Apadaz is a drug owned by Zevra Therapeutics. It is protected by 5 US drug patents filed from 2018 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 22, 2031. Details of Apadaz's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8461137 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof |
Feb, 2031
(5 years from now) | Active |
| US9549923 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof |
Jul, 2030
(4 years from now) | Active |
| US9132125 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof |
Jul, 2030
(4 years from now) | Active |
| US8748413 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof |
Jul, 2030
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8828978 | Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof |
Jul, 2030
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Apadaz's patents.
Latest Legal Activities on Apadaz's Patents
Given below is the list of recent legal activities going on the following patents of Apadaz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 23 Feb, 2023 | US9132125 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 02 Mar, 2022 | US8828978 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 Oct, 2021 | US8748413 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 12 Oct, 2020 | US8461137 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 21 May, 2020 | US9549923 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 22 Feb, 2019 | US9132125 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 22 Feb, 2018 | US8828978 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Nov, 2017 | US8748413 |
| Recordation of Patent Grant Mailed Critical | 24 Jan, 2017 | US9549923 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2017 | US9549923 |
US patents provide insights into the exclusivity only within the United States, but Apadaz is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Apadaz's family patents as well as insights into ongoing legal events on those patents.
Apadaz's Family Patents
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Generic Launch
Generic Release Date:
Apadaz's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 22, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Apadaz Generics:
There are no approved generic versions for Apadaz as of now.
About Apadaz
Apadaz is a drug owned by Zevra Therapeutics. It is used for managing acute severe pain requiring an opioid analgesic when other treatments are insufficient. Apadaz uses Acetaminophen; Benzhydrocodone Hydrochloride as an active ingredient. Apadaz was launched by Zevra Therap in 2019.
Approval Date:
Apadaz was approved by FDA for market use on 04 January, 2019.
Active Ingredient:
Apadaz uses Acetaminophen; Benzhydrocodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Acetaminophen; Benzhydrocodone Hydrochloride ingredient
Treatment:
Apadaz is used for managing acute severe pain requiring an opioid analgesic when other treatments are insufficient.
Dosage:
Apadaz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 325MG;EQ 6.12MG BASE | TABLET | Discontinued | ORAL |
| 325MG;EQ 8.16MG BASE | TABLET | Discontinued | ORAL |
| 325MG;EQ 4.08MG BASE | TABLET | Discontinued | ORAL |