Details for Patent: 9,549,989

Title:	Modified release formulations containing drug-ion exchange resin complexes
Abstract:	A particulate, barrier coated drug-anion exchange resin complex comprising a core composed of an acidic drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The barrier coating contains a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.
Inventor(s):	Mehta; Ketan (Princeton, NJ), Tu; Yu-Hsing (West Windsor, NJ)
Assignee:	TRIS PHARMA, INC (Monmouth Junctoin, NJ)
Filing Date:	Feb 18, 2016
Application Number:	15/047,388
Claims:	1. 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 . Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Dec. 11, 2014 and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 8,062,667; 8,287,903; 8,465,765; 8,563,033; and 8,778,390 are Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant . Complaint by Tris Pharma, Inc. against Par Pharmaceutical, Inc. et al., C.A. No. 15-0068-GMS, dated Jan. 21, 2015. cited by applicant . 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, CA. 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. No. 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 . Office Action issued in Japanese Patent Application No. 2009-500494 and English translation of Notice of Reasons for Rejection, issued Oct. 8, 2013. cited by applicant . 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 . 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 . Notice of Allowance with Interview Summary issued on related U.S. Appl. No. 14/735,526, dated Oct. 13, 2015. cited by applicant . Response to Office Action dated Aug. 27, 2015, issued on related U.S. Appl. No. 14/735,526, dated Sep. 21, 2015. cited by applicant . Non-final Office Action issued on related U.S. Appl. No. 14/735,526, dated Aug. 27, 2015. cited by applicant . Tris Pharma Inc. vs. Actavis Laboratories., et al. Defendant Actavis Laboratories FL, Inc.'s Amended Initial Invalidity Contentions, C.A. No. 14-1309-GMS (consolidated), pp. 1-198, Jan. 22, 2016. cited by applicant . Tris Pharma Inc. vs. Actavis Laboratories., et al. Defendant Actavis Laboratories FL, Inc.'s Final Initial Invalidity Contentions, C.A. No. 14-1309-GMS (consolidated), pp. 1-203, Feb. 8, 2016. cited by applicant . European Search Report dated Jan. 20, 2012 and issued in European Patent Application No. 11192711.7, pp. 1-4. cited by applicant . Intention to Grant dated May 23, 2012 issued in European Patent Application No. 11192711.7, pp. 1-78. cited by applicant . U.S. Appl. No. 15/200,625, filed Jul. 1, 2016, Kathala. cited by applicant . U.S. Appl. No. 15/200,617, filed Jul. 1, 2016, Mehta. cited by applicant . U.S. Appl. No. 15/200,748, filed Jul. 1, 2016, Mehta. cited by applicant . U.S. Appl. No. 15/200,786, filed Jul. 1, 2016, Mehta. cited by applicant . U.S. Appl. No. 14/679,427, filed Apr. 6, 2015, Mehta. cited by applicant . U.S. Appl. No. 14/679,438, filed Apr. 6, 2015, Mehta. cited by applicant.

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