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Covington
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Generated: December 14, 2017

DrugPatentWatch Database Preview

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 Akorn Inc, Paragon Bioteck, West Ward Pharm Corp, Avadel Legacy, Ani Pharms, Hi-tech Pharmacal, Vintage, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, 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.

Pharmacology for phenylephrine hydrochloride

Medical Subject Heading (MeSH) Categories for phenylephrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
HalseyPHERAZINE VCphenylephrine hydrochloride; promethazine hydrochlorideSYRUP;ORAL088868-001Mar 2, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AllerganPREFRIN-Aphenylephrine hydrochloride; pyrilamine maleateSOLUTION/DROPS;OPHTHALMIC007953-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
G And W Labs IncPROMETH VC PLAINphenylephrine hydrochloride; promethazine hydrochlorideSYRUP;ORAL088761-001Nov 8, 1984AARXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Paragon BioteckPHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochlorideSOLUTION/DROPS;OPHTHALMIC203510-001Mar 21, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Paragon BioteckPHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochlorideSOLUTION/DROPS;OPHTHALMIC203510-002Mar 21, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Avadel LegacyVAZCULEPphenylephrine hydrochlorideSOLUTION;IV (INFUSION)204300-003Jun 27, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
WockhardtPROMETHAZINE VC PLAINphenylephrine hydrochloride; promethazine hydrochlorideSYRUP;ORAL088897-001Jan 4, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Avadel LegacyVAZCULEPphenylephrine hydrochlorideSOLUTION;IV (INFUSION)204300-002Jun 27, 2014RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
West Ward Pharm CorpPHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochlorideSOLUTION;IV (INFUSION)203826-001Dec 20, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Avadel LegacyVAZCULEPphenylephrine hydrochlorideSOLUTION;IV (INFUSION)204300-001Jun 27, 2014RXYesNo► Subscribe► 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:

UBS
Queensland Health
Moodys
US Department of Justice
Farmers Insurance
Chubb
Medtronic
Novartis
Argus Health
Mallinckrodt

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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