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Last Updated: April 18, 2024

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 six branded drugs marketed by Taro, Mayne Pharma, Bayer Healthcare Llc, Rvl Pharms, Johnson And Johnson, and St Renatus, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxymetazoline hydrochloride has seventy-three patent family members in thirty countries.

There is one drug master file entry for oxymetazoline hydrochloride. Three suppliers are listed for this compound.

Recent Clinical Trials for OXYMETAZOLINE HYDROCHLORIDE

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

SponsorPhase
Rigshospitalet, DenmarkPhase 4
University of Alabama at BirminghamPhase 4
University of South FloridaPhase 4

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 Strength NDA ANDAs Submitted Submissiondate
RHOFADE Topical Cream oxymetazoline hydrochloride 1% 208552 1 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
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Taro OXYMETAZOLINE HYDROCHLORIDE oxymetazoline hydrochloride CREAM;TOPICAL 213584-001 Oct 4, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for OXYMETAZOLINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Spain 2796871 ⤷  Try a Trial
Morocco 55895 COMPOSITIONS D'OXYMÉTAZOLINE ET PROCÉDÉS DE TRAITEMENT DE TROUBLES OCULAIRES ⤷  Try a Trial
Peru 20220384 COMPOSICIONES Y METODOS DE OXIMETAZOLINA PARA EL TRATAMIENTO DE TRASTORNOS OCULARES ⤷  Try a Trial
European Patent Office 2680829 COMPOSITIONS ET UTILISATIONS POUR LE TRAITEMENT NON-CHIRURGICAL DE LA PTOSIS (COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.