Viewing data from:

SECUADO

NDA

ASENAPINE | N212268 | HISAMITSU PHARMACEUTICAL CO INC

3 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Jul. 25, 2033

Jul. 25, 2033

Jul. 25, 2033

Jul. 25, 2033

Jul. 25, 2033

Sep. 22, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

47 trials from ClinicalTrials.gov, 43 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)NCT00145470	Phase 3	Completed	Organon and Co	326	2005-06-02 → 2007-03-22
A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937)NCT01101464	Phase 2	Completed	Organon and Co	8	2002-10 → 2002-12
Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)NCT00156117	Phase 3	Completed	Organon and Co	417	2005-05-12 → 2006-05-30
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)NCT00174265	Phase 3	Completed	Organon and Co	196	2005-07 → 2009-05
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)NCT00143182	Phase 3	Completed	Organon and Co	504	2005-01-07 → 2006-06-28
Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)NCT00156091	Phase 3	Completed	Organon and Co	260	2005-04 → 2007-06
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)NCT00212784	Phase 3	Completed	Organon and Co	1,225	2003-09-04 → 2006-03-15
3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)NCT00159744	Phase 3	Completed	Organon and Co	488	2004-11-30 → 2006-04-29
Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)NCT01190254	Phase 3	Completed	Organon and Co	306	2010-09-28 → 2013-04-01
To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)NCT00150176	Phase 3	Completed	Organon and Co	831	2005-04 → 2008-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$49.16

per ea

Lowest NADAC/Unit

$48.88

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68968017303SECUADO 5.7 MG/24 HR PATCH	$49.16	EA	Brand	—	2026-06-17
68968017203SECUADO 3.8 MG/24 HR PATCH	$49.04	EA	Brand	—	2026-01-01
68968017403SECUADO 7.6 MG/24 HR PATCH	$48.88	EA	Brand	—	2026-01-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$1052.97

Highest Price

$1260.63

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68968-0172-03SECUADO 3.8MG/24HRS PATCH	$1260.63	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0172-03SECUADO 3.8MG/24HRS PATCH	$1054.15	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0173-03SECUADO 5.7MG/24HRS PATCH	$1260.63	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0173-03SECUADO 5.7MG/24HRS PATCH	$1052.97	Big4	Noven Therapeutics, LLC	10/14/2026
68968-0174-03SECUADO 7.6MG/24HRS PATCH	$1260.63	FSS	Noven Therapeutics, LLC	10/14/2026
68968-0174-03SECUADO 7.6MG/24HRS PATCH	$1055.29	Big4	Noven Therapeutics, LLC	10/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Secuado (2024)

Total Spending

$6.1M

Total Claims

4,499

Beneficiaries

873

Avg Cost/Unit

$48.16

Spending Trend

$565K(2020)→$2.2M(2021)→$3.7M(2022)→$5.0M(2023)→$6.1M(2024)

YoY Change:+2.3%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -7	View Letter (PDF)
Oct 15, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 3.8MG/24HR

RLD

6 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Oct 11, 2019

Patents (6) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9687474	Jul 25, 2033	—	—	Yes	—	—
10022445	Jul 25, 2033	—	—	Yes	—	—
10583121	Jul 25, 2033	—	—	Yes		—
10814002	Jul 25, 2033	—	—	Yes		—
11123305	Jul 25, 2033	—	—	Yes	—	—
11813364	Sep 22, 2033	—	—	Yes	—	—

#002 — 5.7MG/24HR

RLD

6 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Oct 11, 2019

#003 — 7.6MG/24HR

RLD

6 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Oct 11, 2019