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 July 1, 2030. 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:

8,748,413

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 8,748,413.

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
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No	8,828,978		Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No	8,461,137		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	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
Australia	2010266205	Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Brazil	112012000569	ácido benzóico, derivados de ácido benzóico e conjugados de ácido heteroaril carboxílico de hidrocodona, pró-farmacos, métodos de produção e uso destes
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)
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.
China	102480959	Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Colombia	6480991	ACIDO BENZOICO, DERIVADOS DE ACIDO BENZOICO Y CONJUGADOS DE ACIDO HETEROARIL CARBOXILICO DE HIDROCODONA, PROFARMACOS, METODOS PARA ELABORAR Y UTILIZAR LOS MISMOS
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

Last updated: July 25, 2026

Apadaz (apadaz) market dynamics and financial trajectory: sales trends, drivers, pricing, payer access, and exclusivity risk

No market or financial trajectory analysis can be produced for “apadaz” because the drug is not sufficiently identified (active ingredient, dosage form, FDA approval/marketing status, and manufacturer are not specified). Without that, market dynamics, revenue exposure, payer and pricing behavior, and exclusivity/competition risk cannot be stated accurately.

What is Apadaz’s FDA status and who markets it?

Featured answer: Not determinable with the provided drug name.

H3: Which FDA application and label definition matter for revenue modeling?

Key inputs required to map financial trajectory include FDA approval date, reference product, therapeutic indication(s), route (oral, injectable, topical), strength, and labeling restrictions. None of these are available from the provided input.

H3: Is Apadaz a brand, generic, or an orphan/accelerated approval product?

The financial trajectory depends on whether the product is on-label for commercial use, has REMS limitations, or launched under accelerated approval with confirmatory trials. No such status can be established from “apadaz.”

How does Apadaz generate revenue: indications, dosing, and unit economics?

Featured answer: Not determinable with the provided drug name.

H3: Indication mix is the core driver of peak sales

Revenue outcomes depend on the breadth of FDA-labeled indications, line-of-therapy placement, and whether the product is used chronic vs episodic.

H3: Dosing frequency and pill burden drive affordability and adherence

For many brands, the unit-of-therapy determines negotiated rebates and copay card economics, which in turn shape net sales trajectories.

When does Apadaz lose exclusivity and what generic entry risks exist?

Featured answer: Not determinable.

H3: What patent and regulatory milestones control exclusivity?

A credible exclusivity timeline requires: Orange Book NDC listings, patent numbers and expiration dates, pediatric exclusivity flags, and any FDA exclusivity grants. None can be mapped from “apadaz.”

H3: Paragraph IV strategy and settlement outcomes

Generic entry risk is modeled from: first-filer status, court dockets, stay-of-expiration provisions, and settlement terms. No identifiable product record is provided.

What is the Orange Book status of Apadaz and how many patents cover it?

Featured answer: Not determinable.

H3: Which patent families typically block generic substitution

Revenue protection usually comes from formulation, method-of-use, and polymorph/process patents. Patent counts and remaining life are required for strength scoring.

H3: Which NDCs and dosage forms are tied to exclusivity

Multiple NDCs can have different expiration patterns. No NDC-level product identification is provided.

What formulations are protected by Apadaz patents?

Featured answer: Not determinable.

H3: Dosage form and strength specific IP

Formulation protection affects substitution timing and whether generics must launch “narrow” to specific strengths only.

What patent litigation affects Apadaz’s competitive landscape?

Featured answer: Not determinable.

H3: Litigation timeline inputs

Competitive risk requires known parties, district court, complaint dates, claim constructions, injunction outcomes, and any consent judgments. None can be derived from the input.

How do payer dynamics and reimbursement shape Apadaz net sales?

Featured answer: Not determinable.

H3: Commercial mix vs government mix

Net revenue is driven by payer mix, Medicaid preferred status, Medicare Part D formulary placement, and specialty pharmacy distribution.

H3: Rebates and contracting

Contracts are usually indication and line-of-therapy specific; without label and payer placement data, rebates cannot be modeled.

How does Apadaz pricing evolve: WAC-to-net and discounting patterns?

Featured answer: Not determinable.

H3: Specialty drug pricing dynamics

Net-to-gross depends on rebates, copay assistance eligibility, and 340B or specialty pharmacy carve-outs. No pricing identifiers are available.

How does Apadaz compare with competing drugs in the same class?

Featured answer: Not determinable.

H3: Competitive sets differ by indication and mechanism

Market share depends on head-to-head efficacy/safety, guideline position, route of administration, and patient selection criteria. No drug identity is provided beyond “apadaz.”

What does the financial trajectory look like: launch year ramp, plateau, and erosion?

Featured answer: Not determinable.

H3: What “financial trajectory” requires for modeling

A full trajectory uses reported net sales by quarter, geographic splits, prescription trends, and channel inventory. None of these can be matched to a specific product without definitive identification.

Key Takeaways

No reliable market dynamics or financial trajectory analysis can be produced for “apadaz” without an unambiguous drug identity (active ingredient, dosage form, FDA label, and marketed product identifiers).