APADAZ Drug Patent Profile
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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. 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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Zevra Therap | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-001 | Feb 23, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Zevra Therap | APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653-002 | Jan 4, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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: ⤷ Sign Up
Brazil
Patent: 2012000569
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 66388
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11003347
Estimated Expiration: ⤷ Sign Up
China
Patent: 2480959
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 80991
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 110688
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 128
Estimated Expiration: ⤷ Sign Up
Patent: 110246
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 48407
Estimated Expiration: ⤷ Sign Up
Patent: 60336
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7096
Estimated Expiration: ⤷ Sign Up
Patent: 9889
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 42862
Estimated Expiration: ⤷ Sign Up
Patent: 12532142
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 3046
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12000128
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7235
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 05541
Estimated Expiration: ⤷ Sign Up
Patent: 12103476
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 7445
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1109438
Estimated Expiration: ⤷ Sign Up
Patent: 1300747
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1655972
Estimated Expiration: ⤷ Sign Up
Patent: 1795330
Estimated Expiration: ⤷ Sign Up
Patent: 1877467
Estimated Expiration: ⤷ Sign Up
Patent: 1971223
Estimated Expiration: ⤷ Sign Up
Patent: 2038260
Estimated Expiration: ⤷ Sign Up
Patent: 120048589
Estimated Expiration: ⤷ Sign Up
Patent: 160106781
Estimated Expiration: ⤷ Sign Up
Patent: 170124638
Estimated Expiration: ⤷ Sign Up
Patent: 180081176
Estimated Expiration: ⤷ Sign Up
Patent: 190042115
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 2916
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
Costa Rica | 20110688 | CONJUGADOS DE HIDROCODONA CON ÁCIDO BENZOICO, DERIVADOS DE ÁCIDO BENZOICO Y ÁCIDO CARBOXÍLICO HETEROARÍLICO, PROFÁRCOS, MÉTODOS DE PREPARACIÓN Y USO DE LOS MISMOS | ⤷ Sign Up |
China | 102480959 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof | ⤷ Sign Up |
Cuba | 24128 | COMPUESTO DE BENZOATO CONJUGADO A LA HIDROCODONA (BZ-HC) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |