CARGLUMIC ACID - Generic Drug Details

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What are the generic sources for carglumic acid and what is the scope of freedom to operate?

Carglumic acid is the generic ingredient in two branded drugs marketed by Recordati Rare, Navinta Llc, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for carglumic acid. Four suppliers are listed for this compound.

Summary for CARGLUMIC ACID

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	4
Patent Applications:	324
Drug Prices:	Drug price trends for CARGLUMIC ACID
What excipients (inactive ingredients) are in CARGLUMIC ACID?	CARGLUMIC ACID excipients list
DailyMed Link:	CARGLUMIC ACID at DailyMed

See drug prices for CARGLUMIC ACID

Recent Clinical Trials for CARGLUMIC ACID

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

Sponsor	Phase
National Taiwan University Hospital	N/A
King Abdullah International Medical Research Center	Phase 3
University Hospitals Cleveland Medical Center	Phase 2

See all CARGLUMIC ACID clinical trials

Pharmacology for CARGLUMIC ACID

Drug Class	Carbamoyl Phosphate Synthetase 1 Activator
Mechanism of Action	Carbamoyl Phosphate Synthetase 1 Activators

Anatomical Therapeutic Chemical (ATC) Classes for CARGLUMIC ACID

A16AA	Amino acids and derivatives
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for CARGLUMIC ACID

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Navinta Llc	CARGLUMIC ACID	carglumic acid	TABLET, FOR SUSPENSION;ORAL	213395-001	Jun 22, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	CARGLUMIC ACID	carglumic acid	TABLET, FOR SUSPENSION;ORAL	213729-001	Oct 13, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recordati Rare	CARBAGLU	carglumic acid	TABLET, FOR SUSPENSION;ORAL	022562-001	Mar 18, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for CARGLUMIC ACID

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International BV	Ucedane	carglumic acid	EMEA/H/C/004019 Ucedane is indicated in treatment of:hyperammonaemia due to N-acetylglutamate synthase primary deficiency;Hyperammonaemia due to isovaleric acidaemia;Hyperammonaemia due to methymalonic acidaemia;Hyperammonaemia due to propionic acidaemia.	Authorised	yes	no	no	2017-06-23
Recordati Rare Diseases	Carbaglu	carglumic acid	EMEA/H/C/000461 Carbaglu is indicated in treatment of:hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.	Authorised	no	no	no	2003-01-24
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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