Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`USS.C. 154(b) by 0 days.
`(Continued)
`This patent is subject to a terminal dis-
`Primary Examiner — Benjamin J Packard
`claimer.
`(74) Attorney, Agent, or Firm Alston & Bird LLP
`(21) Appl. No.: 18/067,287
`
`(22) Filed:—Dee. 16, 2022 67) ABSTRACT
`
`,
`The subject matter described herein is directed to stable
`Related U.S. Application Data
`I.-cysteine compositions for injection, comprising: [_-cyste-
`(63) Continuation of application No. 17/950,964, filed on
`ine or a pharmaceutically acceptable salt thereof and/or
`Sep. 22, 2022, whichis a continuation ofapplication
`hydrate thereof in an amount from about 10 mg/mL to about
`,
`,
`(Continued
`100 mg/mL; Aluminum in an amount from about 1.0 parts
`ontinued)
`per billion (ppb) to about 250 ppb; cystine im an amount
`from about 0.01 wt % to about 2 wt %relative to L-cysteine;
`pyruvic acid in an amount from about 0.01 wt % to about 2
`wl % relative to L-cysteine: a pharmaceutically acceptable
`carrier, comprising water; headspace O, that is less than
`1.0%; dissolved oxygen present in the carrier in an amount
`from about 0.01 parts per million (ppm) to about 1 ppm,
`wherein the composition is enclosed in a single-use con-
`tainer having a volume of from 10 mL to 100 mL. Also
`described are compositions for a total parenteral nutrition
`regimen and methods for their usc.
`
`(51)
`
`Int. Cl
`A61K 33/06
`ABL 33/16
`oe
`
`(2006.01)
`(2016.01)
`.
`,
`(Continued)
`
`(2) US. Cl
`CPC vrreeseseenes AGIK 33/06 (2013.01); A23E 33/16
`(2016.08), A23L 33/1 75 (2016.08); A61K
`9/0029 (2013.01), A6LK 31/095 (2013.01);
`AGLK 31/191] (2013.01); AGIK 31/198
`(2013.01), A6LK 31/401 (2013.01);
`(Continued)
`
`US011642370B1
`
`a2, United States Patent
`US 11,642,370 B1
`do) Patent No:
`Maloneyet al.
`(45) Date of Patent:
`*May 9, 2023
`
`
`(54) STABLE, HIGHLY PURE L-CYSTEINE
`COMPOSITIONS FOR INJECTLON AND
`
`(58) Field of Classification Search
`
`CPC viecccccecnessssesestensssescsrecseeraenee A61K 33/06
`
`METHODS OF USE
`
`See application file for complete search history.
`
`(71) Applicant: EXELA PHARMA SCIENCES, LLC,
`Lenoir, NC (US)
`
`(56)
`
`(72)
`
`Inventors: John Maloney, Salisbury, NC (US);
`‘
`A
`:
`PhaneshKemet:WerhovnNe(US)
`;
`,
`(73) Assignee: EXELA PHARMA SCIENCES, LLC,
`Lenoir, NC (US)
`
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`/1983. Nak
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`1385,
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`
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`
`30 Claims, 5 Drawing Sheets
`
`12.0
`10.0
`
`2.0
`0.0
`
`14.0 }
`
`Dissclved Oxygen Levels per Tray
`
`
`
`:
`ssaieesTray 1
`:
`}
`sagesTray 2
`:
`Sw
`:
`contenTray 3
`:
`Bs sag
`|
`segoeeTray 4
`SP,
`angieTray 17 |
`©
`&
`oN &
`sss Tray 18 |
`i
`
`santosTray 19 i
`=
`aecneesTray 20 §
`: & 8.0
`
`
`:
`7a
`“Tray 21 ;
`:Q
`
`sesfeosTray 22 ;
`6.0
`:
`
`cote Tray 23 j
`:
`
`40
`“Tray 24 }
`g
`
`Tray 37 :
`Tray 38 {
`Tray 39 :
`Tray 40 {
`:
`
` Post Filling -Pre HSR_—
`
`PostFilling - During
`Loading of Lyo
`
`
`Post HSR -Capping-
`Filled Vials
`
`
`Final Dissolved
`Oxygen Compounding
`
`Nexus Ex. 1001
`Page 1 of 46
`
`Nexus Ex. 1001
`Page 1 of 46
`
`

`

`US 11,642,370 B1
`Page 2
`
`Related U.S. Application Data
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`No. 16/665,702, filed on Oct. 28, 2019, nowPat. No.
`10,583,155, which is a continuation of application
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`2006.01)
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`
`
`Int. CL
`AGIK 31/191
`AGIK 9/00
`AGIK 31/405
`AGIK 31/095
`A23BL 33/175
`AGIK 31/198
`AGIK 31/4172
`AGIK 31/401
`AGIK 33/28
`AGIK 33/241
`AGIK 33/36
`AGIK 33/00
`AGIK 47/02
`AGLI 1/14
`(52) U.S. Cl
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`
`
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`Nexus Ex. 1001
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`US 11,642,370 B1
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