Viewing data from:

LOPID

NDA

GEMFIBROZIL | N018422 | PFIZER PHARMACEUTICALS 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 Lopid (2023)

Total Spending

$8K

Total Claims

Beneficiaries

Avg Cost/Unit

$1.24

Spending Trend

$207K(2019)→$85K(2020)→$102K(2021)→$14K(2022)→$8K(2023)

YoY Change:-22.9%

5yr CAGR:-33.1%

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

API Supply Chain8 active DMFs13 inactive

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

TAPI NL BVGEMFIBROZIL USP

DMF 74451988

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLGEMFIBROZIL

DMF 90581991

ISOCHEM SASGEMFIBROZIL

DMF 180562005

HIKAL LTDGEMFIBROZIL API

DMF 188152005

ZHEJIANG EXCEL PHARMACEUTICAL CO LTDGEMFIBROZIL USP

DMF 194072006

APITORIA PHARMA PRIVATE LTDGEMFIBROZIL USP

DMF 194542006

PIRAMAL PHARMA LTDGEMFIBROZIL

DMF 204372007

CADILA PHARMACEUTICALS LTDGEMFIBROZIL USP

DMF 349332020

SIBEFAT SPAInactiveGEMFIBROZIL USP

DMF 68741987

BLASCHIM SPAInactiveGEMFIBROZIL USP

DMF 72121987

DINAMITE DIPHARMA SPAInactiveGEMFIBROZIL

DMF 74301988

FRANCIS SPAInactiveGEMFIBROZIL

DMF 77641988

SIEGFRIED AGInactiveGEMFIBROZIL

DMF 90711991

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveGEMFIBROZIL

DMF 97961992

GANES CHEMICALS INC PENNSVILLE DIVInactiveGEMFIBROZIL

DMF 98801992

SIGNA SA DE CVInactiveGEMFIBROZIL USP

DMF 154122001

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveGEMFIBROZIL

DMF 181242005

SHANGHAI SUNVE PHARMACEUTICAL CO LTDInactiveGEMFIBROZIL

DMF 181322005

SYMED LABS LTDInactiveGEMFIBROZIL

DMF 184642005

SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTDInactiveGEMFIBROZIL

DMF 203232007

SIGNA SA DE CVInactiveGEMFIBROZIL USP (GEA PROCESS)

DMF 261462011

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2020	SUPPL -59	View Letter (PDF)
Apr 27, 2018	SUPPL -58	View Letter (PDF)
Apr 19, 2017	SUPPL -56	View Letter (PDF)
Apr 8, 2016	SUPPL -55	View Letter (PDF)
Nov 7, 2014	SUPPL -54	View Letter (PDF)
Nov 6, 2013	SUPPL -53	View Letter (PDF)
Sep 29, 2010	SUPPL -50	View Letter (PDF)
Jul 17, 2009	SUPPL -48	View Letter (PDF)
Jun 8, 2004	SUPPL -41	View Letter (PDF)
Jun 8, 2004	SUPPL -40	View Letter (PDF)
Apr 7, 2004	SUPPL -45	View Letter (PDF)
Jan 15, 2003	SUPPL -43	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 600MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 1986