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L-glutamine - Generic Drug Details
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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.
Summary for l-glutamine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 45 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 155 |
| Clinical Trials: | 160 |
| Patent Applications: | 2,081 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | l-glutamine at DailyMed |
Recent Clinical Trials for l-glutamine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jun Gong, MD | Phase 1 |
| Emmaus Medical, Inc. | Phase 1 |
| National Cardiovascular Center Harapan Kita Hospital Indonesia | Phase 3 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Emmaus Medcl | ENDARI | l-glutamine | FOR SOLUTION;ORAL | 208587-001 | Jul 7, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Emmaus Medcl | NUTRESTORE | l-glutamine | FOR SOLUTION;ORAL | 021667-001 | Jun 10, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
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