Product profile · United States

APADAZ

· Patent Litigation & Settlement History ↓

IngredientACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Application typeNDA

Application208653

Product003

Dosage formTABLET

RouteORAL

Strength325MG;EQ 8.16MG BASE

Approval date2019-01-04

Marketing statusDISCONTINUED

Status event—

ApplicantZEVRA THERAP

Product source

Current GenericRadar decision

Year2023

SelectionDISQUALIFIED

ReviewFINAL

Anchor typeFDA_DISCONTINUATION

Anchor date—

Patent anchor2031-02-22

Exclusivity anchor—

Protection date—

First Final ANDA—

Status event—

FDA_MARKETING_DISCONTINUED

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8748413	2030-07-01	DS/DP —	Y	N	TRUE_DS	—	—	—
8828978	2030-07-01	DP —	N	N	DP	—	—	—
9132125	2030-07-01	DS/DP/U U-2249	N	Y	DS_EQUIVALENT	—	—	—
9549923	2030-07-01	DS/DP —	N	N	DP	—	—	—
8461137	2031-02-22	DS/DP —	Y	N	TRUE_DS	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (1)

Type	Date	Role	Basis	Source
REGULATORY_STATUS	—	TERMINAL_STATUS	FDA_MARKETING_DISCONTINUED	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.