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Last Updated: March 28, 2024

Details for Patent: 9,198,864


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Title:Modified release formulations containing drug-ion exchange resin complexes
Abstract: A tablet comprising a coated drug-ion exchange resin complex composed of methylphenidate complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated methylphenidate-ion exchange resin complex is provided. The coated methylphenidate-ion exchange resin complex is in admixture with a polymer to form a matrix. Also provided is a tablet comprising a coated drug-ion exchange resin complex composed of dexmethylphenidate complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated dexmethylphenidate-ion exchange resin complex is provided. The coated dexmethylphenidate-ion exchange resin complex is in admixture with a polymer to form a matrix.
Inventor(s): Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ)
Assignee: TRIS PHARMA, INC (Monmouth Junction, NJ)
Filing Date:Jun 10, 2015
Application Number:14/735,526
Claims:1. cited by applicant .
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Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to Complaint and Counterclaims, C.A. No. 15-0068-GMS, dated Feb. 12, 2015. cited by applicant .
Answer to Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Counterclaims, C.A. No. 15-0068-GMS, dated Feb. 26, 2015. cited by applicant .
Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Apr. 2, 2015, and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 8,956,649 is Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant .
Notice of Paragraph IV Certification from Actavis, dated Sep. 3, 2014 and "Detailed Factual and Legal Bases for Actavis's Paragraph IV Certification that U.S. Pat. Nos. 8,062,667; 8,287,903; 8,465,765; 8,563,033; and 8,778,390 are Invalid, Unenforceable, and/or Not Infringed." cited by applicant .
Complaint by Tris Pharma, Inc. against Actavis Laboratories FL, Inc. et al., C.A. No. 14-1309-GMS, dated Oct. 15, 2014. cited by applicant .
Defendant Actavis Laboratories FL, Inc.'s Answer, Defenses, and Counterclaims, C.A. No. 14-1309-GMS, dated Dec. 5, 2015. cited by applicant .
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Defendant Actavis Laboratories FL, Inc.'s Answer, Affirmative Defenses, and Counterclaims, C.A. No. 15-393-GMS, dated Jun. 12, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Initial Invalidity Contentions, C.A. No. 14-1309-GMS, dated Jun. 10, 2015. cited by applicant .
Defendant Actavis Laboratories FL, Inc.'s Initial Invalidity Contentions, C.A. No. 14-1309-GMS, dated May 27, 2015. cited by applicant .
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DAYTRANA.RTM., Medical Reviews, App. No. 21-514, Center for Drug Evaluation and Research, Feb. 2006. cited by applicant .
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The Physicians' Desk Reference (60.sup.th ed.), "Ritalin.RTM. LA", pp. 3104-3106, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Concerta.RTM.", pp. 2598-2604, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Daytrana.RTM.", pp. 3283-3289, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Focalino" XR, pp. 2472-2477, Jan. 2010. cited by applicant .
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Greenhill et al., "Practice Parameter for the Use of Stimulant Medications in the Treatment of Children, Adolescents, and Adults", J. Am. Acad. Child and Adolescent Psychiatry, vol. 41(2):265-495 (supplement), Feb. 2002. cited by applicant .
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Ritalin LA.RTM., Medical Review(s), App. No. 21-284, Center for Drug Evaluation and Research, Nov. 2000. cited by applicant .
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Methylin.RTM. Oral Solution, Product Label, marketed by Mallinckrodt Inc., May 2006. cited by applicant .
Methylin.RTM. ER, Product Label, marketed by Mallinckrodt Inc., Oct. 2013. cited by applicant .
Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Jun. 17, 2015, and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 9,040,083 is Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant .
Answer to Actavis Laboratories FL, Inc.'s Counterclaims, C.A. No. 14-1309-GMS, dated Dec. 29, 2014. cited by applicant .
First Amended Complaint, C.A. No. 14-1309-GMS, dated May 22, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to First Amended Complaint and Counterclaims, dated Jun. 12, 2015. cited by applicant .
Complaint by Tris Pharma, Inc. against Actavis Laboratories FL, Inc., et al., C.A. No. 15-393-GMS, dated May 15, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to Second Amended Complaint and Counterclaims, C.A. No. 14-1309-GMS, dated Aug. 24, 2015. cited by applicant .
Notice of Paragraph IV Certification from Actavis, dated Sep. 9, 2015, and "Actavis's Detailed Factual and Legal Bases for Its Paragraph IV Certification that U.S. Pat. No. 9,040,083 is Invalid, Unenforceable and/or Not Infringed." cited by applicant.

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

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