MIRTAZAPINE Drug Patent Profile
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Which patents cover Mirtazapine, 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, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, 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-five 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.
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Questions you can ask:
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Summary for MIRTAZAPINE
US Patents: | 0 |
Applicants: | 17 |
NDAs: | 21 |
Finished Product Suppliers / Packagers: | 34 |
Raw Ingredient (Bulk) Api Vendors: | 162 |
Clinical Trials: | 100 |
Patent Applications: | 5,189 |
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 |
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Aurobindo | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076921-002 | Oct 22, 2004 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Prasco | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751-003 | Jan 18, 2023 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 |
MIRTAZAPINE Market Analysis and Financial Projection Experimental
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