GLEOLAN Drug Patent Profile
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When do Gleolan patents expire, and when can generic versions of Gleolan launch?
Gleolan is a drug marketed by Nxdc and is included in one NDA.
The generic ingredient in GLEOLAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for GLEOLAN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 3 |
Patent Applications: | 271 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for GLEOLAN |
What excipients (inactive ingredients) are in GLEOLAN? | GLEOLAN excipients list |
DailyMed Link: | GLEOLAN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GLEOLAN
Generic Entry Date for GLEOLAN*:
Constraining patent/regulatory exclusivity:
OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY 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 GLEOLAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alpheus Medical, Inc. | Phase 1 |
NX Development Corp | Phase 3 |
Pharmacology for GLEOLAN
Drug Class | Optical Imaging Agent Porphyrin Precursor |
Mechanism of Action | Fluorescence Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GLEOLAN
US Patents and Regulatory Information for GLEOLAN
GLEOLAN is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GLEOLAN is ⤷ Try a Trial.
This potential generic entry date is based on OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY.
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 GLEOLAN
OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nxdc | GLEOLAN | aminolevulinic acid hydrochloride | FOR SOLUTION;ORAL | 208630-001 | Jun 6, 2017 | RX | Yes | Yes | ⤷ 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 |