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Last Updated: March 28, 2020

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Acetaminophen; aspirin; caffeine - Generic Drug Details

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What are the generic sources for acetaminophen; aspirin; caffeine and what is the scope of freedom to operate?

Acetaminophen; aspirin; caffeine is the generic ingredient in two branded drugs marketed by Perrigo and Glaxosmithkline Cons, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; aspirin; caffeine. Twenty-nine suppliers are listed for this compound.

Summary for acetaminophen; aspirin; caffeine
Recent Clinical Trials for acetaminophen; aspirin; caffeine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
BayerPhase 2
Ache Laboratorios Farmaceuticos S.A.Phase 3
BioHealthonomics Inc.Phase 2

See all acetaminophen; aspirin; caffeine clinical trials

Synonyms for acetaminophen; aspirin; caffeine
83535-74-4
Acetaminophen / aspirin / caffeine
Acetaminophen Mixture With Aspirin And Caffeine
acetaminophen, aspirin, caffeine drug combination
Acetyl Salicylic Acid Paracetamol Caffeine
Anadin Extra
Anfengapilin
APC-AC
BKMBGNWZSQNIKU-UHFFFAOYSA-N
C9H8O4.C8H10N4O2.C8H9NO2
Cibalena A
Dikalm
EXCEDRIN (MIGRAINE)
Excedrin extra strength
LS-178504
NeoCitramonum
Neuranidal
SCHEMBL4063268
Thomapyrin N
Paragraph IV (Patent) Challenges for ACETAMINOPHEN; ASPIRIN; CAFFEINE
Tradename Dosage Ingredient NDA Submissiondate
EXCEDRIN (MIGRAINE) TABLET;ORAL acetaminophen; aspirin; caffeine 020802

US Patents and Regulatory Information for acetaminophen; aspirin; caffeine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons EXCEDRIN (MIGRAINE) acetaminophen; aspirin; caffeine TABLET;ORAL 020802-001 Jan 14, 1998 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Perrigo ACETAMINOPHEN, ASPIRIN AND CAFFEINE acetaminophen; aspirin; caffeine TABLET;ORAL 075794-001 Nov 26, 2001 OTC No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for acetaminophen; aspirin; caffeine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons EXCEDRIN (MIGRAINE) acetaminophen; aspirin; caffeine TABLET;ORAL 020802-001 Jan 14, 1998   Start Trial   Start Trial
Glaxosmithkline Cons EXCEDRIN (MIGRAINE) acetaminophen; aspirin; caffeine TABLET;ORAL 020802-001 Jan 14, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Moodys
Harvard Business School
Mallinckrodt
AstraZeneca

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