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Phentolamine mesylate - Generic Drug Details
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What are the generic sources for phentolamine mesylate and what is the scope of patent protection?
Phentolamine mesylate
is the generic ingredient in three branded drugs marketed by Septodont Holding, Precision Dose Inc, West-ward Pharms Int, and Novartis, and is included in four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Phentolamine mesylate has thirty-four patent family members in twenty countries.
There are four drug master file entries for phentolamine mesylate. Four suppliers are listed for this compound.
Summary for phentolamine mesylate
| International Patents: | 34 |
| US Patents: | 5 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 4 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 85 |
| Clinical Trials: | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for phentolamine mesylate |
| DailyMed Link: | phentolamine mesylate at DailyMed |
Recent Clinical Trials for phentolamine mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Missouri-Columbia | Early Phase 1 |
| Ocuphire Pharma, Inc. | Phase 2 |
| AstraZeneca | Phase 1 |
Pharmacology for phentolamine mesylate
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for phentolamine mesylate
US Patents and Regulatory Information for phentolamine mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Septodont Holding | ORAVERSE | phentolamine mesylate | INJECTABLE;INJECTION | 022159-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Septodont Holding | ORAVERSE | phentolamine mesylate | INJECTABLE;INJECTION | 022159-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Precision Dose Inc | PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 207686-001 | Jul 14, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Septodont Holding | ORAVERSE | phentolamine mesylate | INJECTABLE;INJECTION | 022159-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | REGITINE | phentolamine mesylate | INJECTABLE;INJECTION | 008278-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Septodont Holding | ORAVERSE | phentolamine mesylate | INJECTABLE;INJECTION | 022159-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Septodont Holding | ORAVERSE | phentolamine mesylate | INJECTABLE;INJECTION | 022159-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 phentolamine mesylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2006225400 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0185171 | Start Trial |
| European Patent Office | 1280531 | Start Trial |
| Hong Kong | 1079444 | Start Trial |
| South Africa | 200410093 | Start Trial |
| Japan | 2010280702 | Start Trial |
| China | 1688312 | 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.
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