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Last Updated: September 18, 2020

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Oxymetazoline hydrochloride - Generic Drug Details

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What are the generic sources for oxymetazoline hydrochloride and what is the scope of patent protection?

Oxymetazoline hydrochloride is the generic ingredient in five branded drugs marketed by Epi Hlth, Bayer Healthcare Llc, Rvl Pharms, Johnson And Johnson, and St Renatus, and is included in five NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxymetazoline hydrochloride has forty-eight patent family members in twenty-four countries.

There are three drug master file entries for oxymetazoline hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for oxymetazoline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Maryland, BaltimoreN/A
Teva Pharmaceuticals USAPhase 3
Actavis Inc.Phase 3

See all oxymetazoline hydrochloride clinical trials

Pharmacology for oxymetazoline hydrochloride
Medical Subject Heading (MeSH) Categories for oxymetazoline hydrochloride
Paragraph IV (Patent) Challenges for OXYMETAZOLINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
RHOFADE CREAM;TOPICAL oxymetazoline hydrochloride 208552 2019-06-20

US Patents and Regulatory Information for oxymetazoline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Johnson And Johnson VISINE L.R. oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 019407-001 Mar 31, 1989 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
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Moodys

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