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VAZALORE

NDA

ASPIRIN | N203697 | PLX PHARMA INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

Today

Sep. 29, 2032

Sep. 29, 2032

Sep. 29, 2032

Sep. 29, 2032

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

API Supply Chain7 active DMFs10 inactive

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

SHANDONG XINHUA PHARMACEUTICAL CO LTDASPIRIN

DMF 107301994

THE ANDHRA SUGARS LTDASPIRIN USP

DMF 163452002

THE ANDHRA SUGARS LTDASPIRIN STARCH GRANULES

DMF 178162004

SHANDONG XINHUA PHARMACEUTICAL CO LTDASPIRIN REFINED

DMF 268442013

HEBEI JINGYE MEDICAL TECHNOLOGY CORP LTDASPIRIN

DMF 330102018

ZYDUS LIFESCIENCES LTDASPIRIN USP

DMF 353152020

JQC HUAYIN PHARMACEUTICAL CO LTDASPIRIN

DMF 386692023

ELI LILLY AND COInactiveASPIRIN CAPSULES 325MG

DMF 17741971

RHODIA INCInactiveASPIRIN AND ASPIRIN STARCH GRANULATION

DMF 58481985

DOW CHEMICAL COInactiveASPIRIN USP

DMF 59011985

ILKIM ASInactiveASPIRIN USP

DMF 60191985

ATABAY KIMYA SANAYI VE TICARET ASInactiveASPIRIN 100% (U.S.P.).

DMF 62681986

EURAND AMERICA INCInactiveASPIRIN EC-2 (MICROENCAPSULATED)

DMF 80531989

BAYER AGInactiveASPIRIN USP

DMF 151492000

HEBEI JINGYE CHEMICAL CO LTDInactiveASPIRIN

DMF 225942008

HAINAN POLY PHARMACEUTICAL CO LTDInactiveASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES

DMF 237342010

JQC HUAYIN PHARMACEUTICAL CO LTDInactiveASPIRIN

DMF 298232015

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2022	SUPPL -9	View Letter (PDF)
Nov 17, 2021	SUPPL -8	View Letter (PDF)
Dec 12, 2019	SUPPL -4	View Letter (PDF)
Jul 26, 2018	SUPPL -3	View Letter (PDF)
Jan 16, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 325MG

RLD

4 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 14, 2013

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9216150	Sep 29, 2032	—	—	Yes	—	—
9226892	Sep 29, 2032	—	—	—		—
10646431	Sep 29, 2032	—	—	Yes	—	—
10786444	Sep 29, 2032	—	—	—		—

#002 — 81MG

RLD

2 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 26, 2021