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-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.
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Questions you can ask:
- What is the 5 year forecast for MIRTAZAPINE?
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- What is Average Wholesale Price for MIRTAZAPINE?
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: | 4,352 |
| 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 |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | Phase 1 |
| Quebec Researchnetwork on aging | Phase 1 |
| Pakistan Institute of Living and Learning | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076921-002 | Oct 22, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prasco | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751-003 | Jan 18, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076119-003 | Jun 19, 2003 | 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 |
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 |
