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Serving leading biopharmaceutical companies globally:

Colorcon
Cerilliant
Mallinckrodt
Covington
Chubb
Queensland Health
Chinese Patent Office
QuintilesIMS
Accenture
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Generated: October 19, 2017

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Phenylephrine hydrochloride - Generic Drug Details

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What are the generic sources for phenylephrine hydrochloride and what is the scope of phenylephrine hydrochloride patent protection?

Phenylephrine hydrochloride
is the generic ingredient in nine branded drugs marketed by Avadel Legacy, Paragon Bioteck, Akorn Inc, West Ward Pharm Corp, Amneal Pharms, Ani Pharms, Cenci, Vintage, G And W Labs Inc, Halsey, Hi-tech Pharmacal, Wockhardt, and Allergan, and is included in thirteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenylephrine hydrochloride has one patent family member in one country and two supplementary protection certificates in two countries.

There are twenty drug master file entries for phenylephrine hydrochloride. Six suppliers are listed for this compound.

Summary for Generic Name: phenylephrine hydrochloride

US Patents:1
Tradenames:9
Applicants:13
NDAs:13
Drug Master File Entries: see list20
Suppliers / Packagers: see list6
Bulk Api Vendors: see list28
Clinical Trials: see list2,447
Patent Applications: see list2,103
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:phenylephrine hydrochloride at DailyMed

Pharmacology for Ingredient: phenylephrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avadel Legacy
VAZCULEP
phenylephrine hydrochloride
SOLUTION;IV (INFUSION)204300-003Jun 27, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Amneal Pharms
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL040902-001Aug 25, 2009AARXNoNo► Subscribe► Subscribe► Subscribe
Paragon Bioteck
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203510-002Mar 21, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Vintage
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL040654-001Dec 7, 2006AARXNoNo► Subscribe► Subscribe► Subscribe
Halsey
PHERAZINE VC
phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL088868-001Mar 2, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Paragon Bioteck
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203510-001Mar 21, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Avadel Legacy
VAZCULEP
phenylephrine hydrochloride
SOLUTION;IV (INFUSION)204300-002Jun 27, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Ani Pharms
PHENERGAN VC
phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL008604-003Apr 2, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Hi-tech Pharmacal
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL040675-001Dec 23, 2014AARXNoNo► Subscribe► Subscribe► Subscribe
Akorn Inc
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride
SOLUTION/DROPS;OPHTHALMIC207926-001Jan 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: phenylephrine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2015073696► 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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Supplementary Protection Certificates for Tradename: PHENYLEPHRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0090France► SubscribePRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
923Luxembourg► SubscribePRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
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Serving leading biopharmaceutical companies globally:

McKinsey
US Army
Cipla
UBS
Harvard Business School
Daiichi Sankyo
McKesson
Baxter
Covington
Dow

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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