Mirtazapine - Generic Drug Details
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What are the generic drug sources for mirtazapine and what is the scope of patent protection?
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, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, 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: | 18 |
NDAs: | 23 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 34 |
Raw Ingredient (Bulk) Api Vendors: | 162 |
Clinical Trials: | 100 |
Patent Applications: | 7,028 |
Formulation / Manufacturing: | see details |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upsher Smith Labs | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076219-001 | Jun 19, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ivax Sub Teva Pharms | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076244-003 | Dec 22, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actavis Labs Fl Inc | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076336-001 | Jun 20, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Prasco | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751-002 | Jan 18, 2023 | 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 |
Expired US Patents for mirtazapine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |