NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Naproxen Sodium And Pseudoephedrine Hydrochloride, and what generic alternatives are available?
Naproxen Sodium And Pseudoephedrine Hydrochloride is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo. and is included in three NDAs.
The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naproxen Sodium And Pseudoephedrine Hydrochloride
A generic version of NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17th, 2004.
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Summary for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 9 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Reddy's Laboratories Limited | Phase 1 |
See all NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials
Pharmacology for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
| Drug Class | Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211360-001 | Jun 1, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Inc | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077381-001 | Sep 27, 2006 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076518-001 | Mar 17, 2004 | OTC | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
