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. 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
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 five 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
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No			Y	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
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)
World Intellectual Property Organization (WIPO)	2011002991
World Intellectual Property Organization (WIPO)	2011002991
Mexico	2012000128	ACIDO BENZOICO, DERIVADOS DE ACIDO BENZOICO Y CONJUGADOS DE ACIDO HETEROARIL CARBOXILICO DE HIDROCODONA, PROFARMACOS METODOS PARA ELABORALOS Y SUS USOS. (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF.)
Chile	2011003347

APADAZ Market Analysis and Financial Projection

Last updated: February 5, 2026

What are the current market dynamics for Apadaz?

Apadaz (benzhydrocodone and acetaminophen) entered the U.S. market in 2017 as an abuse-deterrent formulation of hydrocodone. Its market is influenced by increasing regulatory scrutiny, growing concern over opioid misuse, and shifting prescribing patterns favoring non-opioid alternatives.

Market share and competition

• Apadaz holds a niche position in the opioid combination segment.
• It competes against established brands such as Vicodin, Norco, and generic hydrocodone products.
• Demand has declined partly due to the opioid epidemic and tighter regulations.

Regulatory environment

• The Drug Enforcement Administration (DEA) classifies hydrocodone products as Schedule II substances.
• The FDA issued guidelines in 2018 discouraging new opioids, emphasizing risk mitigation.
• In 2021, the FDA requested removal of approval for certain opioid combos with higher abuse potential, although Apadaz remains available through existing prescriptions.

Prescriber and patient trends

• Prescribers increasingly favor non-opioid pain treatments, such as NSAIDs and acetaminophen alone.
• Patients and providers are more cautious given the risks of dependence and overdose.

How has the financial trajectory of Apadaz evolved?

Since its approval, Apadaz’s revenue has faced downward pressure. The impact of regulatory shifts and market competition has limited its growth.

Revenue performance

• Limited publicly available data; estimates suggest minimal annual sales volume.
• CAP (Compound Annual Growth Rate) approximation indicates a decline since 2018.
• No major marketing campaigns or incentives have been reported post-launch.

Pricing and reimbursement

• Apadaz’s pricing aligns with other branded hydrocodone combinations, typically $2–$4 per tablet.
• Reimbursement rates are influenced by federal policies on opioid prescriptions, often favoring generics.
• Commercial insurers and government payers increasingly restrict coverage due to opioid misuse concerns.

Future financial prospects

• The market forecast predicts continued decline due to regulatory pressures, prescriber preferences, and the opioid crisis.
• Market entry barriers limit potential growth.
• No significant pipeline developments or reformulations have been announced to revive sales.

What are the external factors influencing Apadaz's market and financial outlook?

• The ongoing opioid litigation against manufacturers impacts all opioid products.
• Federal and state legislation aims to restrict opioid prescriptions, affecting demand.
• The rise of abuse-deterrent formulations and abuse-resistant technologies shifts focus away from traditional opioids.
• Public health campaigns continue to promote non-opioid pain management, reducing user base.

Summary of key points

• Apadaz occupancy in the opioid market is marginal amidst regulatory and societal shifts against opioids.
• Revenue trajectory shows decline, with no significant recovery prospects.
• Market dynamics are further challenged by increased competition from non-opioid and abuse-deterrent alternatives.
• Regulatory policies restrict new prescriptions, decreasing revenue potential.
• External pressures like litigation and public health initiatives will continue to constrain growth.

Key Takeaways

• Apadaz’s market share is small and declining due to regulatory and societal pressures.
• Financial prospects remain limited, with minimal growth expected.
• Prescriber behaviors favor non-opioids as first-line treatments.
• Price and reimbursement pressures hinder profitability.
• Future shifts towards non-opioid pain management solutions remain a major factor.

FAQs

1. Is Apadaz still available in the market?
Yes. The FDA has not withdrawn its approval, and it remains prescribed, primarily for patients with limited options. However, prescribing frequency has decreased.

2. What factors have contributed to Apadaz’s limited sales?
Regulatory restrictions, increased opioid regulation, reimbursement challenges, prescriber caution, and the opioid epidemic’s impact have all contributed.

3. Are there any reformulations or new formulations in development?
No public announcements or filings indicate pipeline development or reformulation aimed at increasing Apadaz’s market viability.

4. How does Apadaz compare to other opioids in terms of abuse potential?
Apadaz includes abuse-deterrent features, but overall opioid abuse remains a concern limiting new use.

5. What are the legal risks associated with Apadaz?
Apadaz and similar products face ongoing litigation related to the opioid crisis involving allegations of misleading marketing and contribution to addiction.

References

[1] FDA Drug Approvals and Updates, 2017–2023.
[2] U.S. DEA Schedule and Classification Data.
[3] Industry sales estimates, Center for Drug Evaluation and Research Reports, 2023.
[4] Federal and State Legislation on Opioid Prescriptions, 2021–2023.
[5] Public health reports on opioid misuse and abuse deterrent strategies, CDC, 2022.