(12) United States Patent
`US 9,393,208 B2
`(10) Patent N0.:
`
`Ault et al.
`(45) Date of Patent:
`*Jul. 19, 2016
`
`USOO9393208B2
`
`.
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`(Continued)
`
`4,726,951 A
`,
`3
`,
`2133323 2
`4,758,579 A
`4,766,117 A
`4,786,505 A
`4,853,230 A
`4,865,847 A
`4,948,581 A
`g’ggg’ggg :
`5:035:899 A
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`5,043,358 A
`5,051,262 A
`5,093,132 A
`5,204,118 A
`5,260,333 A
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`
`gfiég’igg 2
`5:514:663 A
`5,601,843 A
`5,631,022 A
`5,643,960 A
`5,667,802 A
`5,679,376 A
`5,686,105 A
`5,690,960 A
`5,702,723 A
`5,714,504 A
`5,716,648 A
`5,750,531 A
`5,817,338 A
`5,817,340 A
`5,840,737 A
`5,872,145 A
`5,877,192 2
`5,900,424
`5,955,451
`6,013,281
`6,025,395
`
`AAA
`
`FOREIGN PATENT DOCUMENTS
`
`AU
`CA
`
`2006235929
`2139653
`
`11/2006
`7/2001
`
`(Continued)
`OTHER PUBLICATIONS
`
`“A 12 month, phase 3, open-label, multi-center study to evaluate the
`long-term safety of PN 400," ClinicalTrialsgov, Sep. 11, 2007,
`accessed from <http://c1inica1trials.gov/cl2/show/NCT00527904>
`on Sep. 6, 2012.
`
`(Continued)
`
`Primary Examiner 7 Gina Justice
`(74) Attorney, Agent, or Firm 7 Parker Highlander PLLC
`
`ABSTRACT
`(57)
`The present disclosure is directed to a method for delivering
`a pharmaceutical composition to a patient in need thereof,
`comprising: administering to said patient a pharmaceutical
`composition in tmit dose form comprising naproxen, or phar-
`maceutically acceptable salt thereof, and esomeprazole, or
`pharmaceutically acceptable salt thereof.
`
`7 Claims, 9 Drawing Sheets
`
`(54) METHOD FOR DELIVERING A
`PHARMACEUTICAL COMPOSITION TO
`PATIENT IN NEED THEREOF
`.
`.
`(71) ApphcamSIPOZEN INC“: Chapel H111, NC (US);
`HORIZON PHARMA USA, INC.,
`Deerfield, IL (US)
`
`(72)
`
`Inventors: Brian Ault, Wilmington, DE (US);
`Everardus Orlemans, Chapel Hill, NC
`(US); John R. Plachetka, Chapel H111,
`NC (Us); Mark Sosteka \Vihnjngtona
`DE (US)
`
`.
`.
`(73) ASSlgneeSI Pozen Inca Chapel H111, NC (US);
`Horizon Pharma USA, Inc., Deerfield,
`IL (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U-S-C- 154(1))10’ 0 dZYS-
`.
`.
`.
`.
`.
`This patent is subject to a terminal d1s-
`claimer.
`
`(21) App]. N0.: 14/980,639
`~
`,
`(22) Ffled'
`
`(65)
`
`Dec' 28’ 2015
`_
`_
`_
`Prior Publlcatlon Data
`
`US 2016/0106678 A1
`
`Apr. 21, 2016
`
`Related US. Application Data
`(63) Continuation of application No. 12/553,107, filed on
`Sep. 3, 2009, now Pat. No. 9,220,698.
`
`(60) Provisional application No. 61/095,584, filed on Sep.
`9, 2008.
`
`(51)
`
`Int. Cl.
`A61K 9/24
`A61K 31/192
`A61K 31/4439
`A61K 9/00
`(52) US. C1.
`CPC ............... A61K 9/209 (2013.01), A61K 9/0053
`(2013.01);A61K31/192 (2013.01);A61K
`31/4439 (2013.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(58) Field of Classification Search
`CPC ........................... A61K 9/209; A61K 31/4439
`See application file for complete search history.
`
`(56)
`
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`MYLAN PHARMS. INC. EXHIBIT 1001 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1001 PAGE 1
`
`

`

`US 9,393,208 B2
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`383%
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`
`0 167 958
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`
`0 320 550
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`
`0 426 479 B1
`0 550 083
`
`1 726 300
`1 726 301
`
`2 105 193
`2 163 747
`2 216 413
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`WO 85/03433
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`WO 91/16886
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`WO91/16896
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`WO 91/19712
`WO 93/11750
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`WO 94/27988
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`WO 96/05177
`WO 96/05199
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`WO 96/22780
`wo 97/11701
`wo 97/25064
`WO 98/13073
`WO 98/22117
`
`1/1986
`3/1986
`
`6/1989
`6/1989
`
`5/1991
`7/1993
`
`11/2006
`11/2006
`
`3/1983
`3/1986
`10/1989
`
`8/1985
`
`“/1991
`“/1991
`“/1991
`
`12/1991
`6/1993
`
`12/1994
`[/1995
`
`2/1996
`2/1996
`5/1996
`8/1996
`4/1997
`7/1997
`4/1998
`5/1998
`
`BE
`EP
`
`EP
`EP
`
`EP
`EP
`
`EP
`EP
`
`EP
`EP
`
`GB
`GB
`GB
`
`W0
`
`W0
`W0
`W0
`
`W0
`W0
`
`W0
`W0
`
`W0
`W0
`W0
`W0
`wo
`wo
`W0
`W0
`
`9/2001 Barberich et a1.
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`
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`MYLAN PHARMS. INC. EXHIBIT 1001 PAGE 2
`
`2 01/0025107 A1
`2 02/0012676 A1
`2 02/0042433 A1
`
`2 02/0045184 A1
`
`2 02/0086029 A1
`2 02/0090395 A1
`2 02/0111370 A1
`
`2 02/0160046 A1
`2 03/0008903 A1
`
`2 03/0113375 A1
`2 03/0129235 A1
`
`2 03/0232080 A1
`2 03/0232876 A1
`2 04/0022846 A1
`2 04/0048896 A1
`2 04/0121004 A1
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`
`
`MYLAN PHARMS. INC. EXHIBIT 1001 PAGE 2
`
`

`

`US 9,393,208 B2
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`W0
`W0 99/29320
`W0
`WO 99/66919
`W0
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`W0
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`W0
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`W0
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`W0
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`W0
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`W0
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`W0
`W0 01/24777
`W0
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`W0
`“/0 02/066002
`WO
`“/0 02/098352
`WO
`“/0 03/017980
`WO
`WO 2004/062552
`W0
`WO 2004/064815
`W0
`W0 W0 2005/074536
`W0
`WO 2005/074930
`W0
`WO 2006/044202
`W0
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`W0
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`W0
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