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 25^th, 2012.

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Summary for DELSYM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	5
Patent Applications:	1,260
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DELSYM
What excipients (inactive ingredients) are in DELSYM?	DELSYM excipients list
DailyMed Link:	DELSYM at DailyMed

Drug patent expirations by year for DELSYM

Recent Clinical Trials for DELSYM

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

Sponsor	Phase
University of Southern California	Phase 4
Takeda	Phase 4
The Johns Hopkins Institute for Clinical and Translational Research (ICTR)	Phase 2

See all DELSYM clinical trials

Pharmacology for DELSYM

Drug Class	Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

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

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Glossary

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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

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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.

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

Supplementary Protection Certificates for DELSYM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 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	92323	Luxembourg	⤷ Sign Up	PRODUCT 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
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	60/2013	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description