Viewing data from:

PLAVIX

NDA

CLOPIDOGREL BISULFATE | N020839 | SANOFI AVENTIS US LLC

2 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Aspirin vs Clopidogrel After TAVR NCT05493657	N/A	Recruiting	Yonsei University	270	2023-02-02 → 2027-07-21

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Plavix (2023)

Total Spending

$7.2M

Total Claims

14,057

Beneficiaries

3,289

Avg Cost/Unit

$8.02

Spending Trend

$2.7M(2020)→$8.0M(2021)→$7.7M(2022)→$7.2M(2023)

YoY Change:+6.4%

5yr CAGR:+6.7%

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

API Supply Chain33 active DMFs26 inactive

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

SANOFI WINTHROP INDUSTRIECLOPIDOGREL BISULFATE FORM II

DMF 148092000

DR REDDYS LABORATORIES LTDCLOPIDOGREL BISULFATE [FORM-I] USP

DMF 160902002

TAPI NL BVCLOPIDOGREL BISULFATE USP

DMF 170092003

WOCKHARDT LTDCLOPIDOGREL BISULFATE USP (FORM-1)

DMF 192882006

APITORIA PHARMA PRIVATE LTDCLOPIDOGREL BISULFATE USP

DMF 194092006

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)CLOPIDOGREL BISULFATE USP

DMF 197442006

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)CLOPIDOGREL BISULFATE USP (FORM-I)

DMF 204442007

SUN PHARMACEUTICAL INDUSTRIES LTDCLOPIDOGREL BISULFATE USP (PROCESS-I)

DMF 210622007

MSN LABORATORIES PRIVATE LTDCLOPIDOGREL BISULFATE USP (FORM-1) [ROUTE CODE - "CR1"]

DMF 213092008

YUNG ZIP CHEMICAL IND CO LTDCLOPIDOGREL BISULFATE

DMF 222802008

MACLEODS PHARMACEUTICALS LTDCLOPIDOGREL BISULFATE USP

DMF 241102010

JUBILANT PHARMOVA LTDCLOPIDOGREL BISULFATE USP

DMF 244962011

HETERO DRUGS LTDCLOPIDOGREL BISULFATE (FORM-I)

DMF 249762011

ORCHID PHARMA LTDCLOPIDOGREL BISULFATE

DMF 252172011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDCLOPIDOGREL BISULFATE

DMF 254642011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCLOPIDOGREL BISULFATE USP

DMF 268902013

MSN ORGANICS PRIVATE LTDCLOPIDOGREL BISULFATE USP (FORM-II) [ROUTE CODE - 'CM2']

DMF 291392015

SUN PHARMACEUTICAL INDUSTRIES LTDCLOPIDOGREL BISULFATE USP (PROCESS-II)

DMF 301872016

VASUDHA PHARMA CHEM LTDCLOPIDOGREL BISULFATE USP

DMF 328752019

ZYDUS LIFESCIENCES LTDCLOPIDOGREL BISULFATE USP

DMF 336892019

CHEMECA DRUGS PRIVATE LTDCLOPIDOGREL BISULFATE USP

DMF 337102021

APITORIA PHARMA PRIVATE LTDCLOPIDOGREL BISULFATE USP (FORM II)

DMF 339162019

MSN LIFE SCIENCES PRIVATE LTDCLOPIDOGREL BISULFATE USP FORM II

DMF 342402019

METROCHEM API PRIVATE LTDCLOPIDOGREL BISULFATE USP

DMF 343342020

INNOVARE LABS PRIVATE LTDCLOPIDOGREL BISULFATE USP

DMF 346512020

ZHEJIANG LEPU PHARMACEUTICAL CO LTDCLOPIDOGREL BISULFATE

DMF 350812020

DR REDDYS LABORATORIES LTDCLOPIDOGREL BISULFATE FORM-II

DMF 355062020

ZYDUS LIFESCIENCES LTDCLOPIDOGREL BISULFATE USP (PROCESS-II)

DMF 360272021

ZYDUS LIFESCIENCES LTDCLOPIDOGREL BISULFATE USP (PROCESS-III)

DMF 360412021

IOL CHEMICALS AND PHARMACEUTICALS LTDCLOPIDOGREL BISULFATE USP

DMF 365342022

SIGNA SA DE CVCLOPIDOGREL BISULFATE USP

DMF 386952023

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDCLOPIDOGREL BISULFATE

DMF 398512024

ARENE LIFE SCIENCES PRIVATE LTDCLOPIDOGREL BISULFATE USP

DMF 403602024

SANOFI AVENTIS CHIMIEInactiveCLOPIDOGREL BISULFATE

DMF 124391997

SANOFI SYNTHELABO INCInactiveCLOPIDOGREL BISULFATE

DMF 124601997

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveCLOPIDOGREL BISULFATE FORM I

