Viewing data from:

LATUDA

NDA

LURASIDONE HYDROCHLORIDE | N200603 | SUNOVION PHARMACEUTICALS INC

5 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Expired (4)Active (2)TodayPED (+6 mo)IPRPTAB Challenge

2027

2028

2029

2030

2031

2032

Today

Nov. 26, 2026

Nov. 26, 2026

Nov. 23, 2031

May. 26, 2026IPR

May. 23, 2031

Nov. 26, 2026

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2017-01292	9555027	IPR	Par Pharmaceutical, Inc.	Terminated-Settled	2017-04-18	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

9 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
PIRAMAL HEALTHCARE UK LIMITED v. SUMITOMO DAINIPPON PHARMA CO., LTD. et al 2:2019cv14307 3 patentsANDA 212091lurasidone hydrochloride	D.N.J.	2019-06-26	Terminated 2019-11-26	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. ALKEM LABORATORIES LIMITED 2:2018cv14787 2 patentsANDA 212244lurasidone hydrochloride	D.N.J.	2018-10-09	Terminated 2019-01-02	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. MACLEODS PHARMACEUTICALS LTD. et al 2:2018cv13833 2 patentsANDA 212124lurasidone hydrochloride	D.N.J.	2018-09-12	Terminated 2019-01-14	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. PIRAMAL HEALTHCARE UK LIMITED 2:2018cv13478 2 patentsANDA 212091lurasidone hydrochloride	D.N.J.	2018-08-31	Terminated 2019-11-25	—
Sumitomo Dainippon Pharma Co., Ltd. et al v. First Time US Generics, LLC 1:2018cv00369	D. Del.	2018-03-08	Terminated 2018-05-01	—
Sumitomo Dainippon Pharma Co., Ltd. et al v. Amneal Pharmaceuticals, LLC 1:2018cv00256	D. Del.	2018-02-13	Terminated 2018-05-01	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. EMCURE PHARMACEUTICALS LTD 2:2018cv02065 2 patentslurasidone	D.N.J.	2018-02-13	Terminated 2018-11-27	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. AMNEAL PHARMACEUTICALS LLC. 2:2016cv04596 1 patentANDA 208002lurasidone hydrochloride	D.N.J.	2016-07-29	Terminated 2019-02-04	—
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. EMCURE PHARMACEUTICALS LIMITED et al 2:2015cv00280 1 patentANDA 208058lurasidone hydrochloride	D.N.J.	2015-01-14	Terminated 2017-02-28	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

63 trials from ClinicalTrials.gov — 2 recruiting, 58 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101 NCT07785102	Early Phase 1	Not Yet Recruiting	Mclean Hospital	30	2026-09-01 → 2027-03-31
Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy NCT07781293	Phase 3	Not Yet Recruiting	Bukwang Pharmaceutical	364	2026-09-28 → 2027-10
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects NCT00549666	Phase 1	Completed	Sumitomo Pharma America, Inc.	23	2007-08 → 2007-12
Pediatric Schizophrenia Efficacy and Safety Study NCT01911429	Phase 3	Completed	Sumitomo Pharma America, Inc.	327	2013-08 → 2015-12
Sequential Therapy for the Treatment of Severe Bipolar Depression.NCT02974010	Phase 2	Completed	NeuroRx, Inc.	22	2018-01-15 → 2019-11-20
Biosignatures of Latuda for Bipolar Depression NCT02239094	N/A	Completed	New York State Psychiatric Institute	20	2015-01 → 2016-09
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression NCT01284517	Phase 3	Completed	Sumitomo Pharma America, Inc.	356	2010-11 → 2012-08
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296 NCT01575561	Phase 3	Completed	Sumitomo Pharma America, Inc.	377	2012-06 → 2015-07
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression NCT00868959	Phase 3	Completed	Sumitomo Pharma America, Inc.	817	2009-04 → 2013-02
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex NCT01358357	Phase 3	Completed	Sumitomo Pharma America, Inc.	965	2011-06 → 2015-04

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$69.28

per ea

Lowest NADAC/Unit

$46.36

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
63402031230LATUDA 120 MG TABLET	$69.28	EA	Brand	$0.4824	2026-08-19
63402030430LATUDA 40 MG TABLET	$46.97	EA	Brand	$0.2134	2026-08-19
63402030630LATUDA 60 MG TABLET	$46.80	EA	Brand	$0.2860	2026-08-19
63402030230LATUDA 20 MG TABLET	$46.46	EA	Brand	$0.1376	2026-08-19
63402030830LATUDA 80 MG TABLET	$46.36	EA	Brand	$0.3273	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$1053.50

Highest Price

$1748.21

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63402-0302-30LATUDA 20MG TAB	$1053.50	Big4	Sumitomo Pharma America, Inc.	07/31/2026
63402-0302-30LATUDA 20MG TAB	$1171.15	FSS	Sumitomo Pharma America, Inc.	07/31/2026
63402-0304-30LATUDA 40MG TABLETS	$1054.37	Big4	Sumitomo Pharma America, Inc.	07/31/2026
63402-0304-30LATUDA 40MG TABLETS	$1171.15	FSS	Sumitomo Pharma America, Inc.	07/31/2026
63402-0306-30LATUDA 60MG TAB	$1056.47	Big4	Sumitomo Pharma America, Inc.	07/31/2026
63402-0306-30LATUDA 60MG TAB	$1171.15	FSS	Sumitomo Pharma America, Inc.	07/31/2026

