Aminolevulinic acid hydrochloride - Generic Drug Details
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What are the generic sources for aminolevulinic acid hydrochloride and what is the scope of freedom to operate?
Aminolevulinic acid hydrochloride
is the generic ingredient in three branded drugs marketed by Nxdc, Biofrontera, and Dusa, and is included in three NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aminolevulinic acid hydrochloride has thirty-six patent family members in eighteen countries.
There are five drug master file entries for aminolevulinic acid hydrochloride. Three suppliers are listed for this compound.
Summary for aminolevulinic acid hydrochloride
International Patents: | 36 |
US Patents: | 7 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 99 |
Patent Applications: | 6,457 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aminolevulinic acid hydrochloride |
What excipients (inactive ingredients) are in aminolevulinic acid hydrochloride? | aminolevulinic acid hydrochloride excipients list |
DailyMed Link: | aminolevulinic acid hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aminolevulinic acid hydrochloride
Generic Entry Dates for aminolevulinic acid hydrochloride*:
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 Dosage:
FOR SOLUTION;ORAL |
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL |
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
GEL;TOPICAL |
*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 aminolevulinic acid hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1/Phase 2 |
University of Zurich | Early Phase 1 |
Westfälische Wilhelms-Universität Münster | Phase 1/Phase 2 |
Pharmacology for aminolevulinic acid hydrochloride
Drug Class | Optical Imaging Agent Porphyrin Precursor |
Mechanism of Action | Fluorescence Contrast Activity |
Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride
US Patents and Regulatory Information for aminolevulinic acid hydrochloride
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 | ||||
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 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 |
Expired US Patents for aminolevulinic acid hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aminolevulinic acid hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2009006088 | NANOEMULSION. (NANOEMULSION.) | ⤷ Try a Trial |
Argentina | 064659 | NANOEMULSION | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2008077641 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated 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.