ARISTADA INITIO KIT Drug Patent Profile
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Which patents cover Aristada Initio Kit, and what generic alternatives are available?
Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. There are eight patents protecting this drug.
This drug has ninety-eight patent family members in twenty-seven countries.
The generic ingredient in ARISTADA INITIO KIT 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 Initio Kit
Aristada Initio Kit 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 September 8, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ARISTADA INITIO KIT
International Patents: | 98 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
DailyMed Link: | ARISTADA INITIO KIT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARISTADA INITIO KIT
Generic Entry Date for ARISTADA INITIO KIT*:
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 INITIO KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alkermes, Inc. | Phase 4 |
University of California, Los Angeles | Phase 4 |
Alkermes, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ARISTADA INITIO KIT
US Patents and Regulatory Information for ARISTADA INITIO KIT
ARISTADA INITIO KIT is protected by eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARISTADA INITIO KIT is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 INITIO KIT
Aripiprazole prodrug compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole prodrug composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Aripiprazole prodrug composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole prodrug composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Aripiprazole dosing strategy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
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 INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 ARISTADA INITIO KIT
When does loss-of-exclusivity occur for ARISTADA INITIO KIT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15306198
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017002926
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 57762
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6794251
Estimated Expiration: ⤷ Try a Trial
Patent: 2494492
Estimated Expiration: ⤷ Try a Trial
Patent: 2641785
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0190642
Estimated Expiration: ⤷ Try a Trial
Patent: 0211271
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 21594
Estimated Expiration: ⤷ Try a Trial
Patent: 24625
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 43169
Estimated Expiration: ⤷ Try a Trial
Patent: 55711
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0607
Estimated Expiration: ⤷ Try a Trial
Patent: 2079
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 71166
Estimated Expiration: ⤷ Try a Trial
Patent: 26167
Estimated Expiration: ⤷ Try a Trial
Patent: 57830
Estimated Expiration: ⤷ Try a Trial
Patent: 17524021
Estimated Expiration: ⤷ Try a Trial
Patent: 20007316
Estimated Expiration: ⤷ Try a Trial
Patent: 21059604
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 1417
Estimated Expiration: ⤷ Try a Trial
Patent: 17002029
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8914
Estimated Expiration: ⤷ Try a Trial
Patent: 7204
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 05376
Estimated Expiration: ⤷ Try a Trial
Patent: 17108204
Estimated Expiration: ⤷ Try a Trial
Patent: 19134055
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 746
Estimated Expiration: ⤷ Try a Trial
Patent: 232
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 82958
Estimated Expiration: ⤷ Try a Trial
Patent: 08196
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 21270
Estimated Expiration: ⤷ Try a Trial
Patent: 84849
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1905694
Estimated Expiration: ⤷ Try a Trial
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 INITIO KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 201103912 | Prodrugs of NH-acidic compounds | ⤷ Try a Trial |
Japan | 6571166 | ⤷ Try a Trial | |
Russian Federation | 2017108204 | КОМПОЗИЦИИ ПРОЛЕКАРСТВА АРИПИПРАЗОЛА | ⤷ Try a Trial |
Lithuania | 3182958 | ⤷ Try a Trial | |
European Patent Office | 2445502 | COMPOSÉS HÉTÉROCYCLIQUES DESTINÉS AU TRAITEMENT DE TROUBLES NEUROLOGIQUES ET PSYCHOLOGIQUES (HETEROCYCLIC COMPOUNDS FOR THE TREATMENT OF NEUROLOGICAL AND PSYCHOLOGICAL DISORDERS) | ⤷ Try a Trial |
Israel | 250607 | תכשירי פרו-תרופה אריפיפראזול, ושימושים בהם (Aripiprazole prodrug compositions and uses thereof) | ⤷ Try a Trial |
Canada | 3092335 | STRATEGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARISTADA INITIO KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1675573 | 2014C/029 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
1675573 | C300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
0367141 | SPC/GB04/039 | United Kingdom | ⤷ Try a Trial | 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 | 300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
1675573 | 92427 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |