REMERON Drug Patent Profile
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Which patents cover Remeron, and what generic alternatives are available?
Remeron is a drug marketed by Organon and Organon Usa Organon and is included in two NDAs.
The generic ingredient in REMERON 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 Remeron
A generic version of REMERON was approved as mirtazapine by TEVA on January 24th, 2003.
Summary for REMERON
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 162 |
Clinical Trials: | 39 |
Patent Applications: | 5,360 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for REMERON |
What excipients (inactive ingredients) are in REMERON? | REMERON excipients list |
DailyMed Link: | REMERON at DailyMed |
Recent Clinical Trials for REMERON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 |
Northwestern University | Phase 1/Phase 2 |
Ain Shams University | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for REMERON
US Patents and Regulatory Information for REMERON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | AB | RX | Yes | 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 REMERON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for REMERON
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 |
International Patents for REMERON
See the table below for patents covering REMERON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 320628 | ⤷ Try a Trial | |
Singapore | 60073 | Pharmaceutical composition comprising mirtazapine and one or more selective serotonin reuptake inhibitors | ⤷ Try a Trial |
Mexico | 9704579 | COMPOSICION FARMACEUTICA QUE COMPRENDE MIRTAZAPINA Y UNO O MAS INHIBIDORES SELECTIVOS DE REABSORCION DE SEROTONINA. (PHARMACEUTICAL COMPOSITION COMPRISING MYRTAZPINE AND ONE OR MORE SEROTONINE SELECTIVE REABSORPTION INHIBITORS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |