ACETAMINOPHEN Drug Patent Profile
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When do Acetaminophen patents expire, and what generic alternatives are available?
Acetaminophen is a drug marketed by Rising, Aspiro, B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Able, Acino Prods, Perrigo New York, Taro, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Strides Pharma, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Bionpharma, L Perrigo Co, Gavis Pharms, Aurobindo Pharma Ltd, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and thirty-seven 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. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
DrugPatentWatch® Generic Entry Outlook for Acetaminophen
There have been fourteen 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
International Patents: | 17 |
US Patents: | 1 |
Applicants: | 68 |
NDAs: | 137 |
Finished Product Suppliers / Packagers: | 91 |
Raw Ingredient (Bulk) Api Vendors: | 178 |
Clinical Trials: | 1,281 |
Patent Applications: | 5,220 |
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 |
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 Hospital "Sestre Milosrdnice" | N/A |
University of Sao Paulo General Hospital | N/A |
Johnson & Johnson Consumer Inc. (J&JCI) | Phase 1 |
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
ACETAMINOPHEN is protected by one US patents.
Patents protecting ACETAMINOPHEN
Paracetamol for parenteral administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Halsey | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 083872-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roxane | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 089513-001 | Apr 25, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dava Pharms Inc | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | SOLUTION;ORAL | 040098-001 | Sep 20, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ACETAMINOPHEN
See the table below for patents covering ACETAMINOPHEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 2626068 | ⤷ Try a Trial | |
China | 102421426 | Paracetamol for parenteral administration | ⤷ Try a Trial |
Portugal | 2421522 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |