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-five patent family members in thirty countries.

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

Summary for OXYMETAZOLINE HYDROCHLORIDE

International Patents:	75
US Patents:	22
Tradenames:	6
Applicants:	6
NDAs:	6
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	51
Patent Applications:	3,217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYMETAZOLINE HYDROCHLORIDE
What excipients (inactive ingredients) are in OXYMETAZOLINE HYDROCHLORIDE?	OXYMETAZOLINE HYDROCHLORIDE excipients list
DailyMed Link:	OXYMETAZOLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OXYMETAZOLINE HYDROCHLORIDE

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
Rigshospitalet, Denmark	Phase 4
University of Alabama at Birmingham	Phase 4

See all OXYMETAZOLINE HYDROCHLORIDE clinical trials

Pharmacology for OXYMETAZOLINE HYDROCHLORIDE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Medical Subject Heading (MeSH) Categories for OXYMETAZOLINE HYDROCHLORIDE

Adrenergic alpha-Agonists
Nasal Decongestants
Sympathomimetics

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	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

Expired US Patents for OXYMETAZOLINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	⤷ Sign Up	⤷ Sign Up
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OXYMETAZOLINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Australia	2018229508	Pharmaceutical cream compositions comprising oxymetazoline	⤷ Sign Up
Japan	2014506927		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015191917		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012118704		⤷ Sign Up
>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.