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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-five patent family members in twenty 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 22, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for APADAZ
| International Patents: | 35 |
| 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.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kvk Tech Inc | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-002 | Jan 4, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Kvk Tech Inc | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-001 | Feb 23, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Kvk Tech Inc | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-002 | Jan 4, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for APADAZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Costa Rica | 20110688 | Start Trial |
| Chile | 2011003347 | Start Trial |
| Japan | 2012532142 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
