MIRTAZAPINE - Generic Drug Details
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What are the generic drug sources for mirtazapine and what is the scope of freedom to operate?
Mirtazapine
is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Organon Usa Organon, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, Watson Labs, and Organon, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for mirtazapine. Thirty-four suppliers are listed for this compound.
Summary for MIRTAZAPINE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 19 |
| NDAs: | 23 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 100 |
| Patent Applications: | 6,982 |
| Drug Prices: | Drug price trends for MIRTAZAPINE |
| Drug Sales Revenues: | Drug sales revenues for MIRTAZAPINE |
| What excipients (inactive ingredients) are in MIRTAZAPINE? | MIRTAZAPINE excipients list |
| DailyMed Link: | MIRTAZAPINE at DailyMed |
Recent Clinical Trials for MIRTAZAPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Quebec Researchnetwork on aging | Phase 1 |
| Centre hospitalier de l'Université de Montréal (CHUM) | Phase 1 |
| University of Toronto | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for MIRTAZAPINE
US Patents and Regulatory Information for MIRTAZAPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 076901-002 | Jun 28, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Square Pharms | MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 205798-001 | Jun 1, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 077666-003 | Aug 22, 2007 | AB | RX | 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 |
Expired US Patents for MIRTAZAPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MIRTAZAPINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Dechra Regulatory B.V. | Mirataz | mirtazapine | EMEA/V/C/004733 For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. |
Authorised | no | no | no | 2019-12-10 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
