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Details for Patent: 9,198,864

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Details for Patent: 9,198,864

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 .
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. Nos. 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, 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 .
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 .
Biederman, "New Generation Long-Acting Stimulants for the Treatment of Attention-Deficit/Hyperactivity Disorder", Medscape Psychiatry, vol. 8(2), Nov. 2003. cited by applicant .
Cascade et al., "Short-Acting Versus Long-Acting Medications for the Treatment of ADHD", Psychiatry, vol. 5(8):24-27, Aug. 2008. cited by applicant .
Chavez et al., "An Update on Central Nervous System Stimulant Formulations in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder", The Annals of Pharmacotherapy, vol. 43(6):1084-1095, Jun. 2009. cited by applicant .
CONCERTA.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-121, Center for Drug Evaluation and Research, Jun. 2000. cited by applicant .
CONCERTA.RTM., Medical Reviews, App. No. 21-121, Center for Drug Evaluation and Research, Jul. 1999 (completed Mar. 2000). cited by applicant .
Connors et al., Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists (2.sup.nd Ed.), John Wiley & Sons, pp. 587-589., Jan. 1986. cited by applicant .
Daughton et al., "Review of ADHD Pharmacotherapies: Advantages, Disadvantages, and Clinical Pearls", J. Am. Acad. Child and Adolescent Psychiatry, vol. 48(3):240-248, Mar. 2009. cited by applicant .
DAYTRANA.RTM., Clinical Pharamacology and Biopharmaceutics Reviews, App. No. 21-514, Center for Drug Evaluation and Research, Jun. 2005. cited by applicant .
DAYTRANA.RTM., Medical Reviews, App. No. 21-514, Center for Drug Evaluation and Research, Feb. 2006. cited by applicant .
Ermer et al., "Pharmacokinetic Variability of Long-Acting Stimulants in the Treatment of Children and Adults with Attention-Deficit/Hyperactivity Disorder", CNS Drugs, vol. 24(12):1009-1025, Dec. 2010. cited by applicant .
Flynn, "Buffers--pH Control within Pharmaceutical Systems", J. Parenteral Drug Association, vol. 34(2):139-162, Mar. 1980. cited by applicant .
Focalin.RTM. XR, Clinical Pharamacology and Biopharmaceutics Reviews, App. No. 21-802, Center for Drug Evaluation and Research, Jul. 2004. cited by applicant .
Focalin.RTM. XR, Medical Review, App. No. 21-802, Center for Drug Evaluation and Research, Jul. 2004. cited by applicant .
Ghuman et al., "Psychopharmacological and Other Treatments in Preschool Children with Attention Deficit/Hyperactivity Disorder: Current Evidence and Practice", J. Child and Adolescent Psychopharmacology, vol. 18(5):413-447, Oct. 2008. cited by applicant .
Gonzales et al., "Methylphenidate Bioavailability from Two Extended-Release Formulations", Int'l J. Clinical Pharmacology and Thereapeutics, vol. 40(4):175-184, Apr. 2002. cited by applicant .
Kulshreshtha et al. (Eds.), Pharmaceutical Suspensions: From Formulation Development to Manufacturing, Springer Science & Business Media, Jan. 2009. cited by applicant .
Metadate CD.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-259, Center for Drug Evaluation and Research, Mar. 2001. cited by applicant .
Metadate CD.RTM., Medical Reviews, App. No. 21-259, Center for Drug Evaluation and Research, Mar. 2000. cited by applicant .
Methylin.RTM. ER, Approval Letter and Reviews, App. No. 75-629, Center for Drug Evaluation and Research, May 2000. cited by applicant .
Methylin.RTM. Oral Solution, Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-419, Center for Drug Evaluation and Research, Jul. 2001. cited by applicant .
Methylin.RTM. Oral Solution, Chemistry Reviews, App. No. 21-419, Center for Drug Evaluation Research, May 2002. cited by applicant .
Methylin.RTM. Oral Solution, Medical Reviews, App. No. 21-419, Center for Drug Evaluation and Research, May 2002. cited by applicant .
Patrick et al., "Evolution of Stimulants to Treat ADHD: Transdermal Methylphenidate", Human Psychopharmacology, vol. 24(1):1-17, Jan. 2009. cited by applicant .
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 .
The Physicians' Desk Reference (60.sup.th ed.), "Metadate CD.RTM.", pp. 3439-3443, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Tussionex.RTM.", pp. 3443-3444, Jan. 2010. cited by applicant .
The Physicians' Desk Reference for Non-Prescription Drugs, Dietary Supplements, and Herbs (29.sup.th Ed.), "Delsym.RTM.", pp. 602-603, Jan. 2008. cited by applicant .
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 .
Prince, "Pharmacotherapy of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Update on New Stimulant Preparations, Atomoxetine, and Novel Treatments", Child and Adolescent Psychiatric Clin N. Am., vol. 15:13-50, Jan. 2006. cited by applicant .
Remington, "The Science and Practice of Pharmacy (20.sup.th Ed)", pp. 986-994, Jan. 2000. cited by applicant .
Ritalin LA.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-284, Center for Drug Evaluation and Research, Dec. 2001. cited by applicant .
Ritalin LA.RTM., Medical Review(s), App. No. 21-284, Center for Drug Evaluation and Research, Nov. 2000. 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):206-16, Mar. 2004. cited by applicant .
The Pharmacopeia of the United States (25.sup.th revision), "Pharmaceutical Dosage Forms", pp. 2213-2225, Nov. 2001. cited by applicant .
Wigal et al., "Selection of the Optimal Dose Ratio for a Controlled-Delivery Formulation of Methylphenidate", J. Appl. Research., vol. 3:46-63, Oct. 2003. cited by applicant .
Codeprex .RTM., Product Label, marketed by UCB, Inc., Jun. 21, 2004. cited by applicant .
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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