Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Dexbrompheniramine maleate; pseudoephedrine sulfate - Generic Drug Details

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What are the generic drug sources for dexbrompheniramine maleate; pseudoephedrine sulfate and what is the scope of patent protection?

Dexbrompheniramine maleate; pseudoephedrine sulfate is the generic ingredient in six branded drugs marketed by Copley Pharm, Avanthi Inc, Sandoz, Schering Plough, Pioneer Pharms, and Schering, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for dexbrompheniramine maleate; pseudoephedrine sulfate. One supplier is listed for this compound.

Summary for dexbrompheniramine maleate; pseudoephedrine sulfate

US Patents and Regulatory Information for dexbrompheniramine maleate; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz DISOBROM dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 070770-001 Sep 30, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Schering Plough DISOPHROL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 013483-004 Sep 13, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering DISOPHROL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET;ORAL 012394-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering Plough DRIXORAL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 013483-003 Sep 13, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pioneer Pharms RESPORAL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 089139-001 Jun 16, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Avanthi Inc DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 078648-001 Feb 27, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Copley Pharm BROMPHERIL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 089116-001 Jan 22, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Mallinckrodt
Merck
McKesson
Moodys

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.