`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23 Page 1of 27 PagelD #: 225
`
`EXHIBIT 5
`EXHIBIT 5
`
`
`
`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 2 of 27 PageID #: 226
`Case 1:23-cv-00013-TSK Document1-5 La|
`WAa
`
`
`US011318191B2
`
`a2) United States Patent
`US 11,318,191 B2
`(0) Patent No.:
`May3, 2022
`(45) Date of Patent:
`Engelund etal.
`
`(54) GLP-1 COMPOSITIONS AND USES
`THEREOF
`
`(71) Applicant: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(72)
`
`Inventors: Dorthe Kot Engelund, Holte (DK);
`Soeren Snitker, Holte (DK); Andrew
`Mark Louw, Vaerloese (DK)
`
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 17/177,438
`
`(22)
`
`Filed:
`
`Feb. 17, 2021
`
`(65)
`
`(30)
`
`Prior Publication Data
`
`US 2021/0252111 Al
`
`Aug. 19, 2021
`
`Foreign Application Priority Data
`
`Feb. 18, 2020
`Apr. 24, 2020
`Jun. 17, 2020
`Jun. 18, 2020
`Jan. 4, 2021
`Jan. 11, 2021
`Feb. 2, 2021
`
`(EP) wee ceessseseeneceesenees 20157963
`(EP)....
`... 20171240
`(EP)....
`... 20180645
`(EP)....
`... 20180832
`(EP)....
`... 21150056
`(EP)....
`... 21151004
`(EP) wee eeceeeeeeeeneeeeenee 21154657
`
`
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2017.01)
`(2006.01)
`
`Int. Cl.
`AGIK 38/26
`AGIK 9/00
`AGIK 47/02
`AGIK 47/10
`AGIK 47/22
`(52) U.S. Cl.
`CPC wee AGIK 38/26 (2013.01); AGLK 9/0019
`(2013.01); A6LK 47/02 (2013.01); A6LK 47/10
`(2013.01); A61K 47/22 (2013.01)
`(58) Field of Classification Search
`CPC vicecccscrssssecrsscnseecersetesenscnssenseeseonees A61K 38/26
`
`See application file for complete search history.
`
`(56)
`
`References Cited
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`OTHER PUBLICATIONS
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`
`(Continued)
`
`Primary Examiner — Gyan Chandra
`(74) Attorney, Agent, or Firm — Rosemarie R.
`Wilk-Orescan
`
`(57)
`
`ABSTRACT
`
`The present invention relates to pharmaceutical composi-
`tions of the GLP-1 peptide semaglutide comprising no more
`than 0.1% (w/w) phenol and above 6.4 mg/ml sodium
`chloride, their preparation, kits comprising such composi-
`tions as well as uses thereof.
`
`26 Claims, 1 Drawing Sheet
`
`
`
`Case 1:23-cv-00013-TSK Document 1-5 Filed 01/27/23 Page 3 of 27 PageID #: 227
`Page 3 of 27 PagelD #: 227
`Case 1:23-cv-00013-TSK Document1-5 Filed 01/27/23
`
`US 11,318,191 B2
`
`Page 2
`
`
`
`PPPPrSPPEEEEEPEPEEPPSESEPEEPSEEEEELSPEEPSPEESPPEESEPEEEPSPSESPESEPPSPrereerPPS
`
`(56)
`
`5,318,540
`5,320,609
`5,331,954
`5,370,629
`5,378,233
`5,380,297
`5,383,166
`5,383,865
`5,440,976
`5,445,606
`5,447,150
`5,455,331
`5,461,031
`5,478,316
`5,478,324
`5,480,387
`5,492,534
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`5,512,549
`5,514,097
`5,545,147
`5,545,618
`5,546,932
`5,549,574
`5,549,575
`5,571,719
`5,574,008
`5,584,815
`5,591,136
`5,599,314
`5,611,783
`5,614,492
`5,626,566
`5,645,052
`5,652,216
`5,674,204
`5,679,111
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`5,685,864
`5,686,411
`5,688,251
`5,693,027
`5,693,520
`5,693,608
`5,705,483
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`5,716,990
`5,725,508
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`5,743,889
`5,750,140
`5,755,692
`5,823,998
`5,827,232
`5,843,036
`5,849,700
`5,882,718
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`5,938,642
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`5,972,873
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