Acetaminophen; naproxen sodium - Generic Drug Details
What are the generic sources for acetaminophen; naproxen sodium and what is the scope of patent protection?
Acetaminophen; naproxen sodium
is the generic ingredient in one branded drug marketed by Kenvue Brands and is included in one NDA. Additional information is available in the individual branded drug profile pages.DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for acetaminophen; naproxen sodium
Generic Entry Date for acetaminophen; naproxen sodium*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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 acetaminophen; naproxen sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johnson & Johnson Consumer Inc. (J&JCI) | Phase 1 |
| Johnson & Johnson Consumer Inc. (J&JCI) | Phase 3 |
| Ciusss de L'Est de l'Île de Montréal | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; naproxen sodium
US Patents and Regulatory Information for acetaminophen; naproxen sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kenvue Brands | TYLENOL WITH NAPROXEN | acetaminophen; naproxen sodium | TABLET;ORAL | 219962-001 | Jul 24, 2026 | OTC | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
