REMERON SOLTAB Drug Patent Profile
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When do Remeron Soltab patents expire, and when can generic versions of Remeron Soltab launch?
Remeron Soltab is a drug marketed by Organon Usa Organon and is included in one NDA.
The generic ingredient in REMERON SOLTAB 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 Remeron Soltab
A generic version of REMERON SOLTAB was approved as mirtazapine by TEVA on January 24th, 2003.
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Summary for REMERON SOLTAB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 2 |
| Patent Applications: | 5,299 |
| Drug Prices: | Drug price information for REMERON SOLTAB |
| DailyMed Link: | REMERON SOLTAB at DailyMed |
Recent Clinical Trials for REMERON SOLTAB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Teva Pharmaceuticals USA | Phase 1 |
US Patents and Regulatory Information for REMERON SOLTAB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | AB | RX | 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 SOLTAB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for REMERON SOLTAB
| 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 SOLTAB
See the table below for patents covering REMERON SOLTAB around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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.) | ⤷ Sign Up |
| Norway | 313177 | ⤷ Sign Up | |
| Germany | 69710390 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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