DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details

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

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

Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir has six hundred and eight patent family members in fifty-four countries.

Summary for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

International Patents:	608
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
DailyMed Link:	DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Dosage:

TABLET, 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.

Anatomical Therapeutic Chemical (ATC) Classes for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

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

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DASABUVIR SODIUM; 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	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No			Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No			Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No			Y	Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No

Expired US Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016

International Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Country	Patent Number	Title	Estimated Expiration
South Africa	201406351	COMBINATION TREATMENT (EG. WITH ABT-072 OR ABT -333) OF DAAAS FOR USE IN THEATING HVC
Uruguay	35259	INHIBIDORES MACROCÍCLICOS DE SERINA PROTEASAS DE HEPATITIS C
Dominican Republic	P2011000087	Compuestos eficaces para inhibir la replicación del virus de la hepatitis c("HCV")
Denmark	2583677
Hungary	E026832
Poland	2579854
Norway	2017057

Supplementary Protection Certificates for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2340029	1590012-9	Sweden		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/14/982 20150119
2203431	C02203431/01	Switzerland		BEI DER ANMELDUNG WURDE DER INHABER IRRTUEMLICH DOPPELT ERFASST.
2203431	122015000040	Germany		PRODUCT NAME: DASABUVIR; REGISTRATION NO/DATE: EU/1/14/983 20150115
2203431	CR 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2692346	300901	Netherlands		PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2692346	51/2017	Austria		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728