Viewing data from:

LYVISPAH

NDA

BACLOFEN | N215422 | STRIDES PHARMA INTERNATIONAL AG

3 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Jul. 29, 2039

Sep. 29, 2041

Jul. 29, 2039

Sep. 29, 2041

Jul. 29, 2039

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Lyvispah (2023)

Total Spending

$144K

Total Claims

619

Beneficiaries

299

Avg Cost/Unit

$3.49

Spending Trend

$112K(2022)→$144K(2023)

YoY Change:-67.8%

5yr CAGR:-67.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Baclofen (J0475) (2023)

Total Spending

$19.4M

Total Claims

21,944

Beneficiaries

7,078

ASP Price

—

Spending Trend

$3K(2023)→$19.4M(2023)

HCPCS: J0475 — Injection, baclofen, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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
Nov 23, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG/PACKET

RLD

5 patents0 exclusivities▴

GRANULE;ORAL | Approved: Nov 22, 2021

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10792262	Jul 29, 2039	—	—	Yes		—
11491125	Sep 29, 2041	—	—	Yes		—
11654124	Jul 29, 2039	—	—	Yes	—	—
11850225	Sep 29, 2041	—	—	Yes		—
11931328	Jul 29, 2039	—	—	Yes	—	—

#002 — 10MG/PACKET

RLD

5 patents0 exclusivities▾

GRANULE;ORAL | Approved: Nov 22, 2021

#003 — 20MG/PACKET

RLD

5 patents0 exclusivities▾

GRANULE;ORAL | Approved: Nov 22, 2021