Acetaminophen - Generic Drug Details
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What are the generic drug sources for acetaminophen and what is the scope of freedom to operate?
Acetaminophen
is the generic ingredient in one hundred and five branded drugs marketed by Ortho Mcneil Pharm, Rising, B Braun Medical Inc, Baxter Hlthcare Corp, Custopharm Inc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan, Sandoz Inc, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Polymedica, J And J Consumer Inc, Aurobindo Pharma Ltd, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Glaxosmithkline Cons, Mikart, Scherer Labs, Kvk Tech Inc, Forest Pharms, Mallinckrodt, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Lannett Co Inc, Nuvo Pharms Inc, Riconpharma Llc, Xspire Pharma, Us Chem, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Nostrum Labs Inc, Wraser Pharms Llc, Pharm Res Assoc, Leitner Pharms, Boca Pharma Llc, West-ward Pharm Corp, Novartis, Teva, Robins Ah, Solvay, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, 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, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Tris Pharma Inc, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, Anda Repository, Apil, Ascent Pharms Inc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Sun Pharm Inds Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Actavis Elizabeth, Bristol Myers Squibb, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, and Zydus Pharms Usa Inc, and is included in five hundred and nine NDAs. There are twenty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Acetaminophen has twenty-one patent family members in thirteen countries.
There are sixty-six drug master file entries for acetaminophen. Eighty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for acetaminophen
International Patents: | 21 |
US Patents: | 22 |
Tradenames: | 105 |
Applicants: | 151 |
NDAs: | 509 |
Drug Master File Entries: | 66 |
Finished Product Suppliers / Packagers: | 84 |
Raw Ingredient (Bulk) Api Vendors: | 160 |
Clinical Trials: | 1,214 |
Patent Applications: | 6,395 |
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 |
---|---|
University of Sao Paulo General Hospital | N/A |
Gustavo Avila-Ortiz DDS, MS, PhD | Phase 4 |
Osteology Foundation | Phase 4 |
Generic filers with tentative approvals for ACETAMINOPHEN
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OFIRMEV | Injection | acetaminophen | 1000 mg/100 mL (10 mg/mL) | 022450 | 1 | 2011-04-07 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 215135-002 | Mar 25, 2022 | AA | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Scherer Labs | CODEINE, ASPIRIN, APAP FORMULA NO. 2 | acetaminophen; aspirin; codeine phosphate | CAPSULE;ORAL | 085640-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Vintage Pharms Llc | ZYDONE | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040288-001 | Nov 27, 1998 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | See Plans and Pricing | See Plans and Pricing |
Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | See Plans and Pricing | See Plans and Pricing |
J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for acetaminophen
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2564547 | See Plans and Pricing | |
Japan | 5909750 | See Plans and Pricing | |
Brazil | PI1011630 | paracetamol para a administração parenteral | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |