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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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Saphris (2023)

Total Spending

$9.0M

Total Claims

7,740

Beneficiaries

1,135

Avg Cost/Unit

$20.70

Spending Trend

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

YoY Change:+2.7%

5yr CAGR:+0.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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