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Generated: June 25, 2017
What are the generic drug sources for acetaminophen and what is the scope of acetaminophen patent protection?
Acetaminophen is the generic ingredient in one hundred and four branded drugs marketed by Ohm Labs, Polymedica, Custopharm Inc, Sun Pharm Inds Ltd, Able, Perrigo New York, Roxane, G And W Labs, Aurobindo Pharma Ltd, Taro Pharms North, Mallinckrodt Ip, Sandoz Inc, J And J Consumer Inc, Fresenius Kabi Usa, Perrigo, Ortho Mcneil Pharm, Glaxosmithkline Cons, Scherer Labs, Mikart, Mallinckrodt, Valeant, Cnty Line Pharms, Tedor Pharma Inc, Mayrand, Watson Labs, Nexgen Pharma, Dunhall, Halsey, Larken Labs Inc, Mikart Inc, Forest Pharms, Sun Pharm Inds, Mallinckrodt Inc, Mayne Pharma Inc, Vintage Pharms, Us Chem, Actavis Labs Ut Inc, Nuvo Pharm Inc, Hikma Pharms Llc, Gilbert Labs, Shire, Graham Dm, Lannett Holdings Inc, Ingenus Pharms Nj, Mirror Pharms Llc, Hikma Intl Pharms, Nexgen Pharma Inc, Boca Pharma Llc, West-ward Pharm Corp, Leitner Pharms, Pharm Res Assoc, Wraser Pharms Llc, Novartis, Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Vangard, Everylife, Sandoz, Hi Tech Pharma, Usl Pharma, Duramed Pharms Barr, Teva, Valeant Pharms Llc, Lederle, Watson Labs Florida, Carnrick, Robins Ah, Glaxosmithkline, Mutual Pharm, Superpharm, Janssen Pharms, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Frontida Biopharm, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Solvay, Valeant Pharm Intl, Dava Pharms Inc, Schering Plough, Ucb Inc, Par Pharm, Ivax Pharms, Barr, Tris Pharma Inc, Abbvie, Sun Pharm Inds Inc, Ranbaxy Labs Ltd, Ranbaxy, Amneal Pharms, Novel Labs Inc, Vistapharm, Apil, Cent Pharms, Caraco, Nesher Pharms, Abbott, Cypress Pharm Inc, Actavis Labs Fl Inc, Abana, Ascher, Vintage Pharms Llc, Upsher-smith Labs, Rhodes Pharms, Actavis Elizabeth, West-ward Pharms Int, Bristol Myers Squibb, Ascent Pharms Inc, Cerovene Inc, Alvogen Malta, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Mylan, Mirror Pharms, Xanodyne Pharm, Cornerstone, Mylan Pharms Inc, Ivax Sub Teva Pharms, Wockhardt Ltd, Micro Labs Ltd India, Zydus Pharms Usa Inc, Atlas Pharms Llc, Apotex Inc, and Macleods Pharms Ltd, and is included in four hundred and forty-nine NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 104 |
| Patents: | 19 |
| Applicants: | 132 |
| NDAs: | 449 |
| Drug Master File Entries: see list | 65 |
| Suppliers / Packagers: see list | 69 |
| Bulk Api Vendors: see list | 108 |
| Clinical Trials: see list | 702 |
| Patent Applications: see list | 9,698 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | acetaminophen at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
West-ward Pharms Int | ROXICET | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 087003-001 | Approved Prior to Jan 1, 1982 | AA | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cerovene Inc | OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 207574-001 | Dec 13, 2016 | AA | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Watson Labs | OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | CAPSULE;ORAL | 040234-001 | Oct 30, 1997 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Mirror Pharms Llc | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | TABLET;ORAL | 040883-001 | Dec 23, 2008 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Purepac Pharm | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 086683-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | 4,820,522 | ► Subscribe | ||||||||||||||||||||||
J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | 5,004,613 | ► Subscribe | ||||||||||||||||||||||
J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | 4,968,509 | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mexico | PA03000001 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0858329 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2201316 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2009064928 | ► Subscribe | |||||||||||||||||||||||||||
| African Regional IP Organization (ARIPO) | 200202711 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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