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Dextromethorphan polistirex - Generic Drug Details

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Dextromethorphan polistirex is the generic ingredient in two branded drugs marketed by Tris Pharma Inc and Reckitt Benckiser, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two patent family members in two countries.

There are twenty-two drug master file entries for dextromethorphan polistirex. Thirty-eight suppliers are listed for this compound.

Summary for Generic Name: dextromethorphan polistirex

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list22
Suppliers / Packaging: see list38
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 1982OTCYes5,980,882► subscribeY ► subscribe
Tris Pharma Inc
DEXTROMETHORPHAN POLISTIREX
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL091135-001May 25, 2012OTCNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: dextromethorphan polistirex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 19824,221,778► subscribe
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International Patent Family for Ingredient: dextromethorphan polistirex

Country Document Number Estimated Expiration
Canada2234282► subscribe
European Patent Office0911039► 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: DEXTROMETHORPHAN POLISTIREX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0062France► subscribePRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE ET EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
323Luxembourg► subscribePRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
13/055Ireland► subscribePRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
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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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