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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Julphar
Farmers Insurance
Mallinckrodt
Argus Health
Queensland Health
Harvard Business School
US Army
Dow
Cantor Fitzgerald

Generated: February 25, 2018

DrugPatentWatch Database Preview

Aripiprazole lauroxil - Generic Drug Details

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

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

Aripiprazole lauroxil has seventy-four patent family members in twenty-five countries.

There are forty-five drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.
Summary for aripiprazole lauroxil

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for aripiprazole lauroxil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,351,976 Pharmaceutical compositions comprising sorbitan esters ➤ Sign Up
8,686,009 Prodrugs of NH-acidic compounds ➤ Sign Up
9,102,618 Prodrugs of NH-acidic compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for aripiprazole lauroxil

Country Document Number Estimated Expiration
Poland 2685979 ➤ Sign Up
Denmark 2445502 ➤ Sign Up
Canada 2766088 ➤ Sign Up
Australia 2012231160 ➤ Sign Up
Japan 2016172742 ➤ Sign Up
Denmark 2685979 ➤ Sign Up
Croatia P20171415 ➤ Sign Up
Portugal 2445502 ➤ Sign Up
Japan 2015071641 ➤ Sign Up
Japan 5733841 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for aripiprazole lauroxil

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/039 United Kingdom ➤ Sign Up 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
0669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
427 Luxembourg ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE
00669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Teva
Julphar
QuintilesIMS
Dow
Colorcon
Johnson and Johnson
Citi

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 verifification 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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