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Last Updated: January 30, 2023

Oxymetazoline hydrochloride - Generic Drug Details


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What are the generic drug sources for oxymetazoline hydrochloride and what is the scope of freedom to operate?

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

Oxymetazoline hydrochloride has sixty-nine 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
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Taro Pharms OXYMETAZOLINE HYDROCHLORIDE oxymetazoline hydrochloride CREAM;TOPICAL 213584-001 Oct 4, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Denmark 2680829 See Plans and Pricing
South Korea 20140013013 COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS See Plans and Pricing
Colombia 2021015265 Composiciones y m├ętodos de oximetazolina para el tratamiento de trastornos oculares See Plans and Pricing
South Korea 102410503 See Plans and Pricing
Japan 2014506927 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2012075319 See Plans and Pricing
Singapore 192801 COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Express Scripts
Dow
Merck
Medtronic

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.