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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 five branded drugs marketed by Epi Hlth, Bayer Healthcare Llc, Rvl Pharms, Johnson And Johnson, and St Renatus, and is included in five NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Oxymetazoline hydrochloride has fifty-three patent family members in twenty-four countries.
There are three drug master file entries for oxymetazoline hydrochloride. One supplier is listed for this compound.
Summary for OXYMETAZOLINE HYDROCHLORIDE
| International Patents: | 53 |
| US Patents: | 14 |
| Tradenames: | 5 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 40 |
| Patent Applications: | 1,659 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Sorlandet Hospital HF | Phase 4 |
| Kfir Siag | Early Phase 1 |
| University of Maryland, Baltimore | N/A |
Pharmacology for OXYMETAZOLINE HYDROCHLORIDE
| Drug Class | Vasoconstrictor |
| Physiological Effect | Vasoconstriction Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for OXYMETAZOLINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for OXYMETAZOLINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RHOFADE | CREAM;TOPICAL | oxymetazoline hydrochloride | 208552 | 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 | Start Trial | Start Trial | Start Trial | ||||
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Epi Hlth | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Epi Hlth | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Healthcare Llc | OCUCLEAR | oxymetazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 018471-001 | May 30, 1986 | DISCN | No | No | Start Trial | Start Trial | Start 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 | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012075319 | Start Trial |
| Russian Federation | 2582392 | Start Trial |
| Australia | 2018229508 | Start Trial |
| Poland | 2645993 | Start Trial |
| Australia | 2015274532 | Start Trial |
| >Country | >Patent Number | >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.
ISSN: 2162-2639
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