✉ Email this page to a colleague
« Back to Dashboard
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ENDARI
*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
|Jun Gong, MD||Phase 1|
|Emmaus Medical, Inc.||Phase 1|
|Emmaus Medical, Inc.||Phase 4|
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 See Plans and Pricing.
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: See Plans and Pricing
|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||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|