Viewing data from:

FLEQSUVY

NDA

BACLOFEN | N215602 | AZURITY PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

11324696

Sep. 29, 2037

11446246

Sep. 8, 2037

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
AZURITY PHARMACEUTICALS, INC. v. MSN PHARMACEUTICALS INC, et al 2:2025cv13775 2 patentsANDA 220553Baclofen	D.N.J.	2025-07-25	Terminated 2025-11-13	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

88 trials from ClinicalTrials.gov, 60 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients NCT01738282	Phase 3	Completed	Ethypharm	316	2012-12 → 2014-07
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence NCT01980706	Phase 2	Completed	University of North Carolina, Chapel Hill	120	2013-12-12 → 2017-10-26
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers NCT01931319	Phase 1	Completed	University of Minnesota	39	2014-01 → 2014-06
A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults NCT02001584	Phase 1	Completed	Gedeon Richter Plc.	—	— → 2014-05
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response NCT03835442	N/A	Completed	Universitaire Ziekenhuizen KU Leuven	60	2010-01 → 2019-01
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis NCT00488839	Phase 3	Completed	Impax Laboratories, LLC	173	2007-06 → 2008-05
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity NCT00221611	Phase 2	Completed	University Hospital, Ghent	80	2000-01 → 2006-08
Baclofen Treatment of Ataxia Telangiectasia NCT00640003	Early Phase 1	Completed	Johns Hopkins University	10	2007-04 → 2011-02
Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.NCT02705950	N/A	Completed	Institut Guttmann	12	2014-12 → 2017-08
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease NCT01711125	Phase 3	Completed	South West Sydney Local Health District	104	2013-03 → 2017-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$5.94

per ml

Lowest NADAC/Unit

$3.53

per ml

Brand NDCs

Generic NDCs

Avg Brand: $5.94

Avg Generic: $3.63

39% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52652600102FLEQSUVY 25 MG/5 ML SUSPENSION	$5.94	ML	Brand	$3.53	2026-01-01
52652600101FLEQSUVY 25 MG/5 ML SUSPENSION	$5.94	ML	Brand	$3.74	2026-01-01
52536060011BACLOFEN 25 MG/5 ML SUSPENSION	$3.74	ML	Generic	—	2026-06-17
52536060012BACLOFEN 25 MG/5 ML SUSPENSION	$3.53	ML	Generic	—	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 (4 FSS, 2 Big4)

Lowest Price

$198.95

Highest Price

$1664.78

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52652-6001-01FLEQSUVY 5MG/ML SUSP,ORAL	$665.91	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-6001-01FLEQSUVY 5MG/ML SUSP,ORAL	$553.66	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-6001-02FLEQSUVY 5MG/ML SUSP,ORAL	$1664.78	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-6001-02FLEQSUVY 5MG/ML SUSP,ORAL	$1375.47	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
52536-0600-11BACLOFEN 5MG/ML SUSP,ORAL	$198.95	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
52536-0600-12BACLOFEN 5MG/ML SUSP,ORAL	$486.69	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026

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

Medicare Part D Spending

CMS annual spending data for Fleqsuvy (2024)

Total Spending

$385K

Total Claims

176

Beneficiaries

Avg Cost/Unit

$5.26

Spending Trend

$301K(2022)→$831K(2023)→$385K(2024)

YoY Change:-15.4%

5yr CAGR:-4.7%

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

API Supply Chain12 active DMFs6 inactive

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

FINE CHEMICALS CORP PTY LTDBACLOFEN

DMF 64211986

PCASBACLOFEN

DMF 70771987

EXCELLA GMBH AND CO KGBACLOFEN

DMF 73111988

ZAKLADY FARMACEUTYCZNE POLPHARMA SABACLOFEN

DMF 180142005

MATRIX PHARMACORP PRIVATE LTDBACLOFEN USP

DMF 182202005

PIRAMAL PHARMA LTDBACLOFEN

DMF 284552014

UNICHEM LABORATORIES LTDBACLOFEN USP

DMF 324312018

COHANCE LIFESCIENCES LTDBACLOFEN USP

DMF 333022018

FINE CHEMICALS CORP PTY LTDBACLOFEN (PROCESS 2)

DMF 352242020

MEDILUX LABORATORIES PVT LTDBACLOFEN

DMF 356542021

MANKIND PHARMA LTDBACLOFEN USP

DMF 370112022

VIYASH LIFE SCIENCES PRIVATE LTDBACLOFEN USP

DMF 385322023

RESOLUTION CHEMICALS LTDInactiveBACLOFEN

DMF 73681988

ICFI SPAInactiveBACLOFEN

DMF 74991988

RESOLUTION CHEMICALS LTDInactiveBACLOFEN RAW MATERIAL

DMF 77241988

ERREGIERRE SPAInactiveBACLOFEN

DMF 78171988

RESOLUTION CHEMICALS LTDInactiveBACLOFEN

DMF 98371992

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveBACLOFEN

DMF 124381997

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 8, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/5ML

RLDAB

2 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Feb 4, 2022

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11324696	Sep 29, 2037	—	—	Yes	—	—
11446246	Sep 8, 2037	—	—	—		—