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Oral Solutions Comprising Lisdexamfetamine Salts - EP3845215

The patent EP3845215 was granted to Adalvo on Jul 27, 2022. The application was originally filed on Dec 30, 2019 under application number EP19386059A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3845215

ADALVO
Application Number
EP19386059A
Filing Date
Dec 30, 2019
Status
Granted And Under Opposition
Jun 24, 2022
Grant Date
Jul 27, 2022
External Links
Slate, Register, Google Patents

Patent Summary

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APPLEYARD LEESApr 26, 2023ADMISSIBLE

Patent Citations (5) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS7105486
DESCRIPTIONWO2006121552
OPPOSITIONWO2006121552
SEARCHUS7105486
SEARCHWO2006121552

Non-Patent Literature (NPL) Citations (21) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- DAVID W. GOODMAN, "Lisdexamfetamine dimesylate. The first prodrug stimulant", Psychiatry (Edgmont), (20070800), vol. 4, no. 8, pages 39 - 45-
DESCRIPTION- SHENGHUA G., "Identification, characterization and quantification of process-related and degradation impurities in lisdexamfetamine dimesylate: identification of two new compounds", molecules, (20181200), vol. 23, no. 12, page 3125-
OPPOSITION- Anonymous, "APPLICATION OF WATER ACTIVITY DETERMINATION TO NONSTERILE PHARMACEUTICAL PRODUCTS", The United States Pharmacopeial Convention, (20120501), The United States Pharmacopeial Convention, XP093152960-
OPPOSITION- Anonymous, "FDA approval for lisdexamfetamine dimesylate", Chemistry Review; NDA 21-977 NRP 104 (lisdexamfetamine dimesylate), (20060901), Chemistry Review; NDA 21-977 NRP 104 (lisdexamfetamine dimesylate) , URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021977s000_ChemR.pdf, XP093152957-
OPPOSITION- Anonymous, "Vyvanse TM (lisdexamfetamine dimesylate) C-II Rx Only AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS", FDA, (20070101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf, XP093152964-
OPPOSITION- Anonymous, "Xylitol", Anonymous, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 786 - 789, ISBN 978-0-85369-792-3, XP055694191-
OPPOSITION- David W Goodman, "Lisdexamfetamine dimesylate: the first prodrug stimulant", Psychiatry, United States, United States, (20070801), pages 39 - 45, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880945/pdf/PE_4_8_39.pdf, XP093152967-
OPPOSITION- John F. Marriott, "6 Solutions", John F. Marriott, John Marriott, Keith Wilson, Christopher A. Langley, Dawn Belcher, PHARMACEUTICAL COMPOUNDING AND DISPENSING 2nd Edition, Pharmaceutical Press, (20100518), pages 101 - 114, ISBN 978-0-85369-912-5, XP009555221-
OPPOSITION- José Luis Vila Jato, "3.6. Hidrosolubilizacióii de medicamentos", José Luis Vila Jato, José Luis Vila Jato, Technología fermacéutica: Aspectos fundamentales de los sistemas farmacéuticos y operaciones básicas, Editorial Sintesis, (20010501), pages 195 - 205, ISBN 84-7738-539-4, XP009554601-
OPPOSITION- José Luis Vila Jato, "Chapter 5: Estabilidad", José Luis Vila Jato, José Luis Vila Jato, Technología fermacéutica: Aspectos fundamentales de los sistemas farmacéuticos y operaciones básicas, Editorial Sintesis, (20010501), vol. 1, pages 317 - 362, ISBN 84-7738-539-4, XP009556156-
OPPOSITION- Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, "Cyclodextrins", Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 210 - 214, ISBN 978-0-85369-792-3, XP009553534-
OPPOSITION- Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, "Glycerin", Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 283 - 286, ISBN 978-0-85369-792-3, XP009553532-
OPPOSITION- Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, "Maltitol // Maltitol Solution", Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 414 - 417, ISBN 978-0-85369-792-3, XP009553537-
OPPOSITION- Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, "Polyethylene Glycol", Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 517 - 522, ISBN 978-0-85369-792-3, XP009553538-
OPPOSITION- Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, "Sorbitol", Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 679 - 682, ISBN 978-0-85369-792-3, XP055276483-
OPPOSITION- Raymond C. Rowe, "Propylene Glycol", Raymond C. Rowe, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 592 - 594, ISBN 978-0-85369-792-3, XP093153166-
OPPOSITION- ERMER et al., "Lisdexamfetamine Dimesylate: Prodrug Delivery, Amphetamine Exposure and Duration of Efficacy", Clinical Drug Invest, (20160328), vol. 36, doi:10.1007/s40261-015-0354-y, pages 341 - 356, XP055702457
OPPOSITION- Bolhuis et al. null, "Polyols as filler-binders for disintegrating tablets prepared by direct compaction", Drug Development and Industrial Pharmacy, (2009), vol. 35, doi:10.1080/03639040802587799, XP008162413
OPPOSITION- Gao Shenghua, Meng Lili, Zhao Chunjie, Zhang Tao, Qiu Pengcheng, Zhang Fuli, "Identification, Characterization and Quantification of Process-Related and Degradation Impurities in Lisdexamfetamine Dimesylate: Identifiction of Two New Compounds", Molecules, vol. 23, no. 12, doi:10.3390/molecules23123125, page 3125, XP055774061
SEARCH- ROBERT G. STRICKLEY ET AL, "Pediatric drugs-a review of commercially available oral formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, (20080501), vol. 97, no. 5, doi:10.1002/jps.21101, ISSN 0022-3549, pages 1731 - 1774, XP055121290 [A] 1-15 * the whole document *
SEARCH- COMIRAN ELOISA ET AL, "Lisdexamfetamine: A pharmacokinetic review", EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, ELSEVIER, AMSTERDAM, NL, (20160426), vol. 89, doi:10.1016/J.EJPS.2016.04.026, ISSN 0928-0987, pages 172 - 179, XP029555330 [Y] 1-15 * page 173, column 2, paragraph 1 *

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