OFIRMEV Drug Patent Profile
✉ Email this page to a colleague
When do Ofirmev patents expire, and what generic alternatives are available?
Ofirmev is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in OFIRMEV is acetaminophen. There is one drug master file entry for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ofirmev
A generic version of OFIRMEV was approved as acetaminophen by PERRIGO on February 25th, 2000.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for OFIRMEV?
- What are the global sales for OFIRMEV?
- What is Average Wholesale Price for OFIRMEV?
Summary for OFIRMEV
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 179 |
| Clinical Trials: | 60 |
| Patent Applications: | 3,930 |
| Drug Prices: | Drug price information for OFIRMEV |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OFIRMEV |
| What excipients (inactive ingredients) are in OFIRMEV? | OFIRMEV excipients list |
| DailyMed Link: | OFIRMEV at DailyMed |
Recent Clinical Trials for OFIRMEV
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beth Israel Deaconess Medical Center | Phase 3 |
| National Institute on Aging (NIA) | Phase 3 |
| Nevakar, Inc. | Phase 2 |
Paragraph IV (Patent) Challenges for OFIRMEV
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OFIRMEV | Injection | acetaminophen | 650 mg/65 mL (10 mg/mL) | 022450 | 1 | 2024-07-31 |
| OFIRMEV | Injection | acetaminophen | 1000 mg/100 mL (10 mg/mL) | 022450 | 1 | 2011-04-07 |
US Patents and Regulatory Information for OFIRMEV
OFIRMEV is protected by four US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start 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 OFIRMEV
See the table below for patents covering OFIRMEV around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2705733 | ACETAMINOPHENE PAR VOIE INTRAVEINEUSE EN DOSE REDUITE (REDUCED DOSE INTRAVENOUS ACETAMINOPHEN) | ⤷ Start Trial |
| Japan | 2011503198 | 低用量静脈内アセトアミノフェン | ⤷ Start Trial |
| Japan | 5909750 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2009064928 | ⤷ Start Trial | |
| African Regional IP Organization (ARIPO) | 957 | Novel stable liquid paracetamol compositions, and method for preparing same. | ⤷ Start Trial |
| African Regional IP Organization (ARIPO) | 9801223 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch