ARISTADA Drug Patent Profile
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When do Aristada patents expire, and what generic alternatives are available?
Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. There are seventeen patents protecting this drug.
This drug has one hundred and forty-one patent family members in twenty-eight countries.
The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.
DrugPatentWatch® Generic Entry Outlook for Aristada
Aristada was eligible for patent challenges on October 5, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 19, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for ARISTADA?
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Summary for ARISTADA
International Patents: | 141 |
US Patents: | 13 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 4 |
Patent Applications: | 131 |
Drug Prices: | Drug price information for ARISTADA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARISTADA |
What excipients (inactive ingredients) are in ARISTADA? | ARISTADA excipients list |
DailyMed Link: | ARISTADA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARISTADA
Generic Entry Date for ARISTADA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*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 ARISTADA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Los Angeles | Phase 4 |
Alkermes, Inc. | Phase 4 |
Alkermes, Inc. | Phase 3 |
Pharmacology for ARISTADA
Drug Class | Atypical Antipsychotic |
US Patents and Regulatory Information for ARISTADA
ARISTADA is protected by fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARISTADA is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-003 | Oct 5, 2015 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Alkermes Inc | ARISTADA | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533-004 | Jun 5, 2017 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 ARISTADA
When does loss-of-exclusivity occur for ARISTADA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15231278
Patent: Aripiprazole formulations having increased injection speeds
Estimated Expiration: ⤷ Try for Free
Patent: 20202577
Patent: Aripiprazole formulations having increased injection speeds
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2016021535
Patent: Kit compreendendo formulações de aripiprazol tendo velocidades de injeção aumentadas útil para o tratamento de uma desordem do sistema nervoso central e uso
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 43213
Estimated Expiration: ⤷ Try for Free
China
Patent: 6132415
Estimated Expiration: ⤷ Try for Free
Patent: 0368360
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 19399
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 7517
Estimated Expiration: ⤷ Try for Free
Patent: 5227
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 24110
Estimated Expiration: ⤷ Try for Free
Patent: 96015
Estimated Expiration: ⤷ Try for Free
Patent: 17507992
Estimated Expiration: ⤷ Try for Free
Patent: 19123749
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 16012041
Estimated Expiration: ⤷ Try for Free
Patent: 20010839
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 495
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 3869
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 88233
Estimated Expiration: ⤷ Try for Free
Patent: 16141055
Estimated Expiration: ⤷ Try for Free
Patent: 19114425
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ARISTADA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2015071641 | ⤷ Try for Free | |
New Zealand | 762767 | Aripiprazole formulations having increased injection speeds | ⤷ Try for Free |
Spain | 2885698 | ⤷ Try for Free | |
Japan | 2015063562 | 神経学的および精神的障害の治療のための複素環式化合物 (HETEROCYCLIC COMPOUNDS FOR TREATMENT OF NEUROLOGICAL AND PSYCHOLOGICAL DISORDERS) | ⤷ Try for Free |
Canada | 2937222 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARISTADA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1675573 | 2014C/029 | Belgium | ⤷ Try for Free | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
1675573 | 92427 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: ARIPIPRAZOLE |
1675573 | C300669 | Netherlands | ⤷ Try for Free | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
1675573 | 300669 | Netherlands | ⤷ Try for Free | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
0367141 | SPC/GB04/039 | United Kingdom | ⤷ Try for Free | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ARISTADA
More… ↓