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.
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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: | 4,353 |
| 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 |
|---|---|
| Northwestern University | Phase 1/Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 |
| Ain Shams University | Early Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | DISCN | Yes | 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 |
Expired US Patents for REMERON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Austria | 213159 | ⤷ Sign Up | |
| New Zealand | 328113 | PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI'S) | ⤷ Sign Up |
| Czech Republic | 9701870 | ⤷ Sign Up | |
| Hong Kong | 1006081 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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