APADAZ Drug Patent Profile

Which patents cover Apadaz, and when can generic versions of Apadaz launch?

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

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
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	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 Africa	201300747	BENZOIC ACID,BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE,PRODRUGS,METHODS OF MAKING AND USE THEREOF
Israel	217096	תכשירים הכוללים תצמידים של בנזואט הידרוקודון ושימושים בהם (Compositions comprising conjugates of benzoate hydrocodone and use thereof)
Cuba	20110246
Canada	2766388	ACIDE BENZOIQUE, DERIVES D'ACIDE BENZOIQUE ET CONJUGUES D'ACIDEHETEROARYLCARBOXYLIQUEE D'HYDROCODONE, PROMEDICAMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
South Korea	101971223
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
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.)

Summary:
APADAZ (hydrocodone bitartrate and acetaminophen) is a combination opioid pain reliever approved by the FDA in 2013. Its market prospects depend heavily on regulatory trends, patent status, and market demand for opioid analgesics amidst increasing scrutiny and legislative restrictions. Competitive analysis shows limited differentiation from established opioids, with ongoing patent and formulation challenges influencing investment valuation.

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What Is the Current Market Position of APADAZ?

APADAZ operates in the prescription opioid analgesic space, primarily used for moderate to severe pain. It faces limited direct competition due to its specific formulation (hydrocodone and acetaminophen) but competes broadly with other opioids such as oxycodone, morphine, and fentanyl derivatives. Market approval was based on the convenience of its combination formulation, but its share remains modest given the broader opioid market’s decline.

The design of APADAZ involves a Schedule III classification, aligning it with controlled substances that face formulary restrictions and prescribing limitations. The company's commercialization efforts, depending on licensing or direct marketing, impact revenue potential.

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What Are the Key Fundamentals Influencing Investment?

1. Patent and Regulatory Status:
   APADAZ's formulation received FDA approval in 2013. Patent exclusivity likely lasted until 2024, though patents on common formulations are often challenged; subsequent formulations or delivery systems could extend protection. Patent expirations dampen exclusive market access, allowing generics to enter and erode margins.

2. Market Capacity and Growth Dynamics:
   Despite FDA approval, the opioid market faces significant headwinds due to the opioid epidemic, legislative restrictions, and increased prescribing guidelines. Market size for hydrocodone products has shrunk as healthcare providers reduce opioid prescriptions. The U.S. prescription pain management market was valued at approximately $17 billion in 2022 but has contracted for opioids.

3. Regulatory Risks and Litigation:
   Changing opioid prescribing policies and global efforts to curtail opioid misuse impact future sales. Potential legal liabilities or increased restrictions on opioids can reduce APADAZ’s market viability.

4. Pipeline and Formulation Innovations:
   Limited pipeline activity surrounding APADAZ may negate growth prospects. Innovations such as abuse-deterrent formulations or alternative delivery mechanisms could enhance competitiveness but are not currently reported.

5. Competitive Landscape:
   Patent expirations and generic manufacturing reduce pricing power. Several generic hydrocodone-acetaminophen formulations dominate the pharmacy shelves, limiting APADAZ’s market share potential.

6. Revenue and Financials:
   Available public financials indicate minimal revenue from APADAZ, with some reports suggesting declining or negligible contributions. The focus shifts toward cost management and regulatory compliance rather than growth.

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What Are the Investment Risks?

• Erosion of patent protection due to generic entries.
• Legislative measures limiting opioid prescribing, including Prescription Drug Monitoring Programs and reclassification of opioids.
• Litigation risks from opioid-related lawsuits.
• Market shifts favoring non-opioid pain management alternatives.
• Negative public perception and increased scrutiny affecting prescribing behavior.

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What Are the Strategic Opportunities?

• Development of abuse-deterrent formulations to meet regulatory standards.
• Entry into emerging markets with less restrictive opioid policies.
• Partnership or licensing agreements for formulations or combinations with novel delivery systems.
• Diversification into non-opioid analgesic drugs with higher growth potential.

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Key Takeaways:

Last updated: February 3, 2026

• APADAZ’s revenue trajectory depends on patent protection and market demand amidst regulatory constraints.
• The decline of opioid prescribing and increased scrutiny diminish future market opportunities.
• Patent expiration, coupled with generic competition, significantly reduces potential profitability.
• Innovation in formulations may extend product lifecycle but is not currently evident.
• Investment in APADAZ carries notable regulatory, legal, and market risks, with limited upside unless strategic pivots occur.

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FAQs

1. When did APADAZ receive FDA approval, and what protections did it initially have?
APADAZ was approved in 2013 with patent protections lasting approximately 7–10 years; patent expirations are expected around 2024, allowing generics to enter the market.

2. How does the opioid epidemic influence APADAZ’s market potential?
The epidemic led to tighter prescribing regulations, legislative restrictions, and reduced demand for opioid products, including APADAZ, impacting its sales.

3. What is the competitive landscape for hydrocodone-acetaminophen formulations?
Multiple generic versions dominate retail channels, eroding market share from branded or innovator products like APADAZ.

4. Are there any development pipelines or formulations that could extend APADAZ’s viability?
No significant public evidence indicates ongoing development or reformulation efforts to extend APADAZ’s lifecycle.

5. Should investors consider APADAZ as a growth asset?
Given patent expiration, market decline, and regulatory challenges, APADAZ presents limited growth prospects; risks outweigh potential upside without strategic innovation.

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References

[1] FDA. (2013). "FDA Approves New Opioid Pain Medication."
[2] IQVIA. (2022). "US Prescription Pain Market Report."
[3] CDC. (2022). "Opioid Prescribing Guidelines and Trends."
[4] U.S. Patent Office. (2024). "Patent Status for Hydrocodone-Containing Formulations."
[5] Statista. (2022). "Market Value of Prescription Opioids in the US."