APADAZ Drug Patent Profile
✉ Email this page to a colleague
When do Apadaz patents expire, and what generic alternatives are available?
Apadaz is a drug marketed by Zevra Therap 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.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for APADAZ |
What excipients (inactive ingredients) are in APADAZ? | APADAZ excipients list |
DailyMed Link: | APADAZ at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Anatomical Therapeutic Chemical (ATC) Classes for APADAZ
US Patents and Regulatory Information for APADAZ
APADAZ is protected by six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of APADAZ is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting APADAZ
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 208653-001 | Feb 23, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
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 | ||
>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
When does loss-of-exclusivity occur for APADAZ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10266205
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012000569
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 66388
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11003347
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2480959
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 80991
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 110688
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 128
Estimated Expiration: ⤷ Try a Trial
Patent: 110246
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 48407
Estimated Expiration: ⤷ Try a Trial
Patent: 60336
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7096
Estimated Expiration: ⤷ Try a Trial
Patent: 9889
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 42862
Estimated Expiration: ⤷ Try a Trial
Patent: 12532142
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3046
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12000128
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7235
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 05541
Estimated Expiration: ⤷ Try a Trial
Patent: 12103476
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 7445
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1109438
Estimated Expiration: ⤷ Try a Trial
Patent: 1300747
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1655972
Estimated Expiration: ⤷ Try a Trial
Patent: 1795330
Estimated Expiration: ⤷ Try a Trial
Patent: 1877467
Estimated Expiration: ⤷ Try a Trial
Patent: 1971223
Estimated Expiration: ⤷ Try a Trial
Patent: 2038260
Estimated Expiration: ⤷ Try a Trial
Patent: 120048589
Estimated Expiration: ⤷ Try a Trial
Patent: 160106781
Estimated Expiration: ⤷ Try a Trial
Patent: 170124638
Estimated Expiration: ⤷ Try a Trial
Patent: 180081176
Estimated Expiration: ⤷ Try a Trial
Patent: 190042115
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 2916
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering APADAZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20180081176 | 히드로코돈의 벤조산, 벤조산 유도체 및 헤테로아릴 카르복실산 콘쥬게이트, 이의 전구약물, 제조 방법 및 용도 (BENZOIC ACID BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE PRODRUGS METHODS OF MAKING AND USE THEREOF) | ⤷ Try a Trial |
South Korea | 20190042115 | 히드로코돈의 벤조산, 벤조산 유도체 및 헤테로아릴 카르복실산 콘쥬게이트, 이의 전구약물, 제조 방법 및 용도 (BENZOIC ACID BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE PRODRUGS METHODS OF MAKING AND USE THEREOF) | ⤷ Try a Trial |
Israel | 217096 | תכשירים הכוללים תצמידים של בנזואט הידרוקודון ושימושים בהם (Compositions comprising conjugates of benzoate hydrocodone and use thereof) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |