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Last Updated: February 28, 2024

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, 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
Rvl Pharms UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520-001 Jul 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  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 ⤷  Try a Trial
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc OCUCLEAR oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 018471-001 May 30, 1986 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 ⤷  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
Japan 6106100 ⤷  Try a Trial
Serbia 59636 KOMPOZICIJE I POSTUPCI ZA NEHIRURŠKO LEČENJE PTOZE (COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS) ⤷  Try a Trial
Australia 2011336449 Pharmaceutical cream compositions comprising oxymetazoline ⤷  Try a Trial
Taiwan 201242618 Pharmaceutical cream compositions and methods of use ⤷  Try a Trial
Mexico 2013009597 COMPOSICIONES Y METODOS PARA TRATAMIENTO NO QUIRURGICO DE PTOSIS. (COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS.) ⤷  Try a Trial
China 103501771 Compositions and methods for non-surgical treatment of ptosis ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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