NAPHAZOLINE HYDROCHLORIDE Drug Patent Profile
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When do Naphazoline Hydrochloride patents expire, and what generic alternatives are available?
Naphazoline Hydrochloride is a drug marketed by Rising and Altaire Pharms Inc and is included in three NDAs.
The generic ingredient in NAPHAZOLINE HYDROCHLORIDE is naphazoline hydrochloride; pheniramine maleate. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naphazoline Hydrochloride
A generic version of NAPHAZOLINE HYDROCHLORIDE was approved as naphazoline hydrochloride; pheniramine maleate by ALTAIRE PHARMS INC on September 27th, 2010.
Summary for NAPHAZOLINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,152 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NAPHAZOLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NAPHAZOLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Sophia S.A de C.V. | Phase 1 |
| Sanofi | Phase 1 |
| EMS | Phase 3 |
Medical Subject Heading (MeSH) Categories for NAPHAZOLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for NAPHAZOLINE HYDROCHLORIDE
US Patents and Regulatory Information for NAPHAZOLINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | NAPHAZOLINE HYDROCHLORIDE | naphazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 083590-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Altaire Pharms Inc | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 078208-001 | Sep 27, 2010 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rising | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 202795-001 | Jan 24, 2013 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
