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Last Updated: January 30, 2023

Aripiprazole lauroxil - Generic Drug Details


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What are the generic sources for aripiprazole lauroxil and what is the scope of freedom to operate?

Aripiprazole lauroxil is the generic ingredient in two branded drugs marketed by Alkermes Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and sixty-seven patent family members in twenty-nine countries.

There are three drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.

Summary for aripiprazole lauroxil
Recent Clinical Trials for aripiprazole lauroxil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, Los AngelesPhase 4
Alkermes, Inc.Phase 4
Alkermes, Inc.Phase 1

See all aripiprazole lauroxil clinical trials

US Patents and Regulatory Information for aripiprazole lauroxil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 aripiprazole lauroxil

Country Patent Number Title Estimated Expiration
China 110368360 具有增加的注射速度的阿立哌唑制剂 (Aripiprazole formulations having increased injection speeds) See Plans and Pricing
Australia 2019230014 Aripiprazole dosing strategy See Plans and Pricing
Australia 2012231160 Pharmaceutical compositions comprising sorbitan esters See Plans and Pricing
Spain 2721270 See Plans and Pricing
Canada 3092335 STRATEGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY) See Plans and Pricing
New Zealand 713984 Pharmaceutical compositions comprising sorbitan esters See Plans and Pricing
Spain 2639065 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aripiprazole lauroxil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 SPC/GB04/039 United Kingdom See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573 C300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 2014C/029 Belgium See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 92427 Luxembourg See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
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McKesson

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