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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Accenture
Healthtrust
Cerilliant
Queensland Health
Harvard Business School
Fuji
Deloitte
Dow

Generated: July 15, 2018

DrugPatentWatch Database Preview

Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; quinidine sulfate and what is the scope of dextromethorphan hydrobromide; quinidine sulfate patent protection?

Dextromethorphan hydrobromide; quinidine sulfate
is the generic ingredient in two branded drugs marketed by Actavis Elizabeth and Avanir Pharms, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; quinidine sulfate has sixty-four patent family members in twenty-one countries.

There are twenty-three drug master file entries for dextromethorphan hydrobromide; quinidine sulfate. One supplier is listed for this compound.

US Patents and Regulatory Information for dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Elizabeth DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 202934-001 Oct 10, 2017 AB RX No No ➤ 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

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Expired US Patents for dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Sign Up ➤ Sign Up
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Sign Up ➤ Sign Up
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130030 00105 Estonia ➤ Sign Up PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
8 5023-2013 Slovakia ➤ Sign Up PRODUCT NAME: MONOHYDRAT DEXTROMETORFANU HYDROBROMIDU/- DIHYDRAT CHINIDINSULFATU; REGISTRATION NO/DATE: EU/1/13/833 20130624
13/055 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Baxter
Merck
Farmers Insurance
Fish and Richardson
Deloitte
QuintilesIMS
Cipla
Citi

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