Exhibit 1013
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1013
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01800
`
`

`
`(12) United States Patent
`Watts et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 8,889,176 B2
`*Nov. 18, 2014
`
`US008889l76B2
`
`(54) METHOD OF MANAGING OR TREATING
`PAIN
`
`(75)
`
`I11ve11tors: Peter James Watts, Nottingham (GB);
`Jonathan David Castile, Nottingham
`(GB); William Columbus Lafferty,
`Leicester (GB); Alan Smith, Nottingham
`(GB)
`
`(73) Assignee: Depomed, Inc.; Newark, CA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 8 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl.No.: 13/541,314
`
`(22) Filed:
`
`Jul. 3, 2012
`
`(65)
`
`Prior Publication Data
`
`US 2012/0277267 A1
`
`NOV. 1, 2012
`
`Related U.S. Application Data
`
`(60) Continuation of application No. 12/047,388, filed on
`Mar. 13, 2008, now Pat. No. 8,216,604, which is a
`division of application No. 10/753,628, filed on Jan. 8,
`2004, now abandoned.
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 10. 2003
`
`(GB) ................................. .. 0300531.1
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61F 13/00
`A61K 31/445
`A01N43/40
`A01N 43/16
`A61K 31/35
`(52) U.S. Cl.
`USPC .......................... .. 424/434; 514/317; 514/453
`(58) Field of Classification Search
`USPC ........................................................ .. 424/434
`See application file for complete search history.
`
`(56)
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`Primary Examiner — Layla Soroush
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`LLP
`
`(57)
`
`ABSTRACT
`
`A composition for the intranasal delivery of fentanyl or a
`pharmaceutically acceptable salt
`thereof to an animal
`includes an aqueous solution of fentanyl or a pharmaceuti-
`cally acceptable salt thereof a11d a pharmaceutically accept-
`able additive selected from (i) a pectin and (ii) a poloxamer
`and chitosan or a salt or derivative thereof; provided that when
`the composition comprises a pectin it is substantially free of
`divalent metal ions; and Which. in comparison to a simple
`aqueous solution of fentanyl administered intranasally at the
`same dose, provides a peak plasma concentration of fentanyl
`(CWM) that is from 10 to 80% ofthat achieved using a simple
`aqueous solution of fentanyl administered intranasally at an
`identical fentanyl dose. A method for treating or managing
`pain by intranasally administering the composition is also
`disclosed.
`
`40 Claims, 2 Drawing Sheets
`
`

`
`US 8,889,176 B2
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