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:
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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: | 128 |
| 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
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ARISTADA
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Pharmaceutical compositions comprising sorbitan esters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
Pharmaceutical compositions having improved storage stability
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole dosing strategy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Pharmaceutical compositions comprising sorbitan esters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Pharmaceutical compositions having improved storage stability
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
Aripiprazole formulations having increased injection speeds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | 207533-004 | Jun 5, 2017 | 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 | |||
| >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: ⤷ Sign Up
Patent: 20202577
Patent: Aripiprazole formulations having increased injection speeds
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Canada
Patent: 43213
Patent: FORMULATIONS D'ARIPIPRAZOLE PRESENTANT DES VITESSES D'INJECTION PLUS ELEVEES (ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 6132415
Patent: 具有增加的注射速度的阿立哌唑制剂 (Aripiprazole formulations having increased injection speeds)
Estimated Expiration: ⤷ Sign Up
Patent: 0368360
Patent: 具有增加的注射速度的阿立哌唑制剂 (Aripiprazole formulations having increased injection speeds)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19399
Patent: FORMULATIONS D'ARIPIPRAZOLE PRÉSENTANT DES VITESSES D'INJECTION PLUS ÉLEVÉES (ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7517
Patent: פורמולציות של קדם תרופה של אריפיפרזול בעלות זמני הזרקה מוגברים (Aripiprazole formulations having increased injection speeds)
Estimated Expiration: ⤷ Sign Up
Patent: 5227
Patent: פורמולציות של קדם-תרופה של אריפיפרזול בעלות זמני הזרקה מוגברים (Aripiprazole prodrug formulations having increased injection speeds)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 24110
Estimated Expiration: ⤷ Sign Up
Patent: 96015
Estimated Expiration: ⤷ Sign Up
Patent: 17507992
Patent: 注射速度が増大したアリピプラゾール調合物
Estimated Expiration: ⤷ Sign Up
Patent: 19123749
Patent: 注射速度が増大したアリピプラゾール調合物 (ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16012041
Patent: FORMULACIONES DE ARIPIPRAZOL QUE TIENEN MAYORES VELOCIDADES DE INYECCION. (ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS.)
Estimated Expiration: ⤷ Sign Up
Patent: 20010839
Patent: FORMULACIONES DE ARIPIPRAZOL QUE TIENEN MAYORES VELOCIDADES DE INYECCION. (ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 495
Patent: FORMULATIONS D'ARIPIPRAZOLE PRÉSENTANT DES VITESSES D'INJECTION PLUS ÉLEVÉES
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3869
Patent: Aripiprazole formulations having increased injection speeds
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 88233
Patent: ПРЕПАРАТЫ АРИПИПРАЗОЛА, ИМЕЮЩИЕ ПОВЫШЕННЫЕ СКОРОСТИ ВПРЫСКА (ARIPIPRAZOLE PREPARATIONS HAVING HIGH INJECTION RATES)
Estimated Expiration: ⤷ Sign Up
Patent: 16141055
Patent: ПРЕПАРАТЫ АРИПИПРАЗОЛА, ИМЕЮЩИЕ ПОВЫШЕННЫЕ СКОРОСТИ ВПРЫСКА
Estimated Expiration: ⤷ Sign Up
Patent: 19114425
Patent: ПРЕПАРАТЫ АРИПИПРАЗОЛА, ИМЕЮЩИЕ ПОВЫШЕННЫЕ СКОРОСТИ ВПРЫСКА
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| European Patent Office | 2685979 | COMPOSITIONS PHARMACEUTIQUES INJECTABLES COMPRENANT UN AGENT ANTIPSYCHOTIQUE INSOLUBLE DANS L'EAU, DU LAURATE DE SORBITAN ET DU POLYSORBATE 20 (INJECTABLE PHARMACEUTICAL COMPOSITIONS COMPRISING A WATER-INSOLUBLE ANTI-PSYCHOTIC, SORBITAN LAURATE AND POLYSORBATE 20) | ⤷ Sign Up |
| Saudi Arabia | 110310539 | مركبات NH-الحمضية (NH-ACIDIC COMPOUNDS) | ⤷ Sign Up |
| New Zealand | 748572 | Pharmaceutical compositions having improved storage stability | ⤷ Sign Up |
| Canada | 3092335 | STRATEGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARISTADA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | 92427 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE |
| 0367141 | SPC/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 |
| 1675573 | C300669 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 300669 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| >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. 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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