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`Case 1:14—cv—O1453—LPS Document 1-2 Filed 12/02/14 Page 1 of 16 Page|D #: 31 1
`
`EXHIBIT B
`
`

`
`Case 1:14-cv-01453-LPS Document 1-2 Filed 12/02/14 Page 2 of 16 PageID #: 32
`“I||1|l1|II||1Ifl|1F|I1fl|||r’11H|1||1|l|||fl|1l|1’fl1Ifi||I’||1|||F
`
`US008l68620B2
`
`(12) Ulllted States Patent
`Lulla et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,168,620 B2
`May 1, 2012
`
`(54) COMBINATION OF AZELASTINE AND
`
`(75)
`
`,
`Inventors: Amar Lulla, Mumbai (IN); Geena
`Malhotra, Mumbai (IN)
`
`(
`
`(73) Assignee: CIPLA Limited, Mumbai (1N)
`.
`*
`.
`.
`.
`.
`) Not1ce:
`Subject to any d1scla1mer, the term of this
`patent is extended or adjusted under 35
`USC, 1540.)) by 987 days,
`
`(21) APP1~N0~I
`
`10/513,016
`
`(22) PCT Filed:
`
`Jun. 13, 2003
`
`PCT/G303/02557
`
`.
`(86) PCT No"
`w1<c><1>s
`J“1-@2005
`(2)=(4)Da‘e3
`(87) PCT Pub. No.: WO03/105856
`PCT Pub. Date: Dec-24,2003
`
`Prior Publication Data
`US 2006/0025391 A1
`Feb. 2, 2006
`
`(65)
`
`(30)
`
`4,251,984 A
`2%2%’i§§:§
`4:285:937 A
`4,310,466 A
`4,335,121 A
`4,377,575 A
`:
`4,710,495 A
`4,351,755 A
`4,992,474 A
`4,994,439 A
`4,996,335 A
`5,063,222 A
`5,081,113 A
`5,164,194 A
`5,202,316 A
`5,232,919 A
`5,271,946 A
`5,362,721 A
`§’232’é§22‘
`5:658:549 A
`5,658,919 A
`5,707,984 A
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`5,889,015 A
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`
`FOREIGN PATENT DOCUMENTS
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`
`Jun. 14, 2002
`
`(GB) ................................. .. 0213739.6
`
`(Continued)
`
`(51)
`
`Int. Cl.
`(200601)
`A01N 45/00
`(2006.01)
`A6IK3I/56
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`A 61K 31/55
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`A6IK3I/57
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`A61K31/58
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`A61K 9/00
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`A611’ 3 7/08
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`A6IP 2 7/14
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`A61P 11/06
`(52) U.s. Cl.
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`(58) Field ofClassification Search ................. .. 514/171
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`(beclomethasone) and an antihistaminic (azelastine); vol. 121, No. 4,
`2000, pp. 273-279.
`
`(Continued)
`
`Primary Examiner — Johann Richter
`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 pharmaceutically acceptable salt, solvate or physiologically
`functional derivative thereof, preferably the product or for-
`mulation being in a form suitable for nasal or ocular admin-
`istration.
`
`48 Claims, No Drawings
`
`

`
`Case 1:14-cv-01453-LPS Document 1-2 Filed 12/02/14 Page 3 of 16 PageID #: 33
`Case 1:14—cv—O1453—LPS Document 1-2 Filed 12/02/14 Page 3 of 16 Page|D #: 33
`
`US 8,168,620 B2
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`GB
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`
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`W0
`W8
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
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`W0
`W0
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`
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`WO
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`
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`
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`
`

`
`Case 1:14-cv-01453-LPS Document 1-2 Filed 12/02/14 Page 4 of 16 PageID #: 34
`Case 1:14-cv-01453-LPS Document 1-2 Filed 12/02/14 Page 4 of 16 Page|D #: 34
`
`US 8,168,620 B2
`Page 3
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`

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