L-glutamine - Generic Drug Details

What are the generic sources for l-glutamine and what is the scope of patent protection?

L-glutamine is the generic ingredient in two branded drugs marketed by Emmaus Medcl and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-five drug master file entries for l-glutamine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for l-glutamine

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	45
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	188
Clinical Trials:	185
Patent Applications:	198
Formulation / Manufacturing:	see details
DailyMed Link:	l-glutamine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for l-glutamine

Constraining patent/regulatory exclusivity:

TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER.

Dosage:

FOR SOLUTION;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 l-glutamine

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

Sponsor	Phase
University of New Mexico	Phase 4
Anahuac University	N/A
David J. Cangemi	Phase 1/Phase 2

See all l-glutamine clinical trials

Generic filers with tentative approvals for L-GLUTAMINE

Applicant	Application No.	Strength	Dosage Form
		5G	POWDER;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for l-glutamine

Drug Class

Amino Acid

US Patents and Regulatory Information for l-glutamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emmaus Medcl	ENDARI	l-glutamine	FOR SOLUTION;ORAL	208587-001	Jul 7, 2017		RX	Yes	No
Emmaus Medcl	NUTRESTORE	l-glutamine	FOR SOLUTION;ORAL	021667-001	Jun 10, 2004		DISCN	Yes	No

Expired US Patents for l-glutamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emmaus Medcl	NUTRESTORE	l-glutamine	FOR SOLUTION;ORAL	021667-001	Jun 10, 2004