Ombitasvir; paritaprevir; ritonavir - Generic Drug Details

What are the generic drug sources for ombitasvir; paritaprevir; ritonavir and what is the scope of patent protection?

Ombitasvir; paritaprevir; ritonavir is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ombitasvir; paritaprevir; ritonavir has four hundred and forty-nine patent family members in forty-eight countries.

Summary for ombitasvir; paritaprevir; ritonavir

International Patents:	449
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ombitasvir; paritaprevir; ritonavir
DailyMed Link:	ombitasvir; paritaprevir; ritonavir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ombitasvir; paritaprevir; ritonavir

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ombitasvir; paritaprevir; ritonavir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
South Valley University	Phase 4
Sohag University	Phase 4
Assiut University	Phase 4

See all ombitasvir; paritaprevir; ritonavir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ombitasvir; paritaprevir; ritonavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ombitasvir; paritaprevir; ritonavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No					Y

Expired US Patents for ombitasvir; paritaprevir; ritonavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015

EU/EMA Drug Approvals for ombitasvir; paritaprevir; ritonavir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Viekirax	ombitasvir, paritaprevir, ritonavir	EMEA/H/C/003839 Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity.	Authorised	no	no	no	2015-01-14

International Patents for ombitasvir; paritaprevir; ritonavir

Country	Patent Number	Title	Estimated Expiration
Japan	2018529671	抗ウィルス性テトラヒドロフラン誘導体
Denmark	2805726
Chile	2009001844	Forma de dosificacion farmaceutica solida que comprende lopinavir y ritonavir formulados en forma de dispersion solida o solucion solida, un polimero soluble en agua y un tensioactivo con valores de hlb de entre 4 y 10, util en el tratamiento de una infeccion por vih (divisional sol. 393-06).
European Patent Office	2853531	Composés antiviraux (Antiviral compounds)
Denmark	2954892

Supplementary Protection Certificates for ombitasvir; paritaprevir; ritonavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	207 50010-2015	Slovakia		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982/001 20150119
2692346	C201730039	Spain		PRODUCT NAME: PIBRENTASVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2368890	2015012	Norway		PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120
2368890	122015000039	Germany		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346	LUC00038	Luxembourg		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728