DMF 148492000

DR REDDYS LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE

DMF 157152001

ARCH PHARMALABS LTDInactiveCLOPIDOGREL BISULFATE (USP - XXVIII)

DMF 189302005

WANBURY LTDInactiveCLOPIDOGREL BISULFATE

DMF 204952007

CADILA HEALTHCARE LTDInactiveCLOPIDOGREL BISULFATE USP (FORM-I)

DMF 206502007

IPCA LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE USP FORM 1

DMF 209232007

IPCA LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE (FORM 1) USP (PROCESS-II)

DMF 212422008

ZACH SYSTEM SPAInactiveCLOPIDOGREL BISULFATE

DMF 220812008

USV PRIVATE LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 221092008

PHARMAZELL INDIA PRIVATE LTDInactiveCLOPIDOGREL BISULFATE

DMF 226192009

CADILA HEALTHCARE LTDInactiveCLOPIDOGREL BISULFATE USP (FORM-I) (CUE ROUTE)

DMF 234392010

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveCLOPIDOGREL BISULFATE

DMF 241302010

RPG LIFE SCIENCES LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 243282010

MYLAN LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 244032010

IND SWIFT LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 245862011

LUPIN LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 246252011

IPCA LABORATORIES LTDInactiveCLOPIDOGREL BISULFATE USP (XC4 PROCESS)

DMF 247672011

ALEMBIC PHARMACEUTICALS LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 248442011

SHANGHAI DONGYUE BIOCHEM CO LTDInactiveCLOPIDOGREL BISULFATE

DMF 249592011

ALP PHARM BEIJING CO LTDInactiveCLOPIDOGREL BISULFATE FORM II

DMF 275892013

HEC PHARM CO LTDInactiveCLOPIDOGREL BISULFATE NON-STERILE BULK DRUG SUBSTANCE

DMF 279172014

MSN PHARMACHEM PRIVATE LTDInactiveCLOPIDOGREL BISULFATE USP (FORM-1) [ROUTE CODE "CS1"]

DMF 280142014

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveCLOPIDOGREL BISULFATE USP

DMF 295292015

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDInactiveCLOPIDOGREL BISULFATE (FORM II)

DMF 350522020

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

Approval Letters

33 letters from Drugs@FDA

Date	Submission	Document
Sep 14, 2023	SUPPL -75	View Letter (PDF)
Sep 19, 2022	SUPPL -78	View Letter (PDF)
Mar 2, 2021	SUPPL -74	View Letter (PDF)
May 20, 2019	SUPPL -72	View Letter (PDF)
Oct 15, 2018	SUPPL -69	View Letter (PDF)
May 29, 2018	SUPPL -70	View Letter (PDF)
Jul 13, 2017	SUPPL -67	View Letter (PDF)
Sep 21, 2016	SUPPL -64	View Letter (PDF)
Sep 21, 2016	SUPPL -62	View Letter (PDF)
Jul 20, 2015	SUPPL -61	View Letter (PDF)
Dec 16, 2013	SUPPL -58	View Letter (PDF)
Sep 13, 2013	SUPPL -57	View Letter (PDF)
Dec 22, 2011	SUPPL -55	View Letter (PDF)
May 10, 2011	SUPPL -51	View Letter (PDF)
May 6, 2011	SUPPL -53	View Letter (PDF)
Feb 7, 2011	SUPPL -52	View Letter (PDF)
Aug 16, 2010	SUPPL -48	View Letter (PDF)
Mar 18, 2010	SUPPL -42	View Letter (PDF)
Jan 20, 2010	SUPPL -44	View Letter (PDF)
Aug 26, 2009	SUPPL -40	View Letter (PDF)
Sep 25, 2007	SUPPL -38	View Letter (PDF)
May 9, 2007	SUPPL -37	View Letter (PDF)
Aug 21, 2006	SUPPL -34	View Letter (PDF)
Aug 7, 2006	SUPPL -35	View Letter (PDF)
Oct 19, 2005	SUPPL -33	View Letter (PDF)
Apr 28, 2005	SUPPL -28	View Letter (PDF)
Apr 28, 2005	SUPPL -31	View Letter (PDF)
Apr 28, 2005	SUPPL -30	View Letter (PDF)
Oct 15, 2004	SUPPL -23	View Letter (PDF)
Oct 9, 2003	SUPPL -21	View Letter (PDF)
Oct 9, 2003	SUPPL -24	View Letter (PDF)
Feb 27, 2002	SUPPL -19	View Letter (PDF)
Jan 28, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 75MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 17, 1997

No patent or exclusivity listings for this strength.

#002 — EQ 300MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 20, 2007