ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for acetaminophen; benzhydrocodone hydrochloride and what is the scope of freedom to operate?
Acetaminophen; benzhydrocodone hydrochloride
is the generic ingredient in one branded drug marketed by Zevra Therap and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Acetaminophen; benzhydrocodone hydrochloride has thirty-five patent family members in twenty countries.
Summary for ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
| International Patents: | 35 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Generic Entry Date for ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zevra Therap | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-002 | Jan 4, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Zevra Therap | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-003 | Jan 4, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Zevra Therap | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-003 | Jan 4, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20120048589 | BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2011002991 | ⤷ Try a Trial | |
| South Africa | 201109438 | BENZOIC ACID,BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE,PRODRUGS,METHODS OF MAKING AND USE THEREOF | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
