Last Updated: September 24, 2026

LEVACETYLLEUCINE - Generic Drug Details


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What are the generic drug sources for levacetylleucine and what is the scope of patent protection?

Levacetylleucine is the generic ingredient in one branded drug marketed by Intrabio and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for LEVACETYLLEUCINE
International Patents:77
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Patent Applications: 2,517
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for LEVACETYLLEUCINE
What excipients (inactive ingredients) are in LEVACETYLLEUCINE?LEVACETYLLEUCINE excipients list
DailyMed Link:LEVACETYLLEUCINE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEVACETYLLEUCINE
Generic Entry Date for LEVACETYLLEUCINE*:

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Constraining patent/regulatory exclusivity:

TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG

Dosage:

FOR SUSPENSION;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.

Pharmacology for LEVACETYLLEUCINE
Mechanism of ActionBile Salt Export Pump Inhibitors
Breast Cancer Resistance Protein Inhibitors
Organic Anion Transporter 1 Inhibitors
Organic Anion Transporter 3 Inhibitors
P-Glycoprotein Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for LEVACETYLLEUCINE
N07XX Other nervous system drugs
N07X OTHER NERVOUS SYSTEM DRUGS
N07 OTHER NERVOUS SYSTEM DRUGS
N Nervous system

US Patents and Regulatory Information for LEVACETYLLEUCINE

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes 12,433,862 ⤷  Start Trial ⤷  Start Trial
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes 12,433,863 ⤷  Start Trial ⤷  Start Trial
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Intrabio AQNEURSA levacetylleucine FOR SUSPENSION;ORAL 219132-001 Sep 24, 2024 RX Yes Yes 11,400,067 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Supplementary Protection Certificates for LEVACETYLLEUCINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3482754 50018/2026 Austria ⤷  Start Trial PRODUCT NAME: LEVACETYLLEUCIN; REGISTRATION NO/DATE: EU/1/25/1928 (MITTEILUNG) 20260120
3482754 301377 Netherlands ⤷  Start Trial PRODUCT NAME: LEVACETYLLEUCINE; REGISTRATION NO/DATE: EU/1/25/1928 20260220
3482754 C20260014 Finland ⤷  Start Trial
3482754 CR 2026 00020 Denmark ⤷  Start Trial PRODUCT NAME: LEVACETYLLEUCIN; REG. NO/DATE: EU/1/25/1928 20260120
3482754 LUC50049 Luxembourg ⤷  Start Trial PRODUCT NAME: LEVACETYLLEUCINE; AUTHORISATION NUMBER AND DATE: EU/1/25/1928 20260120
3482754 PA2026517 Lithuania ⤷  Start Trial PRODUCT NAME: LEVACETILLEUCINAS; REGISTRATION NO/DATE: EU/1/25/1928 20260119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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