AQNEURSA Drug Patent Profile

Name: AQNEURSA Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Aqneursa, and when can generic versions of Aqneursa launch?

Aqneursa is a drug marketed by Intrabio and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-two patent family members in thirty-one countries.

The generic ingredient in AQNEURSA is levacetylleucine. One supplier is listed for this compound. Additional details are available on the levacetylleucine profile page.

DrugPatentWatch^® Generic Entry Outlook for Aqneursa

Aqneursa will be eligible for patent challenges on September 24, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 24, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for AQNEURSA

International Patents:	72
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,540
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AQNEURSA
What excipients (inactive ingredients) are in AQNEURSA?	AQNEURSA excipients list
DailyMed Link:	AQNEURSA at DailyMed

Drug patent expirations by year for AQNEURSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AQNEURSA

Generic Entry Date for AQNEURSA^: ⤷ Start Trial* 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 NDA: 219132 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 AQNEURSA

Mechanism of Action	Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for AQNEURSA

AQNEURSA is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AQNEURSA is ⤷ Start Trial.

This potential generic entry date is based on TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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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	11,400,067	⤷ 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	12,433,862	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for AQNEURSA

See the table below for patents covering AQNEURSA around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2017308864		⤷ Start Trial
Australia	2023202903		⤷ Start Trial
Australia	2025203479		⤷ Start Trial
Brazil	112019002719		⤷ Start Trial
Canada	3033557		⤷ Start Trial
China	109843275		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AQNEURSA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3482754	CA 2026 00020	Denmark	⤷ Start Trial	PRODUCT NAME: LEVACETYLLEUCIN; REG. NO/DATE: EU/1/25/1928 20260120
3482754	301377	Netherlands	⤷ Start Trial	PRODUCT NAME: LEVACETYLLEUCINE; REGISTRATION NO/DATE: EU/1/25/1928 20260220
3482754	CR 2026 00020	Denmark	⤷ Start Trial	PRODUCT NAME: LEVACETYLLEUCIN; REG. NO/DATE: EU/1/25/1928 20260120
3482754	C20260014	Finland	⤷ Start Trial
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