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Last Updated: June 18, 2024

L-glutamine - Generic Drug Details

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What are the generic sources for l-glutamine and what is the scope of freedom to operate?

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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for l-glutamine
Generic Entry Date for l-glutamine*:
Constraining patent/regulatory exclusivity:

*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

University of New MexicoPhase 4
Anahuac UniversityN/A
David J. CangemiPhase 1/Phase 2

See all l-glutamine clinical trials

Generic filers with tentative approvals for L-GLUTAMINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5GPOWDER;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 ClassAmino 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Emmaus Medcl NUTRESTORE l-glutamine FOR SOLUTION;ORAL 021667-001 Jun 10, 2004 DISCN Yes No ⤷  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

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