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Last Updated: November 4, 2024

DELSYM Drug Patent Profile


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When do Delsym patents expire, and when can generic versions of Delsym launch?

Delsym is a drug marketed by Rb Hlth and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Delsym

A generic version of DELSYM was approved as dextromethorphan polistirex by TRIS PHARMA INC on May 25th, 2012.

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Summary for DELSYM
Drug patent expirations by year for DELSYM
Drug Prices for DELSYM

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Drug Sales Revenue Trends for DELSYM

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Recent Clinical Trials for DELSYM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Southern CaliforniaPhase 4
TakedaPhase 4
The Johns Hopkins Institute for Clinical and Translational Research (ICTR)Phase 2

See all DELSYM clinical trials

Paragraph IV (Patent) Challenges for DELSYM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DELSYM Extended-release Suspension dextromethorphan polistirex 30 mg/5 mL 018658 1 2009-01-12

US Patents and Regulatory Information for DELSYM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DELSYM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 ⤷  Sign Up ⤷  Sign Up
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DELSYM

See the table below for patents covering DELSYM around the world.

Country Patent Number Title Estimated Expiration
Canada 2234282 COMPLEXES MEDICAMENT/RESINE STABILISES PAR DES CHELATEURS (DRUG-RESIN COMPLEXES STABILIZED BY CHELATING AGENTS) ⤷  Sign Up
European Patent Office 0911039 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DELSYM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 122013000090 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166 CR 2013 00059 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166 2013/055 Ireland ⤷  Sign Up PRODUCT 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
1539166 13C0062 France ⤷  Sign Up PRODUCT 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 EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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