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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |
| |||||||
| Bristol Myers Squibb |
| |||||||
| Gilead |
| |||||||
| Gilead Sciences Inc |
| |||||||
| Janssen R And D |
| |||||||
| Novartis |
| |||||||
| Roche |
| |||||||
| Viiv Hlthcare |
| |||||||
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 |
| ||
| Gilead Sciences Inc |
| ||
| Msd Merck Co |
|
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 - tablet form for oral use, powder 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 |