OFIRMEV Drug Patent Profile
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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 one Paragraph IV challenge.
This drug has four patent family members in three countries.
The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety 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.
Summary for OFIRMEV
| International Patents: | 4 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 179 |
| Clinical Trials: | 60 |
| Patent Applications: | 5,828 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| National Institute on Aging (NIA) | Phase 3 |
| Beth Israel Deaconess Medical Center | Phase 3 |
| Lotus Clinical Research, LLC | Phase 2 |
Paragraph IV (Patent) Challenges for OFIRMEV
| 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 OFIRMEV
OFIRMEV is protected by five US patents.
Patents protecting OFIRMEV
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Reduced dose intravenous acetaminophen
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
Expired US Patents for OFIRMEV
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OFIRMEV
See the table below for patents covering OFIRMEV around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2233924 | NOUVELLES FORMULATIONS LIQUIDES STABLES A BASE DE PARACETAMOL ET LEUR MODE DE PREPARATION (NOVEL STABLE LIQUID PARACETAMOL COMPOSITIONS, AND METHOD FOR PREPARING SAME) | ⤷ Try a Trial |
| Mexico | 9802734 | NUEVAS FORMULACIONES LIQUIDAS ESTABLES A BASE DE PARACETAMOL Y SU MODO DE PREPARACION. (NOVEL STABLE LIQUID PARACETAMOL COMPOSITIONS, AND METHOD FOR PREPARING SAME.) | ⤷ Try a Trial |
| Australia | 6612001 | ⤷ Try a 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. 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
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