Pharsight

Symtuza is owned by Janssen Prods.

Symtuza contains Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate.

Symtuza has a total of 9 drug patents out of which 1 drug patent has expired.

Expired drug patents of Symtuza are:

US7803788

Symtuza was authorised for market use on 17 July, 2018.

Symtuza is available in tablet;oral dosage forms.

Symtuza can be used as treatment of hiv-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months; treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months, tx of hiv-1 infection using a composition containing a pk enhancer that inhibits cytochrome p450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months; treatment of hiv-1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults and pediatric patients weighing at least 40kg who have no prior arv treatment history; treatment of hiv-1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults and pediatric patients weighing at least 40kg who are virologically suppressed on a stable arv regimen for at least 6 months; tx of hiv1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults & pediatric patients at least 40kg having no prior arv tx history or are virologically suppressed on a stable arv regimen for at least 6 mo; treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase in adults who have no prior antiretroviral treatment history; treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inibits cytochrome p450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months, treatment of hiv-1 infection in adult or pediatric patients (>=40 kg) with <50 copies/ml hiv-1 rna after >= 6 months on prior antiretroviral regimen and no known darunavir or tenofovir resistance-associated substitutions.

The generics of Symtuza are possible to be released after 19 July, 2038.

Application	Filing Date	Opposition Party	Legal Status
EP16180589A	2020-10-08	Cooke, Richard	Granted and Under Opposition
EP16180589A	2020-10-06	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP16180589A	2020-01-10	STADA Arzneimittel AG	Granted and Under Opposition
EP14168686A	2018-04-12	Cooke, Richard	Opposition rejected
EP13164300A	2018-01-19	Georg Kalhammer/Stephan Teipel	Granted and Under Opposition
EP13164300A	2018-01-17	Aechter, Bernd	Granted and Under Opposition
EP13164300A	2018-01-17	Cooke, Richard	Granted and Under Opposition
EP12753867A	2017-07-05	FRKelly	Granted and Under Opposition
EP12753867A	2017-07-04	Sandoz GmbH	Granted and Under Opposition
EP12753867A	2017-07-03	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP12167591A	2017-05-17	Cooke, Richard	Revoked
EP12167590A	2017-05-17	Cooke, Richard	Revoked
EP12167591A	2017-05-16	Teva Pharmaceutical Industries LTD.	Revoked
EP12167590A	2017-05-16	Teva Pharmaceutical Industries LTD.	Revoked
EP12167589A	2017-05-10	Cooke, Richard	Granted and Under Opposition
EP12167589A	2017-05-09	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP12167596A	2017-04-27	Cooke, Richard	Revoked
EP12167596A	2017-04-25	Teva Pharmaceutical Industries Ltd	Revoked
EP09739981A	2016-06-30	Cooke, Richard	Revoked
EP09739981A	2016-06-29	Teva Pharmaceutical Industries Ltd	Revoked
EP10703766A	2016-04-29	Cooke, Richard	Revoked
EP10703766A	2016-04-22	Teva Pharmaceutical Industries Ltd	Revoked
EP07836007A	2016-03-17	Trösch, Dominique	Granted and Under Opposition
EP07836007A	2016-03-17	Georg Kalhammer/Stephan Teipel	Granted and Under Opposition
EP07836007A	2016-03-16	Teva Pharmaceutical Industries LTD.	Granted and Under Opposition
EP01961695A	2015-11-25	HEXAL PHARMA AG	Patent maintained as amended
EP01961695A	2015-11-24	Strawman Limited	Patent maintained as amended
EP01961695A	2015-11-23	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP01961695A	2015-11-23	Swindell & Pearson Limited	Patent maintained as amended
EP03753571A	2015-03-18	Wittkopp, Alexander	Patent maintained as amended
EP10180831A	2015-03-18	Wittkopp, Alexander	Patent maintained as amended
EP03753571A	2015-03-17	Strawman Limited	Patent maintained as amended
EP10180831A	2015-03-17	Strawman Limited	Patent maintained as amended
EP03753571A	2015-03-06	Alfred E. Tiefenbacher (GmbH & Co. KG)	Patent maintained as amended
EP10180831A	2015-03-06	Alfred E. Tiefenbacher (GmbH & Co. KG)	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US8518987	April, 2015	Terminated-Denied	Janssen Sciences Ireland UC	Lupin Limited

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8518987	JANSSEN PRODS	Pseudopolymorphic forms of a HIV protease inhibitor	Feb, 2024 (10 months from now)
US7390791	JANSSEN PRODS	Prodrugs of phosphonate nucleotide analogues	Apr, 2025 (2 years from now)
US7700645	JANSSEN PRODS	Pseudopolymorphic forms of a HIV protease inhibitor	Dec, 2026 (3 years from now)
US8148374	JANSSEN PRODS	Modulators of pharmacokinetic properties of therapeutics	Sep, 2029 (6 years from now)
US9296769	JANSSEN PRODS	Tenofovir alafenamide hemifumarate	Aug, 2032 (9 years from now)
US8754065	JANSSEN PRODS	Tenofovir alafenamide hemifumarate	Aug, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7803788	JANSSEN PRODS	Prodrugs of phosphonate nucoleotide analogues	Feb, 2022 (1 year, 1 month ago)
US10039718	JANSSEN PRODS	Use of solid carrier particles to improve the processability of a pharmaceutical agent	Oct, 2032 (9 years from now)
US10786518	JANSSEN PRODS	Compositions and methods of treating HIV	Jul, 2038 (15 years from now)

Drugs and Companies using COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE ingredient

Market Authorisation Date: 17 July, 2018

Treatment: Treatment of hiv-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months; Treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months; Treatment of hiv-1 infection in adult or pediatric patients (>=40 kg) with <50 copies/ml hiv-1 rna after >= 6 months on prior antiretroviral regimen and no known darunavir or tenofovir resistance-associated substitutions; Tx of hiv-1 infection using a composition containing a pk enhancer that inhibits cytochrome p450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months; Treatment of hiv-1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults and pediatric patients weighing at least 40kg who have no prior arv treatment history; Treatment of hiv-1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults and pediatric patients weighing at least 40kg who are virologically suppressed on a stable arv regimen for at least 6 months; Tx of hiv1 infection using a composition containing a pk enhancer that inhibits cy p450 monoxygenase in adults & pediatric patients at least 40kg having no prior arv tx history or are virologically suppressed on a stable arv regimen for at least 6 mo; Treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase in adults who have no prior antiretroviral treatment history; Treatment of hiv-1 infection using a composition containing a pharmacokinetic enhancer that inibits cytochrome p450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months

Dosage: TABLET;ORAL