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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 Kvk Tech Inc and is included in one NDA. There are five patents protecting this drug.
This drug has thirty-two 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. One supplier is listed for this compound. Additional details are available on the acetaminophen; benzhydrocodone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Apadaz
Apadaz was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 22nd, 2031. This may change due to patent challenges or generic licensing.
Summary for APADAZ
| International Patents: | 32 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | APADAZ at DailyMed |
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.
Synonyms for APADAZ
| Acetaminophen / benzhydrocodone hydrochloride |
| Acetaminophen and benzhydrocodone hydrochloride |
| Acetaminophen mixture with benzhydrocodone hydrochloride |
| S900007390 |
US Patents and Regulatory Information for APADAZ
International Patents for APADAZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101795330 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011002991 | Start Trial |
| New Zealand | 597235 | Start Trial |
| Japan | 2012532142 | Start Trial |
| South Korea | 20180081176 | Start Trial |
| Australia | 2010266205 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
