OLANZAPINE Drug Patent Profile
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When do Olanzapine patents expire, and when can generic versions of Olanzapine launch?
Olanzapine is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Endo Operations, and Epic Pharma Llc. and is included in forty-six NDAs.
The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
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Summary for OLANZAPINE
| US Patents: | 0 |
| Applicants: | 33 |
| NDAs: | 46 |
| Finished Product Suppliers / Packagers: | 45 |
| Raw Ingredient (Bulk) Api Vendors: | 147 |
| Clinical Trials: | 503 |
| Patent Applications: | 4,698 |
| Drug Prices: | Drug price information for OLANZAPINE |
| Drug Sales Revenues: | Drug sales revenues for OLANZAPINE |
| DailyMed Link: | OLANZAPINE at DailyMed |
See drug prices for OLANZAPINE
Recent Clinical Trials for OLANZAPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Minerva Neurosciences | Phase 1 |
| Simon Williamson Clinic | Phase 2 |
| Helsinn Healthcare SA | Phase 2 |
Pharmacology for OLANZAPINE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for OLANZAPINE
US Patents and Regulatory Information for OLANZAPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | OLANZAPINE | olanzapine | TABLET;ORAL | 206711-004 | Aug 30, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecular | OLANZAPINE | olanzapine | TABLET;ORAL | 203333-003 | Mar 15, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203044-001 | Feb 20, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hec Pharm | OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 208146-004 | Jul 2, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sunshine | OLANZAPINE | olanzapine | TABLET;ORAL | 206238-006 | Nov 19, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 OLANZAPINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly Nederland B.V. | Zyprexa Velotab | olanzapine | EMEA/H/C/000287 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | no | no | no | 2000-02-03 | |
| Eli Lilly Nederland B.V. | Zypadhera | olanzapine | EMEA/H/C/000890 Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. |
Authorised | no | no | no | 2008-11-19 | |
| Eli Lilly Nederland B.V. | Zyprexa | olanzapine | EMEA/H/C/000115 Coated tabletsAdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate. |
Authorised | no | no | no | 1996-09-27 | |
| Krka | Zalasta | olanzapine | EMEA/H/C/000792 Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | yes | no | no | 2007-09-27 | |
| Mylan Pharmaceuticals Limited | Olanzapine Mylan | olanzapine | EMEA/H/C/000961 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | yes | no | no | 2008-10-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
