paroxetine mesylate - Profile
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What are the generic sources for paroxetine mesylate and what is the scope of patent protection?
Paroxetine mesylate
is the generic ingredient in three branded drugs marketed by Legacy Pharma, Actavis Labs Fl Inc, Prinston Inc, and Sebela Ireland Ltd, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Paroxetine mesylate has forty-four patent family members in twenty-six countries.
Summary for paroxetine mesylate
| International Patents: | 44 |
| US Patents: | 3 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for paroxetine mesylate |
Paragraph IV (Patent) Challenges for PAROXETINE MESYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRISDELLE | Capsules | paroxetine mesylate | 7.5 mg | 204516 | 1 | 2014-04-07 |
US Patents and Regulatory Information for paroxetine mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Legacy Pharma | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | 8,946,251 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | |
| Legacy Pharma | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | 9,393,237 | ⤷ Start Trial | ⤷ Start Trial | |||
| Legacy Pharma | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | AB | RX | Yes | Yes | 8,658,663 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | |
| Actavis Labs Fl Inc | PAROXETINE MESYLATE | paroxetine mesylate | CAPSULE;ORAL | 207139-001 | Jun 20, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Prinston Inc | PAROXETINE MESYLATE | paroxetine mesylate | CAPSULE;ORAL | 207188-001 | Aug 18, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 paroxetine mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299-003 | Jul 3, 2003 | 6,703,408 | ⤷ Start Trial |
| Sebela Ireland Ltd | PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299-002 | Jul 3, 2003 | 7,598,271 | ⤷ Start Trial |
| Legacy Pharma | BRISDELLE | paroxetine mesylate | CAPSULE;ORAL | 204516-001 | Jun 28, 2013 | 5,874,447 | ⤷ Start Trial |
| Sebela Ireland Ltd | PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299-004 | Jul 3, 2003 | 5,874,447 | ⤷ Start Trial |
| Sebela Ireland Ltd | PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299-003 | Jul 3, 2003 | 5,874,447 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paroxetine mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2007282065 | Method of treating thermoregulatory disfunction with paroxetine | ⤷ Start Trial |
| Brazil | PI0715087 | MÉTODO DE TRATAMENTO DE DISFUNÇÃO TERMOREGULATÓRIA COM PAROXETINA | ⤷ Start Trial |
| Canada | 2659577 | METHODE POUR TRAITER UN DYSFONCTIONNEMENT DE THERMOREGULATION AVEC DE LA PAROXETINE (METHOD OF TREATING THERMOREGULATORY DISFUNCTION WITH PAROXETINE) | ⤷ Start Trial |
| China | 101505759 | Method of treating thermoregulatory disfunction with paroxetine | ⤷ Start Trial |
| Cyprus | 1120867 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
