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Acetaminophen - Generic Drug Details
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What are the generic sources for acetaminophen and what is the scope of patent protection?
Acetaminophen
is the generic ingredient in one hundred and five branded drugs marketed by Ortho Mcneil Pharm, Aurobindo Pharma Ltd, Custopharm Inc, Fresenius Kabi Usa, Mylan, Sandoz Inc, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Polymedica, J And J Consumer Inc, Granules, Heritage Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Glaxosmithkline Cons, Mikart, Scherer Labs, Kvk Tech Inc, Forest Pharms, Mallinckrodt, Granules Pharms, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Cnty Line Pharms, Halsey, Lgm Pharma, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Lannett Co Inc, Nuvo Pharms Inc, Wraser Pharms Llc, Us Chem, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Novast Labs, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Pharm Res Assoc, Leitner Pharms, Boca Pharma Llc, West-ward Pharm Corp, Novartis, Teva, Robins Ah, Solvay, Aci Healthcare Ltd, Actavis Mid Atlantic, Akorn, Anda Repository, Dava Pharms Inc, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Am Therap, Amneal Pharms Ny, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Kv Pharm, Lederle, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Alvogen Pine Brook, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Sun Pharm Inds Inc, Tris Pharma Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Actavis Elizabeth, Mikart Inc, Bristol Myers Squibb, Alvogen, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Rising, and Zydus Pharms Usa Inc, and is included in four hundred and ninety-six NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Acetaminophen has thirty-six patent family members in twenty-four countries.
There are sixty-six drug master file entries for acetaminophen. Sixty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for acetaminophen
| International Patents: | 36 |
| US Patents: | 24 |
| Tradenames: | 105 |
| Applicants: | 147 |
| NDAs: | 496 |
| Drug Master File Entries: | 66 |
| Suppliers / Packagers: | 69 |
| Bulk Api Vendors: | 146 |
| Clinical Trials: | 1,043 |
| Patent Applications: | 7,135 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for acetaminophen |
| Drug Sales Revenues: | Drug sales revenues for acetaminophen |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for acetaminophen |
| What excipients (inactive ingredients) are in acetaminophen? | acetaminophen excipients list |
| DailyMed Link: | acetaminophen at DailyMed |
Recent Clinical Trials for acetaminophen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laval University | Phase 3 |
| CHU de Quebec-Universite Laval | Phase 3 |
| Fraser Health | N/A |
Generic filers with tentative approvals for ACETAMINOPHEN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 325MG; 7.5MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for acetaminophen
Paragraph IV (Patent) Challenges for ACETAMINOPHEN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OFIRMEV | SOLUTION;INTRAVENOUS | acetaminophen | 022450 | 2011-04-07 |
| TYLENOL | TABLET, EXTENDED RELEASE;ORAL | acetaminophen | 019872 |
US Patents and Regulatory Information for acetaminophen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cerovene Inc | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 211690-001 | Feb 7, 2020 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Vintage Pharms | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040656-001 | Jan 19, 2006 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Nesher Pharms | OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 210079-003 | Dec 28, 2017 | AA | RX | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | Start Trial | Start Trial |
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | Start Trial | Start Trial |
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for acetaminophen
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| African Regional IP Organization (ARIPO) | 1880 | Start Trial |
| Hong Kong | 1166957 | Start Trial |
| Australia | 2010238854 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
