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Generated: March 24, 2019

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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
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.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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Paragraph IV (Patent) Challenges for DUEXIS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 800 mg/26.6 mg ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Argus Health
US Army
Cipla
Fish and Richardson

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