Case 1:14-cv-01453-LPS Document 96-1 Filed 04/01/16 Page 1 of 16 PageID #: 2065
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US009259428B2
`
`c12) United States Patent
`Lulla et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,259,428 B2
`*Feb.16,2016
`
`(54) COMBINATION OF AZELASTINE AND
`FLUTICASONE FOR NASAL
`ADMINISTRATION
`
`(71) Applicant: Cipla Limited, Mumbai (IN)
`
`(72)
`
`Inventors: Amar Lulla, Mumbai (IN); Geena
`Malhotra, Mumbai (IN)
`
`(73) Assignee: Cipla Limited, Mumbai (IN)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 14/661,720
`
`(22) Filed:
`
`Mar. 18, 2015
`
`(65)
`
`Prior Publication Data
`
`US 2015/0190405 Al
`
`Jul. 9, 2015
`
`Related U.S. Application Data
`
`(60) Continuation of application No. 14/539,646, filed on
`Nov. 12,2014, which is a continuation of application
`No. 13/644,127, filed on Oct. 3, 2012, now Pat. No.
`8,937,057, which is a continuation of application No.
`12/508,388, filed on Jul. 23, 2009, now Pat. No.
`8,318,709, which is a division of application No.
`10/518,016, filed as application No. PCT/GB03/02557
`on Jun. 13, 2003, now Pat. No. 8,168,620.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K 31156
`A61K9/00
`A61K 31155
`A61K 311573
`A61K 31158
`A61K 47110
`A61K 47118
`A61K 47126
`A61K 47138
`(52) U.S. Cl.
`CPC ............... A61K 31156 (2013.01); A61K 910043
`(2013.01); A61K 31155 (2013.01); A61K
`311573 (2013.01); A61K 31158 (2013.01);
`A61K 47110 (2013.01); A61K 471183
`(2013.01); A61K 471186 (2013.01); A61K
`47126 (2013.01); A61K 47138 (2013.01)
`(58) Field of Classification Search
`None
`See application file for complete search history.
`
`(56)
`
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`(Continued)
`
`Primary Examiner- Robert A Wax
`Assistant Examiner- Thor Nielsen
`(74) Attorney, Agent, or Firm- Conley Rose, P.C.; Rodney
`B. Carroll
`
`(57)
`
`ABSTRACT
`
`A pharmaceutical product or formulation, which comprises
`azelastine or a pharmaceutically acceptable salt, solvate or
`physiologically functional derivative thereof, and a steroid, or
`a pharmaceutical acceptable salt, solvate or physiologically
`functional derivative thereof, preferably the product or for(cid:173)
`mulation being in a form suitable for nasal or ocular admin(cid:173)
`istration.
`
`30 Claims, No Drawings
`
`

`
`Case 1:14-cv-01453-LPS Document 96-1 Filed 04/01/16 Page 2 of 16 PageID #: 2066
`
`US 9,259,428 B2
`Page 2
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`
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`

`
`Case 1:14-cv-01453-LPS Document 96-1 Filed 04/01/16 Page 3 of 16 PageID #: 2067
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`US 9,259,428 B2
`Page 3
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