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 two Paragraph IV challenges.
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-six 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.
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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: | 3,399 |
| 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 five US patents.
Patents protecting ofirmev
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Mexico | PA03000001 | NUEVO METODO PARA OBTENER FORMULACIONES ACUOSAS CON PRINCIPIOS ACTIVOS SUSCEPTIBLES A OXIDACION Y LAS SOLUCIONES ACUOSAS OBTENIDAS DE ESTE MODO. (METHOD FOR OBTAINING AQUEOUS FORMULATIONS OF OXIDATION-SENSITIVE ACTIVE PRINCIPLES.) | ⤷ Sign Up |
| European Patent Office | 0858329 | NOUVELLES FORMULATIONS LIQUIDES STABLES A BASE DE PARACETAMOL ET LEUR MODE DE PREPARATION (NOVEL STABLE LIQUID PARACETAMOL COMPOSITIONS, AND METHOD FOR PREPARING SAME) | ⤷ Sign Up |
| New Zealand | 523458 | New method for obtaining aqueous formulations with active principles susceptible to oxidation and the aqueous solutions thus obtained | ⤷ Sign Up |
| 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) | ⤷ Sign Up |
| Japan | 5909750 | ⤷ Sign Up | |
| Australia | 6612001 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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