I IIIII
`
`1111111111111111111111111111111111111111111111111111111111111
`US008945621B2
`
`c12) United States Patent
`Ault et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,945,621 B2
`Feb.3,2015
`
`(54) METHOD FOR TREATING A PATIENT AT
`RISK FOR DEVELOPING AN
`NSAID-ASSOCIATED ULCER
`
`(75)
`
`Inventors: Brian Ault, Wilmington, DE (US);
`Clara Hwang, Wilmington, DE (US);
`Everardus Orlemans, Chapel Hill, NC
`(US); John R Plachetka, Chapel Hill,
`NC (US); Mark Sostek, Wilmington,
`DE (US)
`
`(73) Assignees: Pozen Inc., Chapel Hill, NC (US);
`Horizon Pharma USA, Inc., Deerfield,
`IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 480 days.
`
`(21) Appl. No.: 12/822,612
`
`(22) Filed:
`
`Jun.24,2010
`
`(65)
`
`Prior Publication Data
`
`US 2010/0330179 Al
`
`Dec. 30, 2010
`
`Related U.S. Application Data
`
`Provisional application No. 61/220,420, filed on Jun.
`25, 2009, provisional application No. 61/225,970,
`filed on Jul. 16, 2009, provisional application No.
`61/310,525, filed on Mar. 4, 2010.
`
`AU
`CA
`
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`4,948,581 A
`4,965,065 A
`5,026,560 A
`5,035,899 A
`5,037,815 A
`5,043,358 A
`5,051,262 A
`5,093,132 A
`5,204,118 A
`5,260,333 A
`5,364,616 A
`5,373,022 A
`5,409,709 A
`5,417,980 A
`5,466,436 A
`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
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`FOREIGN PATENT DOCUMENTS
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`2139653
`(Continued)
`
`OTHER PUBLICATIONS
`
`(60)
`
`(51)
`
`(52)
`
`(58)
`
`(56)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K9124
`A61K 311192
`A61K 3114439
`A61K 45106
`U.S. Cl.
`CPC ............... A61K 311192 (2013.01); A61K 91209
`(2013.01); A61K 3114439 (2013.01); A61K
`45106 (2013.01)
`USPC .......................................................... 424/472
`Field of Classification Search
`USPC .......................................................... 424/472
`See application file for complete search history.
`
`References Cited
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`(Continued)
`
`Primary Examiner- Adam C Milligan
`(74) Attorney, Agent, or Firm- Parker Highlander PLLC
`
`ABSTRACT
`(57)
`The present disclosure is directed to a method for treating a
`disease or disorder in a patient at risk of developing an
`NSAID-associated ulcer by administering to said patient in
`need thereof a pharmaceutical composition in unit dose form
`comprising naproxen, or pharmaceutically acceptable salt
`thereof, and esomeprazole, or pharmaceutically acceptable
`salt thereof to said at risk patient and thereby decreasing the
`patient's risk of developing an ulcer.
`
`16 Claims, No Drawings
`
`

`
`US 8,945,621 B2
`Page 2
`
`(56)
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`
`US 8,945,621 B2
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`US 8,945,621 B2
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