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: October 14, 2019

DrugPatentWatch Database Preview

DUEXIS Drug Profile

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Which patents cover Duexis, and what generic alternatives are available?

Duexis is a drug marketed by Horizon and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in fourteen countries.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Drug patent expirations by year for DUEXIS
Drug Prices for DUEXIS

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Drug Sales Revenue Trends for DUEXIS

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Generic Entry Opportunity Date for DUEXIS
Generic Entry Date for DUEXIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DUEXIS

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

SponsorPhase
Pediatric Rheumatology Collaborative Study GroupPhase 4
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 4

See all DUEXIS clinical trials

Recent Litigation for DUEXIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Horizon Medicines LLC v. Alkem Laboratories Ltd.2018-07-09
Horizon Pharma Inc. v. Par Pharmaceutical Companies, Inc.2013-01-17

See all DUEXIS litigation

Synonyms for DUEXIS
1011231-26-7
AULFVKUUIUIWQU-UHFFFAOYSA-N
Benzeneacetic acid, alpha-methyl-4-(2-methylpropyl)-, mixt. with 3-(((2-((aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-N-(aminosulfonyl)propanimidamide
Famotidine mixture with ibuprofen
HZT 501
HZT-501
Ibuprofen and famotidine
Ibuprofen Famotidine
Ibuprofen/Famotidine

US Patents and Regulatory Information for DUEXIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing   See Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for DUEXIS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 800 mg/26.6 mg ➤ Subscribe   See Pricing

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Serving leading biopharmaceutical companies globally:

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Merck

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.