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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Mapi USA, Inc. (Medunik Canada Ltd.) FDA-2016-P-4095 · 5 docket documents Mapi USA, Inc., on behalf of Medunik Canada Ltd., filed an ANDA Suitability Petition under section 505(j)(2)(C) requesting permission to file an Abbreviated New Drug Application for carglumic acid dispersible tablets in 200 mg and 50 mg strengths, which differ from the Reference Listed Drug Carbaglu	Other	2016-11-30	Partially Denied	Mapi USA, Inc. (Medunik Canada Ltd.)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Long-term Efficacy of Carglumic Acid in Organic Acidemia.NCT04284917	N/A	Completed	National Taiwan University Hospital	3	2019-11-28 → 2025-03-11
Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia NCT01599286	Phase 2	Completed	Mendel Tuchman	35	2012-09-01 → 2020-04-30
Carglumic Acid in Methylmalonic Acidemia and Propionic Acidemia NCT02426775	Phase 3	Completed	King Abdullah International Medical Research Center	33	2015-11 → 2019-03-19
N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia NCT00843921	Phase 2/3	UNKNOWN	Mendel Tuchman	52	2008-08 → 2020-06-30

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$825.53

Highest Price

$9906.36

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52276-0312-05CARGLUMIC ACID 200MG TAB,SOLUBLE	$825.53	FSS	Recordati Rare Diseases, Inc.	04/14/2026
52276-0312-05CARGLUMIC ACID 200MG TAB,SOLUBLE	$825.53	Big4	Recordati Rare Diseases, Inc.	04/14/2026
52276-0312-60CARGLUMIC ACID 200MG TAB,SOLUBLE	$9906.36	FSS	Recordati Rare Diseases, Inc.	04/14/2026
52276-0312-60CARGLUMIC ACID 200MG TAB,SOLUBLE	$9906.36	Big4	Recordati Rare Diseases, Inc.	04/14/2026

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

Medicare Part D Spending

CMS annual spending data for Carbaglu (2024)

Total Spending

$10.8M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$231.93

Spending Trend

$5.3M(2019)→$5.4M(2020)→$5.8M(2021)→$8.0M(2022)→$8.7M(2023)→$10.8M(2024)

YoY Change:-2.7%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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