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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Fuji
Boehringer Ingelheim
Cerilliant
Teva
Federal Trade Commission
Merck
Chubb
UBS

Generated: January 23, 2018

DrugPatentWatch Database Preview

Paroxetine mesylate - Generic Drug Details

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What are the generic sources for paroxetine mesylate and what is the scope of paroxetine mesylate freedom to operate?

Paroxetine mesylate
is the generic ingredient in three branded drugs marketed by Sebela Ireland Ltd, Actavis Labs Fl Inc, and Prinston Inc, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has sixty-three patent family members in thirty-two countries.

There are thirty drug master file entries for paroxetine mesylate. Four suppliers are listed for this compound.
Pharmacology for paroxetine mesylate

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
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Actavis Labs Fl Inc PAROXETINE MESYLATE paroxetine mesylate CAPSULE;ORAL 207139-001 Jun 20, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Prinston Inc PAROXETINE MESYLATE paroxetine mesylate CAPSULE;ORAL 207188-001 Aug 18, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-003 Jul 3, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-003 Jul 3, 2003 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 021299-002 Jul 3, 2003 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-003 Jul 3, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for paroxetine mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,900,327 4-phenylpiperidine compounds ➤ Subscribe
8,859,576 Method of treating thermoregulatory dysfunction with paroxetine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for paroxetine mesylate

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Serving leading biopharmaceutical companies globally:

Teva
Express Scripts
Chinese Patent Office
Harvard Business School
US Department of Justice
Fish and Richardson
Deloitte
Johnson and Johnson
AstraZeneca

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 verifification 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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