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Latuda (2024)

Total Spending

$39.6M

Total Claims

24,193

Beneficiaries

6,273

Avg Cost/Unit

$48.06

Spending Trend

$1.2B(2019)→$1.3B(2020)→$1.4B(2021)→$1.4B(2022)→$455.2M(2023)→$39.6M(2024)

YoY Change:-6.9%

5yr CAGR:+0.5%

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

API Supply Chain33 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 267002013

ALIVUS LIFE SCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 274522013

MSN PHARMACHEM PRIVATE LTDLURASIDONE HYDROCHLORIDE [ROUTE CODE - LN"]

DMF 275702013

ALP PHARM BEIJING CO LTDLURASIDONE HYDROCHLORIDE

DMF 275842013

AMSA SPALURASIDONE HYDROCHLORIDE

DMF 278982014

LUPIN MANUFACTURING SOLUTIONS LTDLURASIDONE HYDROCHLORIDE

DMF 279632014

HETERO DRUGS LTDLURASIDONE HYDROCHLORIDE

DMF 279702014

MATRIX PHARMACORP PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 281262014

TORRENT PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 281642014

TAPI NL BVLURASIDONE HYDROCHLORIDE

DMF 281782014

RAKS PHARMA PVT LTDLURASIDONE HYDROCHLORIDE

DMF 282522014

ZYDUS LIFESCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 282812014

SUN PHARMACEUTICAL INDUSTRIES LTDLURASIDONE HYDROCHLORIDE

DMF 284172014

INTAS PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 284472014

APITORIA PHARMA PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 284482014

EDMOND PHARMA SRLLURASIDONE HYDROCHLORIDE

DMF 287232014

PIRAMAL PHARMA LTDLURASIDONE HYDROCHLORIDE

DMF 291632015

UNICHEM LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 291912015

NEULAND LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 297942016

ALEMBIC PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 300922015

SOLARA ACTIVE PHARMA SCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 304642016

JUBILANT PHARMOVA LTDLURASIDONE HYDROCHLORIDE

DMF 313802017

COHANCE LIFESCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 318012017

MACLEODS PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 319542017

HISUN PHARMACEUTICAL NANTONG CO LTDLURASIDONE HYDROCHLORIDE

DMF 320022017

PROCOS SPALURASIDONE HYDROCHLORIDE

DMF 338722019

MSN PHARMACHEM PRIVATE LTDLURASIDONE

DMF 340812019

METROCHEM API PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 347562020

LEE PHARMA LTDLURASIDONE HYDROCHLORIDE

DMF 364922021

BIOCON LTDLURASIDONE HYDROCHLORIDE

DMF 395742024

ALKEM LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 395702024

MEGAFINE PHARMA P LTDLURASIDONE HYDROCHLORIDE

DMF 403752024

MICRO LABS LTDLURASIDONE HYDROCHLORIDE

DMF 405672024

APOTEX PHARMACHEM INDIA PVT LTDInactiveLURASIDONE HYDROCHLORIDE

DMF 280762014

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 -41	View Letter (PDF)
Dec 5, 2019	SUPPL -35	View Letter (PDF)
Mar 15, 2018	SUPPL -29	View Letter (PDF)
Sep 26, 2017	SUPPL -30	View Letter (PDF)
Mar 2, 2017	SUPPL -28	View Letter (PDF)
Jan 31, 2017	SUPPL -26	View Letter (PDF)
Jan 31, 2017	SUPPL -27	View Letter (PDF)
Jan 18, 2017	SUPPL -21	View Letter (PDF)
Sep 5, 2013	SUPPL -16	View Letter (PDF)
Jul 2, 2013	SUPPL -10	View Letter (PDF)
Jul 2, 2013	SUPPL -11	View Letter (PDF)
Jan 24, 2013	SUPPL -9	View Letter (PDF)
Jan 24, 2013	SUPPL -13	View Letter (PDF)
Apr 27, 2012	SUPPL -7	View Letter (PDF)
Apr 27, 2012	SUPPL -5	View Letter (PDF)
Dec 13, 2011	SUPPL -4	View Letter (PDF)
Dec 13, 2011	SUPPL -6	View Letter (PDF)
Dec 28, 2010	SUPPL -1	View Letter (PDF)
Nov 3, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 40MG

RLDAB

6 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 28, 2010

Patents (6) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8729085	May 26, 2026PED: Nov 26, 2026	PED	—	Yes	—	—
8883794	May 26, 2026PED: Nov 26, 2026	PED	—	Yes	—	—
9259423	May 23, 2031PED: Nov 23, 2031	PED	—	—		—
9555027	May 26, 2026	—	—	Yes		—
9827242	May 23, 2031	—	—	—		—
9907794	May 26, 2026PED: Nov 26, 2026	PED	—	Yes	—	—

#002 — 80MG

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2010

#003 — 20MG

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 7, 2011

#004 — 120MG

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 26, 2012

#005 — 60MG

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 12, 2013