`US009326966B2
`
`c12) United States Patent
`Scharschmidt et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 9,326,966 B2
`*May 3, 2016
`
`(54) METHODS OF THERAPEUTIC
`MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`(71) Applicant: Horizon Therapeutics, Inc., Deerfield,
`IL (US)
`
`(72)
`
`Inventors: Bruce Scharschmidt, San Francisco,
`CA (US); Masoud Mokhtarani, Walnut
`Creek, CA (US)
`
`A61K31/235
`A61K9/00
`(52) U.S. Cl.
`CPC ............. A61K 311235 (2013.01); A61K 910053
`(2013.01)
`
`(2006.01)
`(2006.01)
`
`(58) Field of Classification Search
`CPC ............... A61K 31/216; GOIN 31/221; YlOT
`436/175383
`See application file for complete search history.
`
`(73) Assignee: Horizon Therapeutics, Inc., Lake
`Forest, IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`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.: 14/958,259
`
`(22) Filed:
`
`Dec. 3, 2015
`
`(65)
`
`Prior Publication Data
`
`US 2016/0081969 Al
`
`Mar. 24, 2016
`
`Related U.S. Application Data
`
`(63)
`
`(60)
`
`(51)
`
`Continuation of application No. 14/816,674, filed on
`Aug. 3, 2015, now Pat. No. 9,254,278, which is a
`continuation of application No. 13/775,000, filed on
`Feb. 22, 2013, now Pat. No. 9,095,559, which is a
`continuation of application No. 13/417,137, filed on
`Mar. 9, 2012, now Pat. No. 8,404,215.
`
`Provisional application No. 61/542,100, filed on Sep.
`30, 2011, provisional application No. 61/564,668,
`filed on Nov. 29, 2011.
`
`Int. Cl.
`A61K 49100
`A61P 13100
`
`(2006.01)
`(2006.01)
`
`(56)
`
`References Cited
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`
`Primary Examiner - Savitha Rao
`
`ABSTRACT
`(57)
`The present disclosure provides methods for evaluating daily
`ammonia exposure based on a single fasting ammonia blood
`level measurement, as well as methods that utilize this tech(cid:173)
`nique to adjust the dosage of a nitrogen scavenging drug,
`determine whether to administer a nitrogen scavenging drug,
`and treat nitrogen retention disorders.
`
`15 Claims, 3 Drawing Sheets
`
`1 of 22
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`US 9,326,966 B2
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