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Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dextromethorphan hydrobromide; quinidine sulfate?

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

This ingredient has forty-nine patent family members in twenty countries.

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

Summary for Generic Name: dextromethorphan hydrobromide; quinidine sulfate

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packagers: see list1
Clinical Trials: see list328
Drug Prices:see low prices
DailyMed Link:dextromethorphan hydrobromide; quinidine sulfate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes7,659,282► Subscribe ► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes8,227,484► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,166,207► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,206,248► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RE38115► Subscribe
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International Patent Family for Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Country Document Number Estimated Expiration
Israel211593► Subscribe
South Korea20120089706► Subscribe
Taiwan200403997► Subscribe
Slovenia1539166► Subscribe
Israel166166► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130030 00105Estonia► SubscribePRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1Finland► Subscribe
00626Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624
8 5023-2013Slovakia► SubscribePRODUCT NAME: MONOHYDRAT DEXTROMETORFANU HYDROBROMIDU/- DIHYDRAT CHINIDINSULFATU; REGISTRATION NO/DATE: EU/1/13/833 20130624
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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.

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