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Oxymetazoline hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for oxymetazoline hydrochloride?

Oxymetazoline hydrochloride is the generic ingredient in four branded drugs marketed by Johnson And Johnson, Allergan Inc, Bayer Healthcare Llc, and St Renatus, and is included in four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxymetazoline hydrochloride has nine patent family members in six countries.

There are three drug master file entries for oxymetazoline hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: oxymetazoline hydrochloride

Tradenames:4
Patents:7
Applicants:4
NDAs:4
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list34
Clinical Trials: see list996
Patent Applications: see list1,415
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxymetazoline hydrochloride at DailyMed

Pharmacology for Ingredient: oxymetazoline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
St Renatus
KOVANAZE
oxymetazoline hydrochloride; tetracaine hydrochloride
SPRAY, METERED;NASAL208032-001Jun 29, 2016RXYesYes8,580,282► SubscribeY ► Subscribe
Johnson And Johnson
VISINE L.R.
oxymetazoline hydrochloride
SOLUTION/DROPS;OPHTHALMIC019407-001Mar 31, 1989OTCYesYes► Subscribe► Subscribe
St Renatus
KOVANAZE
oxymetazoline hydrochloride; tetracaine hydrochloride
SPRAY, METERED;NASAL208032-001Jun 29, 2016RXYesYes6,413,499► Subscribe ► Subscribe
Bayer Healthcare Llc
OCUCLEAR
oxymetazoline hydrochloride
SOLUTION/DROPS;OPHTHALMIC018471-001May 30, 1986OTCNoNo► Subscribe► Subscribe
St Renatus
KOVANAZE
oxymetazoline hydrochloride; tetracaine hydrochloride
SPRAY, METERED;NASAL208032-001Jun 29, 2016RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: oxymetazoline hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,815,929Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists► Subscribe
8,877,793Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: oxymetazoline hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2012075319► Subscribe
Taiwan201242618► Subscribe
Australia2011336449► Subscribe
Japan6030067► Subscribe
TaiwanI533893► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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