Patent Family
|
paroxetine (product,
mesilate, 1998)
|
Trade Name(s)
|
CASBOL
SEROXAT
AROPAX
PAXIL
TAGONIS
FROSINOR
DEROXAT
SEREUPIN
MOTIVAN
|
Generic Name(s)
|
paroxetine (INN)
paroxetine hydrochloride
(INN)
paroxetine mesylate (USAN)
|
Lab Code(s)
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FR 7051
BRL 29060
BRL 29060A
SI 211103
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CAS Number
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61869-08-7 paroxetine
110429-35-1 paroxetine
hydrochloride hemihydrate (1:1:0.5)
78246-49-8 paroxetine
hydrochloride (1:1)
121368-57-8 paroxetine
hydrobromide (1:1)
64006-44-6 paroxetine maleate
(1:1)
217797-14-3 paroxetine
mesylate (1:1)
63952-24-9 replaced by
61869-08-7
172501-13-2 replaced by
78246-49-8
217797-12-1 replaced by
64006-44-6
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Chemical Name
|
(3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine
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Class Description
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SSRI antidepressants (N6A4)
Tranquillisers (N5C)
|
Indication
|
depression
obsessive compulsive disorder
anxiety
panic disorder
|
Action
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5HT reuptake inhibitor
|
Latest Phase
|
Marketed
|
Company
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GlaxoSmithKline, UK
|
Patentee
|
SmithKline Beecham, UK
|
Patent Country
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USA
|
Priority Details
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02 Jul 1998 : UK, 14316
06 Oct 1998 : UK, 21732
10 Feb 1999 : UK, 2935
22 Jun 1999 : UK, 14601
23 Jun 1999 : UK, 14709
23 Jun 1999 : UK, 14712
28 Jun 1999 : UK, 15096
19 Nov 1999 : UK, 27498
19 Nov 1999 : UK, 27501
03 Dec 1999 : UK, 28693
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Patent Number
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6063927
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Patent Date
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16 May 2000
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Patent Type
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Process
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Filing Date
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23 Apr 1999
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Est. Expiry Date
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23 Oct 2019
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Expiry Comment
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Extended
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Country Comment
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US 6063927 claims paroxetine
mesilate in crystalline form and claims paroxetine hydrochloride
formed by reacting this with hydrochloric acid.Pediatric
exclusivity of 6 months has been granted in the USA for US
6063927. The new expiry date is 23 October 2019 from 23 April
2019.US 6063927 was quoted by the FDA Orange Book as relating to
the PAXIL 10 mg, 20 mg, 30 mg and 40 mg oral tablet formulations,
the PAXIL CR 12.5 mg, 25 mg a nd 37.5 mg oral extended release
tablet formulations and the PAXIL 10 mg/5 ml oral suspension
formulation of paroxetine hydrochloride equivalent to paroxetine
base.All of these formulations have since been delisted from the
FDA Orange Book.US marketing exclusivity for the PAXIL oral
suspension for the treatment of social anxiety disorder expired on
17 May 2002.US marketing exclusivities for the PAXIL extended
release tablet formulations expire on 16 February 2002. US
marketing exclusivities for the PAXIL oral tablet formulations
expired on 17 May 2002 for the treatment of social anxiety
disorder and on 13 April 2004 for the treatment of generalised
anxiety disorder.
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General Comment
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The patent family here is
quite complex with 10 inter-related priorities and give rise to 4
PCT applications:WO 00/1692 which quotes UK priority 14316 and
claims paroxetine acid salts where the acid is from a defined list
of several thousand named acids. The salts claimed can be
non-crystalline or crystalline. Also claimed is the use of each
salt as an alternative to the currently marketed hydrochloride or
as an intermediate in the preparation of the hydrochloride.WO
00/1694 which quotes UK priorities 14316, 21732 and 14601 and has
specific product claims to paroxetine mesilate, in crystalline or
non-crystalline form. The preparation of paroxetine hydrochloride
from paroxetine mesilate is also claimed.WO 00/78290 which quotes
UK priorities 14601, 14712, 27498 and 28693 claims compositions of
paroxetine salts which are more water soluble than paroxetine
hydrochloride hemihydrate. Compositions of paroxetine mesilate are
specifically claimed.WO 00/78291 which quotes UK priorities 14601,
14709 and 27501 and claims compositions of paroxetine mesilate.The
patent family listed here relates to the PAXIL and PAXIL CR
formulations of paroxetine.Last reviewed: June 2009
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Paxil Patent 6063927 With Pediatric Extention
For more information Click Here