ENDARI Drug Patent Profile
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Which patents cover Endari, and what generic alternatives are available?
Endari is a drug marketed by Emmaus Medcl and is included in one NDA.
The generic ingredient in ENDARI is l-glutamine. There are forty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the l-glutamine profile page.
Summary for ENDARI
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 188 |
| Clinical Trials: | 3 |
| Patent Applications: | 194 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ENDARI |
| What excipients (inactive ingredients) are in ENDARI? | ENDARI excipients list |
| DailyMed Link: | ENDARI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ENDARI
Generic Entry Date for ENDARI*:
Constraining patent/regulatory exclusivity:
TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER. NDA:
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 ENDARI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jun Gong, MD | Phase 1 |
| Emmaus Medical, Inc. | Phase 1 |
| Emmaus Medical, Inc. | Phase 4 |
Pharmacology for ENDARI
| Drug Class | Amino Acid |
US Patents and Regulatory Information for ENDARI
ENDARI is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ENDARI is ⤷ Try a Trial.
This potential generic entry date is based on TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER..
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting ENDARI
TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER.
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
