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

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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Fleqsuvy (2023)

Total Spending

$831K

Total Claims

398

Beneficiaries

Avg Cost/Unit

$6.22

Spending Trend

$301K(2022)→$831K(2023)

YoY Change:+7.5%

5yr CAGR:+7.5%

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

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