Viewing data from:

SAPHRIS

NDA

ASENAPINE MALEATE | N022117 | ABBVIE INC

3 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (2)TodayPED (+6 mo)

Today

7741358

Oct. 6, 2026

8022228

Oct. 6, 2026

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan Sales, LLC et al v. Breckenridge Pharmaceutical, Inc. 1:2020cv00199	D. Del.	2020-02-10	Terminated 2020-11-18	—
Forest Laboratories, LLC et al v. Breckenridge Pharmaceutical, Inc. 1:2017cv01287	D. Del.	2017-09-08	Terminated 2020-11-18	—
Forest Laboratories, LLC et al v. Hikma Pharmaceuticals LLC et al 1:2014cv01266 2 patentsANDA 206117asenapine maleate	D. Del.	2014-10-02	Terminated 2017-07-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

$21.22

per ea

Lowest NADAC/Unit

$20.99

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00456240560SAPHRIS 5 MG TAB SUBLINGUAL	$21.22	EA	Brand	$2.51	2026-06-17
00456241060SAPHRIS 10 MG TAB SUBLINGUAL	$21.19	EA	Brand	$2.74	2026-06-17
00456240260SAPHRIS 2.5 MG TAB SUBLINGUAL	$20.99	EA	Brand	$3.19	2026-06-17

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

$903.21

Highest Price

$1140.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-2410-60SAPHRIS 10MG	$1140.47	FSS	Abbvie US LLC	07/31/2030
00456-2410-60SAPHRIS 10MG	$903.88	Big4	Abbvie US LLC	07/31/2030
00456-2402-60SAPHRIS 2.5MG TAB	$1140.47	FSS	Abbvie US LLC	07/31/2030
00456-2402-60SAPHRIS 2.5MG TAB	$903.21	Big4	Abbvie US LLC	07/31/2030
00456-2405-60SAPHRIS 5MG	$1140.47	FSS	Abbvie US LLC	07/31/2030
00456-2405-60SAPHRIS 5MG	$904.87	Big4	Abbvie US LLC	07/31/2030

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

Medicare Part D Spending

CMS annual spending data for Saphris (2024)

Total Spending

$7.2M

Total Claims

6,204

Beneficiaries

933

Avg Cost/Unit

$19.61

Spending Trend

$115.4M(2019)→$107.7M(2020)→$39.9M(2021)→$12.3M(2022)→$9.0M(2023)→$7.2M(2024)

YoY Change:-5.3%

5yr CAGR:-1.2%

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

API Supply Chain10 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDASENAPINE MALEATE

DMF 257452012

OLON SPAASENAPINE MALEATE

DMF 261042012

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE AN]

DMF 267852013

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE "AOI"]

DMF 269732013

MATRIX PHARMACORP PRIVATE LTDASENAPINE MALEATE

DMF 270862013

SUN PHARMACEUTICAL INDUSTRIES LTDASENAPINE MALEATE

DMF 271852013

ALEMBIC PHARMACEUTICALS LTDASENAPINE MALEATE

DMF 271942013

MEGAFINE PHARMA P LTDASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE)

DMF 272922013

SIGMAPHARM LABORATORIES LLCASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX

DMF 273002013

ASPEN OSS BVASENAPINE MALEATE

DMF 348682020

LUPIN LTDInactiveASENAPINE MALEATE (MICRONIZED)

DMF 272852013

CHEMO IBERICA SAInactiveASENAPINE MALEATE

DMF 272902013

SIGNA SA DE CVInactiveASENAPINE MALEATE

DMF 273162013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -24	View Letter (PDF)
Mar 2, 2017	SUPPL -22	View Letter (PDF)
Jan 24, 2017	SUPPL -21	View Letter (PDF)
Jan 24, 2017	SUPPL -20	View Letter (PDF)
Mar 13, 2015	SUPPL -18	View Letter (PDF)
Mar 13, 2015	SUPPL -19	View Letter (PDF)
Mar 13, 2015	SUPPL -17	View Letter (PDF)
Nov 19, 2014	SUPPL -16	View Letter (PDF)
Nov 19, 2014	SUPPL -15	View Letter (PDF)
Nov 19, 2014	SUPPL -14	View Letter (PDF)
Oct 23, 2014	SUPPL -11	View Letter (PDF)
Mar 22, 2013	SUPPL -12	View Letter (PDF)
Nov 9, 2012	SUPPL -13	View Letter (PDF)
Oct 13, 2011	SUPPL -9	View Letter (PDF)
Aug 11, 2011	SUPPL -10	View Letter (PDF)
Dec 7, 2010	SUPPL -7	View Letter (PDF)
Sep 21, 2010	SUPPL -4	View Letter (PDF)
Sep 21, 2010	SUPPL -3	View Letter (PDF)
Aug 26, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE

RLDAB

2 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Aug 13, 2009

Patents (2) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7741358	Apr 6, 2026PED: Oct 6, 2026	PED	Yes	Yes		—
8022228	Apr 6, 2026PED: Oct 6, 2026	PED	Yes	Yes	—	—

#002 — EQ 10MG BASE

RLDAB

2 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Aug 13, 2009

#003 — EQ 2.5MG BASE

RLDAB

2 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Mar 12, 2015