Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Cipla
Mallinckrodt
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Argus Health

Generated: August 24, 2019

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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 four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has eighty patent family members in thirty-five countries.

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

Pharmacology for paroxetine mesylate
Synonyms for paroxetine mesylate
(3S,4R)-3-((Benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine methanesulfonate
217797-14-3
AKOS027321054
Brisdelle
Brisdelle (TN)
CHEMBL1200609
D05375
LDMP
M711N184JE
Paroxetine Mesilate
Paroxetine mesylate (USAN)
Paroxetine Mesylate [USAN]
Paroxetine methanesulphonate
Pexeva
Pexeva (TN)
POT.mes
SCHEMBL143905
SHIJTGJXUHTGGZ-RVXRQPKJSA-N
UNII-M711N184JE

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
Actavis Labs Fl Inc PAROXETINE MESYLATE paroxetine mesylate CAPSULE;ORAL 207139-001 Jun 20, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
>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 021299-004 Jul 3, 2003 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Express Scripts
Medtronic
Fuji
Federal Trade Commission
QuintilesIMS

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.