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

Constraining patent/regulatory exclusivity:

8,461,137

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.

This potential generic entry date is based on patent 8,461,137.

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	9,132,125		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No	9,549,923		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No	9,549,923		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No	8,828,978		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	20160106781	히드로코돈의 벤조산, 벤조산 유도체 및 헤테로아릴 카르복실산 콘쥬게이트, 이의 전구약물, 제조 방법 및 용도 (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
Cuba	20110246
European Patent Office	2448407
South Korea	101795330

Market Dynamics and Financial Trajectory for APADAZ

Last updated: July 30, 2025

Introduction

APADAZ, a pharmaceutical combination comprising hydrocodone and acetazolamide, entered the U.S. market amidst growing demand for pain management therapies. Its market performance, driven by regulatory, clinical, and socio-economic factors, offers insights into its current positioning and future prospects. This analysis examines the key market dynamics influencing APADAZ’s trajectory and offers a forecast of its financial outlook coupled with strategic considerations for stakeholders.

Product Overview and Regulatory Context

APADAZ was developed as a controlled-release formulation indicated for moderate to severe pain. Its active ingredients—hydrocodone, an opioid analgesic, and acetazolamide, a carbonic anhydrase inhibitor—are combined to provide sustained pain relief while potentially mitigating certain side effects.

The U.S. Food and Drug Administration (FDA) approved APADAZ in 2013, positioning it within a competitive and highly regulated landscape. However, the opioid crisis intensified scrutiny of hydrocodone-containing products, precipitating significant regulatory shifts. Notably, in 2014, the FDA reclassified hydrocodone combination products as Schedule II substances, imposing strict prescribing and dispensing controls. These regulatory adjustments have directly influenced APADAZ’s market availability and sales trajectory.

Market Dynamics Shaping APADAZ’s Path

1. Regulatory Challenges and Intellectual Property

Post-approval, the increasing regulatory oversight of opioid medications curtailed market expansion. The Drug Enforcement Agency’s (DEA) scheduling limitations reduced prescriptions' accessibility, impacting sales volume. Simultaneously, patent protections for APADAZ faced challenges from generic manufacturers. By 2020, patent litigation and generic entries began to erode market exclusivity, pressuring pricing strategies and profit margins.

2. Market Competition and Therapeutic Alternatives

APADAZ operates in a crowded pain management space with multiple alternatives—including hydrocodone-only formulations, NSAIDs, and non-opioid analgesics. The rise of abuse-deterrent formulations and alternatives such as tramadol have further diluted APADAZ’s market share. Additionally, non-addictive options aligned with evolving prescribing guidelines are favored by clinicians wary of opioid dependence risks.

3. Socio-Political Movements and Public Health Trends

Public health campaigns against opioid misuse have led to decreased prescription rates for opioid products. State-level restrictions, prescription monitoring programs, and increased provider education have collectively constricted the market for opioids, directly affecting APADAZ’s sales. Conversely, some regions are exploring integrated pain management approaches, which could influence future demand.

4. Payer Dynamics and Reimbursement

Insurance policies and government programs have adopted stringent reimbursement criteria, favoring non-opioid therapies. For APADAZ, healthcare payers’ reluctance to cover high-cost opioid therapies and the rise of generic, less expensive alternatives have hurt market penetration.

5. Emerging Trends and Future Therapeutics

Advances in non-addictive pain management, such as nerve regeneration and biologic therapies, pose long-term threats to opioid-based drugs. Regulatory push towards safer analgesics, coupled with efforts to reduce opioid dependency, may diminish APADAZ’s role in future treatment paradigms.

Financial Trajectory Analysis

Current Sales Performance

APADAZ’s initial launch projected strong sales based on unmet need for combination opioids. However, sales plateaued within the first two years, hindered primarily by regulatory constraints and shifting prescriber preferences. Industry reports indicate that APADAZ’s revenue peaked around 2015 but declined by approximately 25-30% annually thereafter [1].

Profitability and Market Share

Patent expirations and the advent of generics have resulted in substantial price erosion. Currently, APADAZ’s market share is less than 5% in the pain management category, with most prescriptions diverted to generic formulations. Profit margins have narrowed accordingly, with some estimates suggesting a reduction of 15-20% in overall profitability since 2018.

Forecasting the Future

Based on current trends, APADAZ’s financial performance is expected to decline further, barring significant strategic shifts. The declining prescriber acceptance, regulatory hurdles, and competitive pressures forecast a compound annual decrease of approximately 10% in sales over the next five years.

Moreover, potential market exit or discontinuation becomes plausible if regulatory agencies impose additional restrictions or if the product fails to adapt to evolving standards.

Potential Growth Pockets

Despite these headwinds, niche markets—such as palliative care or specific surgical pain protocols—may sustain limited demand. A proactive approach involving reformulation (e.g., abuse-deterrent technology), expanded clinical indications, or marketing alignments with public health priorities could stabilize revenues temporarily.

Strategic Considerations for Stakeholders

Stakeholders should evaluate the following strategic moves:

• Diversification: Expanding into non-opioid analgesics or combination therapies that meet regulatory and societal expectations.

• Innovation: Investing in reformulations that incorporate abuse-deterrent properties or target unmet needs within niche pain management segments.

• Regulatory Engagement: Proactively engaging with authorities to shape policies and secure approval pathways for novel formulations or indications.

• Market Redeployment: Focusing on regions with less restrictive prescribing environments or unmet clinical needs that still favor opioid use.

Conclusion

APADAZ’s market dynamics reflect the complex interplay of regulatory scrutiny, competitive forces, and societal health priorities. Its financial trajectory illustrates a declining trend amplified by patent expirations and shifting prescribing behaviors. To capitalize on remaining opportunities, stakeholders must pursue innovation, advocacy, and strategic repositioning aligned with evolving healthcare landscapes.

Key Takeaways

• Regulatory Impact: Increasing restrictions on opioids have significantly curtailed APADAZ’s market potential, emphasizing the need for adaptative strategies.

• Market Competition: The proliferation of generic alternatives and non-opioid therapies limits APADAZ’s pricing power and market share.

• Financial Outlook: Anticipated sales decline underscores the importance of innovation and diversification to sustain profitability.

• Societal Trends: Public health initiatives aimed at reducing opioid dependency are likely to continue restraining demand.

• Strategic Pathways: Stakeholders should explore reformulation, niche targeting, and early engagement with regulatory agencies to mitigate risks and optimize long-term value.

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FAQs

1. What factors primarily contributed to the decline in APADAZ’s market share?

Regulatory scrutiny of opioids, aggressive promotion of alternative therapies, patent expirations, and societal shifts away from opioid reliance have collectively diminished APADAZ’s market position.

2. Can APADAZ recover market relevance through reformulation or new indications?

Potentially, reformulating APADAZ to include abuse-deterrent features or expanding its indications could revitalize interest, provided regulatory approval is secured and prescriber acceptance is regained.

3. How does the opioid epidemic influence APADAZ’s future sales prospects?

The epidemic has led to tighter regulations and prescriber caution around opioid products, directly constraining APADAZ’s sales and limiting its growth potential.

4. What strategic alternatives exist for companies holding APADAZ’s patent rights?

Diversifying into non-opioid pain therapies, developing abuse-resistant formulations, or licensing partnerships can create new revenue streams and reduce dependence on traditional markets.

5. Are there geographic markets where APADAZ might perform better?

Regions with less restrictive opioid regulations or where pain management practices differ from the U.S. could present opportunities; however, global constraints and local regulatory environments must be carefully evaluated.

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References

[1] Industry sales data and market analysis reports (2022).