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Last Updated: September 21, 2021

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Claims for Patent: 9,522,191


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Summary for Patent: 9,522,191
Title:Modified release formulations containing drug--ion exchange resin complexes
Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.
Inventor(s): Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ)
Assignee: Tris Pharma, Inc. (Monmouth Junction, NJ)
Application Number:14/508,613
Patent Claims: 1. Williams & Watkins. 1995. cited by applicant .
Pelham et al. Once-a-Day Concerta Methylphenidate Verses Three-Times-Daily Methylphenidate in Laboratory and Natural Settings. Pediatrics. vol. 107(6):1-15. Jun. 1, 2001. cited by applicant .
Greenhill et al. Double-Blind, Placebo-Controlled Study of Modified-Release Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder. Pediatrics. vol. 109(3):1-7. Mar. 1, 2002. cited by applicant .
Swanson et al. Comparison of Once-Daily Extended-Release Methylphenidate Formulations in Children With Attention-Deficit/Hyperactivity Disorder in the Laboratory School (The Comacs Study). Pediatrics. vol. 113(3):206-216. Mar. 3, 2004. cited by applicant .
Product Literature, Concerta.RTM., (methylphenidate HCI) Extended-release Tablets, rev Nov. 2010. cited by applicant .
Product Literature, Daytrana.RTM. (methylphenidate transdermal system), revised Dec. 2009. cited by applicant .
Metadate CD.RTM., Product Label, 2013. cited by applicant .
Metadate CD.RTM. NDA Approval Letter from the Department of Health and Human Services, dated Feb. 2, 2001. cited by applicant .
Quillivant.RTM. XR, Highlights of Prescribing Information, Label Revised Dec. 2013. cited by applicant .
Quillivant.RTM. XR NDA Approval Letter from the Department of Health and Human Services, dated Sep. 27, 2012. cited by applicant .
Focalin.RTM. XR, Highlights of Prescribing Information, Label Revised Jan. 2012. cited by applicant .
Focalin.RTM. XR NDA Approval Letter from the Department of Health and Human Services, dated May 26, 2005. cited by applicant .
Methylin.RTM. ER NDA Approval Letter from the Department of Health and Human Services, dated May 9, 2000. cited by applicant .
Ritalin-SR.RTM., Product Label, Dec. 13, 2013. cited by applicant .
Ritalin-SR.RTM. NDA Approval Letter from the Department of Health and Human Services, dated May 21, 2004. cited by applicant .
Ritalin-LA.RTM., Product Label, Dec. 13, 2013. cited by applicant .
Ritalin-LA.RTM. NDA Approval Letter from the Department of Health and Human Services, dated Jun. 5, 2002. cited by applicant .
Kathala, U.S. Appl. No. 15/200,625, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,617, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,748, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,786, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 14/679,427, filed Apr. 6, 2015. cited by applicant .
Mehta, U.S. Appl. No. 14/679,438, filed Apr. 6, 2015. cited by applicant.

Primary Examiner: Tran; Susan
Assistant Examiner: Craigo; William
Attorney, Agent or Firm: Howson & Howson LLP Kodroff, Esq.; Cathy A. Berg, Esq.; Egon

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