APADAZ Drug Patent Profile

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
Drug Prices:	Drug price information for APADAZ
What excipients (inactive ingredients) are in APADAZ?	APADAZ excipients list
DailyMed Link:	APADAZ at DailyMed

See drug prices for APADAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for APADAZ

NDA:

208653

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

APADAZ is protected by six US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No			Y

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

Brazil

Canada

Chile

China

Colombia

Costa Rica

Cuba

European Patent Office

Israel

Japan

Malaysia

Mexico

New Zealand

Russian Federation

Singapore

South Africa

South Korea

Ukraine

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	101971223
Japan	2012532142
European Patent Office	3560336	ACIDE BENZOÏQUE, DÉRIVÉS D'ACIDE BENZOÏQUE ET CONJUGUÉS D'ACIDE CARBOXYLIQUE HÉTÉROARYLE D'HYDROCODONE, PROMÉDICAMENTS, PROCÉDÉS DE FABRICATION ET D'UTILISATION (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
Chile	2011003347	Composicion farmaceutica que comprende un conjugado, correspondiente a benzoato de hidrocodona ; y uso en el tratamiento de una enfermedad, trastorno o afeccion mediada por la union de un opioide a receptores opioides.

APADAZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for APADAZ

Introduction

APADAZ, a combination of benzhydrocodone and acetaminophen, was approved by the FDA in 2018 for the short-term management of acute pain. This article delves into the market dynamics and financial trajectory of APADAZ, highlighting its unique features, market performance, and the financial health of its developer, KemPharm.

FDA Approval and Indication

APADAZ received FDA approval for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic, where alternative treatments are inadequate. This approval was based on a New Drug Application (NDA) submitted by KemPharm, utilizing the 505(b)(2) regulatory pathway, which allowed for bridging to previous findings of safety and efficacy from currently marketed reference products[4].

Abuse-Deterrent Properties

One of the key market differentiators for APADAZ is its abuse-deterrent properties. Benzhydrocodone, the prodrug component, is covalently bonded to benzoic acid, making it more difficult to abuse through methods such as snorting. Studies have shown that APADAZ has a lower Drug Liking in the first two hours after intranasal abuse compared to traditional hydrocodone-acetaminophen combinations[1][4].

Market Introduction and Growth

During the initial period of market introduction, it was expected that abuse of APADAZ would be low and sporadic as the drug gained market share. The drug's unique molecular structure and abuse-deterrent properties were anticipated to influence its adoption rate. As of recent reports, there have been significant gains in payor access, and prescription volume is beginning to grow, indicating a positive market trajectory[5].

Financial Performance of KemPharm

KemPharm, the developer of APADAZ, has seen notable financial changes in recent years. In 2021, KemPharm reported revenue of $28.65 million, a significant increase from $13.29 million in 2020. Operating expenses, including research and development, general and administrative costs, and royalty and direct contract acquisition costs, totaled $20.92 million in 2021. Despite a net loss of $8.55 million in 2021, KemPharm's balance sheet shows a solid financial position with cash, cash equivalents, and long-term investments of $127.8 million as of December 31, 2021[2].

Revenue Streams and Milestones

The commercial success of APADAZ is expected to contribute significantly to KemPharm's revenue. The company has also diversified its revenue streams through other products, such as AZSTARYS, a D-methylphenidate prodrug for the treatment of ADHD. AZSTARYS has seen substantial growth, with over 110 million commercial lives having access to the drug and a doubled sales force size in early 2022. The license agreement with Commave, an affiliate of GPC, provides additional economic benefits tied to the commercialization of AZSTARYS[3].

Market Dynamics and Competition

The opioid market is highly competitive and regulated, with a strong focus on abuse-deterrent formulations. APADAZ competes with other opioid analgesics, but its unique abuse-deterrent properties position it favorably. The rescheduling of hydrocodone IR combination products from Schedule III to Schedule II under the Controlled Substances Act in 2014 has also impacted the market, leading to a reduction in prescriptions but highlighting the need for safer alternatives like APADAZ[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of APADAZ. The FDA's approval process and the subsequent labeling highlighting the drug's lower abuse profile have been instrumental in its market positioning. Additionally, the epidemiology studies and the 505(b)(2) regulatory pathway used for its approval have provided a robust framework for its introduction and ongoing monitoring[4].

Patient Access and Prescriber Adoption

Patient access to APADAZ has been improving, with significant gains in payor access. The prescription volume is growing, indicating increasing acceptance among prescribers. The drug's bioequivalence to established reference products like Vicoprofen and Ultracet has also helped in its adoption[4].

Future Outlook

The future outlook for APADAZ is promising, given its unique features and the growing need for safer opioid alternatives. KemPharm's solid balance sheet and expanding pipeline of development assets, including KP1077 for rare sleep disorders, position the company for continued growth. The potential for earning sales milestones in 2022 and beyond is high, driven by the commercial success of APADAZ and other products like AZSTARYS[3].

Key Takeaways

• FDA Approval: APADAZ was approved for short-term management of acute pain with a lower abuse profile compared to traditional hydrocodone-acetaminophen combinations.
• Abuse-Deterrent Properties: Benzhydrocodone's molecular structure makes it more difficult to abuse.
• Financial Performance: KemPharm has seen revenue growth and maintains a solid financial position.
• Market Dynamics: APADAZ competes in a regulated opioid market with a focus on abuse-deterrent formulations.
• Regulatory Environment: FDA approval and labeling have been crucial in its market positioning.
• Patient Access: Improving payor access and growing prescription volume indicate increasing adoption.

FAQs

What is APADAZ, and how is it different from other opioid analgesics?

APADAZ is a combination of benzhydrocodone and acetaminophen, approved for the short-term management of acute pain. It is different due to its abuse-deterrent properties, achieved through the covalent bonding of hydrocodone to benzoic acid.

How was APADAZ approved by the FDA?

APADAZ was approved using the 505(b)(2) regulatory pathway, which allowed for bridging to previous findings of safety and efficacy from currently marketed reference products.

What are the financial implications of APADAZ for KemPharm?

APADAZ contributes to KemPharm's revenue growth, and the company's solid balance sheet and expanding pipeline of development assets position it for continued financial health.

How does APADAZ compare to other opioid products in terms of abuse potential?

APADAZ has a lower abuse profile compared to traditional hydrocodone-acetaminophen combinations, as evidenced by lower Drug Liking in the first two hours after intranasal abuse.

What is the current market traction for APADAZ?

APADAZ has seen significant gains in payor access, and prescription volume is beginning to grow, indicating a positive market trajectory.

Sources

1. Wikipedia: Benzhydrocodone
2. KemPharm: KemPharm Reports Fourth Quarter and Fiscal Year 2021 Financial Results
3. KemPharm: Q4 and FY 2021 Results Call - Zevra Therapeutics, Inc.
4. FDA: Apadaz™ (Benzhydrocodone HCl/Acetaminophen) - FDA
5. KemPharm: KemPharm Reports Fourth Quarter and Fiscal Year 2021 Financial Results