MIRTAZAPINE Drug Patent Profile
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When do Mirtazapine patents expire, and what generic alternatives are available?
Mirtazapine is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Aiping Pharm Inc, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs. and is included in twenty-one NDAs.
The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mirtazapine
A generic version of MIRTAZAPINE was approved as mirtazapine by TEVA on January 24th, 2003.
Summary for MIRTAZAPINE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 100 |
| Patent Applications: | 4,416 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for MIRTAZAPINE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076122-001 | Jun 19, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex Inc | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 077666-002 | Aug 22, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Prasco | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751-003 | Jan 18, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076119-003 | Jun 19, 2003 | 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 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 |
