ADVIL DUAL ACTION WITH ACETAMINOPHEN Drug Patent Profile
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Which patents cover Advil Dual Action With Acetaminophen, and when can generic versions of Advil Dual Action With Acetaminophen launch?
Advil Dual Action With Acetaminophen is a drug marketed by Haleon Us Holdings and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twelve patent family members in eleven countries.
The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Advil Dual Action With Acetaminophen
A generic version of ADVIL DUAL ACTION WITH ACETAMINOPHEN was approved as acetaminophen; ibuprofen by L PERRIGO CO on February 28th, 2023.
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Summary for ADVIL DUAL ACTION WITH ACETAMINOPHEN
| International Patents: | 12 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 86 |
| What excipients (inactive ingredients) are in ADVIL DUAL ACTION WITH ACETAMINOPHEN? | ADVIL DUAL ACTION WITH ACETAMINOPHEN excipients list |
| DailyMed Link: | ADVIL DUAL ACTION WITH ACETAMINOPHEN at DailyMed |
Recent Clinical Trials for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | Phase 4 |
| Wayne State University | N/A |
| Richard Dart, MD, PhD | Phase 2 |
See all ADVIL DUAL ACTION WITH ACETAMINOPHEN clinical trials
Pharmacology for ADVIL DUAL ACTION WITH ACETAMINOPHEN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for ADVIL DUAL ACTION WITH ACETAMINOPHEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | Tablets | acetaminophen; ibuprofen | 125 mg/250 mg | 211733 | 2 | 2024-03-28 |
US Patents and Regulatory Information for ADVIL DUAL ACTION WITH ACETAMINOPHEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733-001 | Feb 28, 2020 | OTC | Yes | Yes | ⤷ 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 |
International Patents for ADVIL DUAL ACTION WITH ACETAMINOPHEN
See the table below for patents covering ADVIL DUAL ACTION WITH ACETAMINOPHEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2024200875 | NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION | ⤷ Sign Up |
| Colombia | 2021017722 | Composición novedosa de ibuprofeno y acetaminofeno | ⤷ Sign Up |
| Mexico | 2021016089 | COMPOSICIÓN NOVEDOSA DE IBUPROFENO Y ACETAMINOFENO. (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION.) | ⤷ Sign Up |
| Canada | 3143724 | NOUVELLE COMPOSITION D'IBUPROFENE ET D'ACETAMINOPHENE (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION) | ⤷ Sign Up |
| European Patent Office | 3989944 | NOUVELLE COMPOSITION D'IBUPROFÈNE ET D'ACÉTAMINOPHÈNE (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION) | ⤷ 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.
ISSN: 2162-2639
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