NAPHAZOLINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for naphazoline hydrochloride and what is the scope of freedom to operate?
Naphazoline hydrochloride
is the generic ingredient in ten branded drugs marketed by Allergan, Bausch And Lomb, Pharmafair, Rising, Alcon, Novartis, Altaire Pharms Inc, and Johnson And Johnson, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for naphazoline hydrochloride.
Summary for NAPHAZOLINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 10 |
| Applicants: | 8 |
| NDAs: | 12 |
| Drug Master File Entries: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,927 |
| What excipients (inactive ingredients) are in NAPHAZOLINE HYDROCHLORIDE? | NAPHAZOLINE HYDROCHLORIDE excipients list |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb | OPCON-A | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 020065-001 | Jun 8, 1994 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | NAPHAZOLINE HYDROCHLORIDE | naphazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 083590-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 202795-001 | Jan 24, 2013 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb | OPCON | naphazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 087506-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb | NAFAZAIR | naphazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 040073-001 | May 25, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Johnson And Johnson | VISINE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 020485-001 | Jan 31, 1996 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alcon | NAPHCON-A | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 020226-001 | Jun 8, 1994 | OTC | Yes | 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 |
