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.
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 |
What excipients (inactive ingredients) are in l-glutamine? | l-glutamine excipients list |
DailyMed Link: | l-glutamine at DailyMed |
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 |
Generic filers with tentative approvals for L-GLUTAMINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 | NUTRESTORE | l-glutamine | FOR SOLUTION;ORAL | 021667-001 | Jun 10, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Emmaus Medcl | ENDARI | l-glutamine | FOR SOLUTION;ORAL | 208587-001 | Jul 7, 2017 | RX | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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