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-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
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Johnson And Johnson	VISINE L.R.	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019407-001	Mar 31, 1989		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
Cyprus	1122565		⤷ Sign Up
South Korea	101889392		⤷ Sign Up
Australia	2020268329	Oxymetazoline compositions and methods for treating ocular disorders	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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