ADVIL DUAL ACTION WITH ACETAMINOPHEN Drug Patent Profile
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Which patents cover Advil Dual Action With Acetaminophen, and what generic alternatives are available?
Advil Dual Action With Acetaminophen is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for ADVIL DUAL ACTION WITH ACETAMINOPHEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 82 |
| Formulation / Manufacturing: | see details |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Generic Entry Date for ADVIL DUAL ACTION WITH ACETAMINOPHEN*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wayne State University | N/A |
| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Phase 2 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ADVIL DUAL ACTION WITH ACETAMINOPHEN
US Patents and Regulatory Information for ADVIL DUAL ACTION WITH ACETAMINOPHEN
ADVIL DUAL ACTION WITH ACETAMINOPHEN is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADVIL DUAL ACTION WITH ACETAMINOPHEN is See Plans and Pricing.
This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting ADVIL DUAL ACTION WITH ACETAMINOPHEN
NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733-001 | Feb 28, 2020 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
