ARIPIPRAZOLE Drug Patent Profile
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Which patents cover Aripiprazole, and what generic alternatives are available?
Aripiprazole is a drug marketed by Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms. and is included in thirty-three NDAs.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aripiprazole
A generic version of ARIPIPRAZOLE was approved as aripiprazole by ALEMBIC on April 28th, 2015.
Summary for ARIPIPRAZOLE
See drug prices for ARIPIPRAZOLE
Recent Clinical Trials for ARIPIPRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | N/A |
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
| First Affiliated Hospital of Chongqing Medical University | Phase 1/Phase 2 |
Pharmacology for ARIPIPRAZOLE
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for ARIPIPRAZOLE
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABILIFY MAINTENA KIT | Extended-release Injectable Suspension | aripiprazole | 300 mg/vial and 400 mg/vial | 202971 | 1 | 2021-12-20 |
| ABILIFY | Oral Solution | aripiprazole | 1 mg/mL | 021713 | 1 | 2007-12-20 |
| ABILIFY | Tablets | aripiprazole | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | 021436 | 8 | 2006-11-15 |
| ABILIFY | Orally Disintegrating Tablets | aripiprazole | 10 mg, 15 mg, 20 mg and 30 mg | 021729 | 1 | 2006-11-15 |
US Patents and Regulatory Information for ARIPIPRAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd V | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 205064-006 | Apr 28, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sciegen Pharms Inc | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 206383-005 | Sep 29, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alkem Labs Ltd | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 207105-005 | Feb 21, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alembic | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 202101-002 | Apr 28, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Orbion Pharms | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 202683-002 | May 23, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for ARIPIPRAZOLE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Limited | Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) | aripiprazole | EMEA/H/C/003803 Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. |
Authorised | yes | no | no | 2015-06-30 | |
| Otsuka Pharmaceutical Netherlands B.V. | Abilify | aripiprazole | EMEA/H/C/000471 Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. |
Authorised | no | no | no | 2004-06-04 | |
| Otsuka Pharmaceutical Netherlands B.V. | Abilify Maintena | aripiprazole | EMEA/H/C/002755 Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. |
Authorised | no | no | no | 2013-11-14 | |
| Accord Healthcare S.L.U. | Aripiprazole Accord | aripiprazole | EMEA/H/C/004021 Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older., |
Authorised | yes | no | no | 2015-11-15 | |
| Zentiva, k.s. | Aripiprazole Zentiva | aripiprazole | EMEA/H/C/003899 Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. |
Authorised | yes | no | no | 2015-06-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
