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DELSYM Drug Profile

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Delsym is a drug marketed by Reckitt Benckiser and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in DELSYM is dextromethorphan polistirex. There are twenty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.

Summary for Tradename: DELSYM

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list7
Bulk Api Vendors: see list17
Clinical Trials: see list5
Formulation / Manufacturing:see details
Drug Prices:see details
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
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Expired Patents for Tradename: DELSYM

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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Paragraph IV activity for: DELSYM

Drugname Dosage Strength RLD Submissiondate
dextromethorphan polistirexExtended-release Suspension30 mg/5 mLDelsym1/12/2009

International Patent Family for Tradename: DELSYM

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00059Denmark► subscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
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
2013 00059Denmark► subscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. 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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