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8-HOUR BAYER

NDA

ASPIRIN | N016030 | BAYER HEALTHCARE 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 3 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension NCT05056896	Early Phase 1	Active	Massachusetts General Hospital	161	2022-06-03 → 2026-12-31
Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease NCT07658807	Phase 3	Not Yet Recruiting	Xuanwu Hospital, Beijing	300	2026-06 → 2029-01
Optimizing the Use of Aspirin for the Prevention of Preeclampsia NCT07665853	Phase 3	Not Yet Recruiting	Hospital Universitari Vall d'Hebron Research Institute	15,160	2026-07-01 → 2028-05
Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis NCT07673185	N/A	Recruiting	Al-Azhar University	40	2025-01-15 → 2026-10-30
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)NCT03121209	Phase 3	Completed	Columbia University	392	2018-01-18 → 2025-07-31

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

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.

Products (2)

Sort:

#001 — 650MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 650MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982