Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Colorcon
Harvard Business School
Boehringer Ingelheim
Express Scripts

Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206619

See Plans and Pricing

« Back to Dashboard

NDA 206619 describes VIEKIRA PAK (COPACKAGED), which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the VIEKIRA PAK (COPACKAGED) profile page.

The generic ingredient in VIEKIRA PAK (COPACKAGED) is dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir. One supplier is listed for this compound. Additional details are available on the dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir profile page.
Summary for 206619
Generic Entry Opportunity Date for 206619
Generic Entry Date for 206619*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 206619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619 NDA AbbVie Inc. 0074-3093 0074-3093-01 1 DOSE PACK in 1 CARTON (0074-3093-01) > 1 KIT in 1 DOSE PACK
VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619 NDA AbbVie Inc. 0074-3093 0074-3093-28 4 CARTON in 1 CARTON (0074-3093-28) > 7 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, TABLET;ORALStrengthEQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 22, 2019
Regulatory Exclusivity Use:DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1A INFECTION WITH COMPENSATED (CHILD-PUGH A) CIRRHOSIS AND GENOTYPE 1B WITH OR WITHOUT COMPENSATED (CHILD-PUGH A) CIRRHOSIS
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  See PricingPatent Expiration:Oct 18, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HCV INFECTION USING DASABUVIR

Expired US Patents for NDA 206619

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014   See Pricing   See Pricing
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014   See Pricing   See Pricing
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
McKinsey
Moodys
Boehringer Ingelheim
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.