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Generated: December 11, 2018

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APADAZ Drug Profile

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When do Apadaz patents expire, and what generic alternatives are available?

Apadaz is a drug marketed by Kempharm and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-seven patent family members in nineteen countries.

The generic ingredient in APADAZ is acetaminophen; benzhydrocodone hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; benzhydrocodone hydrochloride profile page.

Summary for APADAZ
International Patents:27
US Patents:5
Applicants:1
NDAs:1
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:APADAZ at DailyMed
Drug patent expirations by year for APADAZ
Generic Entry Opportunity Date for APADAZ
Generic Entry Date for APADAZ*:
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.

US Patents and Regulatory Information for APADAZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kempharm APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Kempharm APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Kempharm APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Kempharm APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Kempharm APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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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Federal Trade Commission
McKesson
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Fuji

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