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Acetaminophen is a drug marketed by Custopharm Inc, Fresenius Kabi Usa, Sandoz Inc, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Aurobindo Pharma Ltd, Granules India Ltd, Heritage Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and twenty-two NDAs. There is one patent protecting this drug.
This drug has seventeen patent family members in twelve countries.
The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Annual sales in 2017 were $7mm indicating the motivation for generic entry (peak sales were $30mm in 2005).
There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ACETAMINOPHEN
|Suppliers / Packagers:||59|
|Bulk Api Vendors:||137|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for ACETAMINOPHEN|
|Drug Sales Revenues:||Drug sales revenues for ACETAMINOPHEN|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for ACETAMINOPHEN|
|DailyMed Link:||ACETAMINOPHEN at DailyMed|
Recent Clinical Trials for ACETAMINOPHEN
Identify potential brand extensions & 505(b)(2) entrants
|Scilex Pharmaceuticals, Inc.||N/A|
|Washington D.C. Veterans Affairs Medical Center||N/A|
|Pain Management Institute Bethesda-Washington-Maryland||N/A|
|Country||Patent Number||Estimated Expiration|
|Hong Kong||1166957||Start Trial|
|European Patent Office||2243477||Start Trial|
|European Patent Office||2626068||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|