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Last Updated: September 26, 2021

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CARBAGLU Drug Patent Profile


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When do Carbaglu patents expire, and what generic alternatives are available?

Carbaglu is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in CARBAGLU is carglumic acid. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carglumic acid profile page.

Summary for CARBAGLU
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 5
Patent Applications: 238
What excipients (inactive ingredients) are in CARBAGLU?CARBAGLU excipients list
DailyMed Link:CARBAGLU at DailyMed
Drug patent expirations by year for CARBAGLU
DrugPatentWatch® Estimated Generic Entry Opportunity Date for CARBAGLU
Generic Entry Date for CARBAGLU*:
Constraining patent/regulatory exclusivity:
IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA)
NDA:
Dosage:
TABLET, FOR SUSPENSION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CARBAGLU

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Taiwan University HospitalN/A
King Abdullah International Medical Research CenterPhase 3
Lucile Packard Children's HospitalPhase 2

See all CARBAGLU clinical trials

US Patents and Regulatory Information for CARBAGLU

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Merck
AstraZeneca
McKinsey
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.