GLEOLAN Drug Patent Profile
✉ Email this page to a colleague
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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for GLEOLAN?
- What are the global sales for GLEOLAN?
- What is Average Wholesale Price for GLEOLAN?
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 |
| Drug Prices: | Drug price information for GLEOLAN |
| What excipients (inactive ingredients) are in GLEOLAN? | GLEOLAN excipients list |
| DailyMed Link: | GLEOLAN at DailyMed |
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 |
US Patents and Regulatory Information for GLEOLAN
GLEOLAN is protected by zero US patents and one FDA Regulatory Exclusivity.
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: ⤷ Sign Up
| 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 | ⤷ 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 |
