(12) United States Patent
`Brittain et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,791,270 B2
`Jul. 29, 2014
`
`US008791270B2
`
`(54) BENDAMUSTINE PHARMACEUTICAL
`COMPOSITIONS
`
`(71) Applicant: Cephalon, Inc., Frazer, PA (US)
`
`(72) Inventors: Jason Edward Brittain, El Cajon, CA
`(US); Joe Craig Franklin, Tulsa, OK
`(Us)
`
`(73) Assignee: Cephalon, Inc., Frazer, PA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) App1.No.: 13/969,724
`
`(22) Filed:
`
`Aug. 19, 2013
`
`(65)
`
`Prior Publication Data
`
`US 2013/0338205 A1
`
`Dec. 19, 2013
`
`Related US. Application Data
`
`(63) Continuation of application No. 13/719,409, ?led on
`Dec. 19, 2012, Which is a continuation of application
`No. 13/654,898, ?led on Oct. 18, 2012, noW Pat. No.
`8,461,350, Which is a continuation of application No.
`11/330,868, ?led on Jan. 12, 2006, noW Pat. No.
`8,436,190.
`(60) Provisional application No. 60/644,354, ?led on Jan.
`14, 2005.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(51) Int. Cl.
`C07D 235/04
`A61K 47/10
`A61K 31/4184
`A61K 9/19
`A61K 9/00
`(52) US. Cl.
`CPC .A61K 9/19 (2013.01); A61K 47/10 (2013.01);
`A61K31/4184 (2013.01); A61K 9/0019
`(2013.01)
`USPC ........................................ .. 548/304.7; 34/284
`(58) Field of Classi?cation Search
`USPC .......................................................... .. 34/284
`See application ?le for complete search history.
`
`(56)
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`DE
`DE
`DE
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`DE
`DE
`DE
`DE
`DE
`EP
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`
`Primary Examiner * Ali Soroush
`(74) Attorney, Agent, or Firm * Baker & Hostetler LLP
`
`ABSTRACT
`(57)
`The present invention provides pharmaceutical formulations
`of lyophilized bendamustine suitable for pharmaceutical use.
`The present invention further provides methods of producing
`lyophilized bendamustine. The pharmaceutical formulations
`can be used for any disease that is sensitive to treatment With
`bendamustine, such as neoplastic diseases.
`
`23 Claims, 6 Drawing Sheets
`
`AGILA ET AL - EXHIBIT 1001
`
`

`
`US 8,791,270 B2
`US 8,791,270 B2
`Page 2
`Page 2
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`US 8,791,270 B2
`US 8,791,270 B2
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`
`

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