDInactiveGLIPIZIDE

DMF 88051990

FINE CHEMICALS CORP PTY LTDInactiveGLIPIZIDE

DMF 90701991

PROSTINEXInactiveGLIPIZIDE

DMF 92611991

ABBOTT LABORATORIESInactiveGLIPIZIDE

DMF 94211991

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveGLIPIZIDE

DMF 110241994

LUPIN LTDInactiveGLIPIZIDE USP

DMF 212102008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Sep 13, 2021	SUPPL -35	View Letter (PDF)
Aug 17, 2018	SUPPL -32	View Letter (PDF)
Aug 29, 2017	SUPPL -30	View Letter (PDF)
Oct 6, 2015	SUPPL -29	View Letter (PDF)
Oct 16, 2013	SUPPL -28	View Letter (PDF)
Feb 9, 2011	SUPPL -25	View Letter (PDF)
Oct 29, 2008	SUPPL -22	View Letter (PDF)
Sep 29, 2003	SUPPL -15	View Letter (PDF)
Apr 1, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 26, 1994

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 26, 1994

#003 — 2.5MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 10, 1999