Viewing data from:

CARBAGLU

NDA

CARGLUMIC ACID | N022562 | RECORDATI RARE DISEASES INC

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

ODE-345

Jan. 22, 2028

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 Carbaglu (2023)

Total Spending

$8.7M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$238.44

Spending Trend

$5.3M(2019)→$5.4M(2020)→$5.8M(2021)→$8.0M(2022)→$8.7M(2023)

YoY Change:-2.0%

5yr CAGR:+3.4%

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

API Supply Chain5 active DMFs

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPACARGLUMIC ACID

DMF 269552013

NOVITIUM PHARMA LLCCARGLUMIC ACID

DMF 331662018

PROCOS SPACARGLUMIC ACID

DMF 384772023

DIPHARMA SACARGLUMIC ACID

DMF 393292024

SCL LIFESCIENCES LTDCARGLUMIC ACID

DMF 408842025

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2024	SUPPL -14	View Letter (PDF)
Aug 6, 2021	SUPPL -13	View Letter (PDF)
Jan 25, 2021	SUPPL -8	View Letter (PDF)
Jan 25, 2021	SUPPL -9	View Letter (PDF)
Aug 27, 2020	SUPPL -12	View Letter (PDF)
Dec 26, 2019	SUPPL -11	View Letter (PDF)
Nov 17, 2017	SUPPL -5	View Letter (PDF)
Aug 6, 2013	SUPPL -2	View Letter (PDF)
Mar 22, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLDAB

0 patents1 exclusivity▴

TABLET, FOR SUSPENSION;ORAL | Approved: Mar 18, 2010

Exclusivities (1)

Code	Date	Status
ODE-345	Jan 22, 2028	Active