Viread Patent Expiration

Viread is a drug owned by Gilead Sciences Inc. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2018. Details of Viread's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5977089

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US6043230

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US5922695

(Pediatric)

Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Jan, 2018

(6 years ago)

Expired
US5935946

(Pediatric)

Nucleotide analog composition and synthesis method
Jan, 2018

(6 years ago)

Expired
US5922695 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Jul, 2017

(7 years ago)

Expired
US6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jul, 2017

(7 years ago)

Expired
US5977089 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jul, 2017

(7 years ago)

Expired
US5935946 Nucleotide analog composition and synthesis method
Jul, 2017

(7 years ago)

Expired


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Viread and ongoing litigations to help you estimate the early arrival of Viread generic.

Viread's Litigations

Viread been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 04, 2014, against patent number US6043230. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Gilead Sciences, Inc. as the respondent. Click below to track the latest information on how companies are challenging Viread's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US5935946 June, 2014 Terminated-Denied
(17 Dec, 2014)
Gilead Sciences, Inc. MYLAN PHARMACEUTICALS INC.
US5922695 June, 2014 Terminated-Denied
(09 Dec, 2014)
Gilead Sciences, Inc. Mylan Pharmaceuticals Inc.
US5977089 June, 2014 Terminated-Denied
(09 Dec, 2014)
Gilead Sciences, Inc. Mylan Pharmaceuticals Inc.
US6043230 June, 2014 Terminated-Denied
(09 Dec, 2014)
Gilead Sciences, Inc. Mylan Pharmaceuticals Inc.


FDA has granted some exclusivities to Viread. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Viread, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Viread.

Exclusivity Information

Viread holds 7 exclusivities. All of its exclusivities have expired in 2017. Details of Viread's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-569) Aug 11, 2011
New Patient Population(NPP) Aug 16, 2015
Pediatric Exclusivity(PED) Sep 24, 2017
M(M-95) Oct 01, 2013
New Dosage Form(NDF) Jan 18, 2015
M(M-128) Jul 24, 2016
Orphan Drug Exclusivity(ODE) Mar 24, 2017

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Viread is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Viread's family patents as well as insights into ongoing legal events on those patents.

Viread's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Viread's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Viread Generic API suppliers:

Tenofovir Disoproxil Fumarate is the generic name for the brand Viread. 11 different companies have already filed for the generic of Viread, with Norvium Bioscience having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Viread's generic

How can I launch a generic of Viread before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Viread's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Viread's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Viread -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
300 mg 26 Jan, 2010 1 18 Mar, 2015 25 Jan, 2018 Eligible
150 mg, 200 mg, and 250 mg 17 May, 2012 1 25 Jan, 2018 Extinguished

Alternative Brands for Viread

Viread which is used for managing chronic hepatitis B and HIV infections in both adults and pediatric patients., has several other brand drugs in the same treatment category and using the same active ingredient (Tenofovir Disoproxil Fumarate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Agouron Pharms
Viracept Used for managing HIV infection.
Bristol Myers Squibb
Sustiva used for managing HIV infection in combination with other antiviral drugs.
Gilead
Truvada

(uses Tenofovir Disoproxil Fumarate)

Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences Inc
Vemlidy Used for treating chronic hepatitis B in adult and pediatric patients.
Janssen R And D
Intelence used for treating HIV-1 infection in patients who are treatment-experienced and have evidence of viral replication and resistance to certain antiretroviral drugs.
Novartis
Tyzeka Used for treating chronic hepatitis B in adult patients with evidence of viral replication and either elevated serum aminotransferases or active histological disease.
Roche
Fuzeon Used for managing HIV infection.
Viiv Hlthcare
Epivir Used for treating HIV infection.
Combivir Used for the treatment of HIV.
Trizivir Used for treating patients infected with HIV.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tenofovir Disoproxil Fumarate. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Gilead Sciences
Atripla
Gilead Sciences Inc
Complera
Stribild
Msd Merck Co
Delstrigo


Apart from brand drugs containing the same ingredient, some generics have also been filed for Tenofovir Disoproxil Fumarate, Viread's active ingredient. Check the complete list of approved generic manufacturers for Viread





About Viread

Viread is a drug owned by Gilead Sciences Inc. It is used for managing chronic hepatitis B and HIV infections in both adults and pediatric patients. Viread uses Tenofovir Disoproxil Fumarate as an active ingredient. Viread was launched by Gilead Sciences Inc in 2012.

Approval Date:

Viread was approved by FDA for market use on 18 January, 2012.

Active Ingredient:

Viread uses Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Tenofovir Disoproxil Fumarate ingredient

Treatment:

Viread is used for managing chronic hepatitis B and HIV infections in both adults and pediatric patients.

Dosage:

Viread is available in the following dosage forms - powder form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
40MG/SCOOPFUL POWDER Prescription ORAL
300MG TABLET Prescription ORAL
150MG TABLET Prescription ORAL
200MG TABLET Prescription ORAL
250MG TABLET Prescription ORAL