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
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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
*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 |
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 ⤷ 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 INITIO KIT
Aripiprazole prodrug compositions
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
Aripiprazole prodrug composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Aripiprazole prodrug composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Aripiprazole prodrug composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Aripiprazole dosing strategy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alkermes Inc | ARISTADA INITIO KIT | aripiprazole lauroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830-001 | Jun 29, 2018 | 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 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
Patent: Aripiprazole prodrug compositions
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017002926
Patent: composições e método para aprimorar o perfil de liberação farmacocinético inicial in vivo
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 57762
Patent: COMPOSITIONS DE PROMEDICAMENT D'ARIPIPRAZOLE (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 6794251
Patent: 阿立哌唑前体药物组合物 (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 2494492
Patent: 阿立哌唑前体药物组合物 (Aripiprazole prodrug compositions)
Estimated Expiration: ⤷ Sign Up
Patent: 2641785
Patent: 阿立哌唑前体药物组合物 (Aripiprazole prodrug compositions)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0190642
Estimated Expiration: ⤷ Sign Up
Patent: 0211271
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 21594
Estimated Expiration: ⤷ Sign Up
Patent: 24625
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 82958
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 82958
Patent: COMPOSITION DE PROMÉDICAMENT D'ARIPIPRAZOLE (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Patent: COMPOSITION DE PROMÉDICAMENT D'ARIPIPRAZOLE (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 43169
Estimated Expiration: ⤷ Sign Up
Patent: 55711
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0607
Patent: תכשירי פרו-תרופה אריפיפראזול, ושימושים בהם (Aripiprazole prodrug compositions and uses thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 2079
Patent: תכשירי פרותרופה אריפיפראזול, ושימושים בהם (Aripiprazole prodrug compositions and uses thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 71166
Estimated Expiration: ⤷ Sign Up
Patent: 26167
Estimated Expiration: ⤷ Sign Up
Patent: 57830
Estimated Expiration: ⤷ Sign Up
Patent: 17524021
Patent: アリピプラゾールプロドラッグ組成物
Estimated Expiration: ⤷ Sign Up
Patent: 20007316
Patent: アリピプラゾールプロドラッグ組成物 (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 21059604
Patent: アリピプラゾールプロドラッグ組成物 (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 82958
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1417
Patent: COMPOSICIONES DE PROFARMACOS DE ARIPIPRAZOL. (ARIPIPRAZOLE PRODRUG COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 17002029
Patent: COMPOSICIONES DE PROFARMACOS DE ARIPIPRAZOL. (ARIPIPRAZOLE PRODRUG COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8914
Patent: Aripiprazole prodrug compositions
Estimated Expiration: ⤷ Sign Up
Patent: 7204
Patent: Aripiprazole prodrug compositions
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 82958
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 82958
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 05376
Patent: КОМПОЗИЦИИ ПРОЛЕКАРСТВА АРИПИПРАЗОЛА (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 17108204
Patent: КОМПОЗИЦИИ ПРОЛЕКАРСТВА АРИПИПРАЗОЛА
Estimated Expiration: ⤷ Sign Up
Patent: 19134055
Patent: КОМПОЗИЦИИ ПРОЛЕКАРСТВА АРИПИПРАЗОЛА
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 746
Patent: KOMPOZICIJE PROLEKA ARIPIPRAZOLA (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 232
Patent: KOMPOZICIJE PROLEKA ARIPIPRAZOLA (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 82958
Estimated Expiration: ⤷ Sign Up
Patent: 08196
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 21270
Estimated Expiration: ⤷ Sign Up
Patent: 84849
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1905694
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 INITIO KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2010151689 | ⤷ Sign Up | |
| Russian Federation | 2017108204 | КОМПОЗИЦИИ ПРОЛЕКАРСТВА АРИПИПРАЗОЛА | ⤷ Sign Up |
| Japan | 2020007316 | アリピプラゾールプロドラッグ組成物 (ARIPIPRAZOLE PRODRUG COMPOSITIONS) | ⤷ Sign Up |
| Cyprus | 1120054 | ⤷ Sign Up | |
| Japan | 2017524021 | アリピプラゾールプロドラッグ組成物 | ⤷ Sign Up |
| >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 | 92427 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE |
| 1675573 | 2014C/029 | Belgium | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 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 |
| 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 |
| >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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