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.
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: | 1,267 |
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 |
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 |
Pharmacology for DELSYM
Anatomical Therapeutic Chemical (ATC) Classes for DELSYM
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Rb Hlth | DELSYM | dextromethorphan polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 018658-001 | Oct 8, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
European Patent Office | 0911039 | ⤷ Try a Trial | |
Canada | 2234282 | COMPLEXES MEDICAMENT/RESINE STABILISES PAR DES CHELATEURS (DRUG-RESIN COMPLEXES STABILIZED BY CHELATING AGENTS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DELSYM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1539166 | 92323 | Luxembourg | ⤷ Try a Trial | 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 | CR 2013 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
1539166 | 122013000090 | Germany | ⤷ Try a Trial | 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 | 2013C/064 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626 |
1539166 | 60/2013 | Austria | ⤷ Try a Trial | 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 |