Reyataz Patent Expiration

Reyataz is a drug owned by Bristol Myers Squibb Co. It is protected by 4 US drug patents filed from 2014 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2019. Details of Reyataz's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US6087383 Bisulfate salt of HIV protease inhibitor
Dec, 2018

(5 years ago)

Expired
US5849911 Antivirally active heterocyclic azahexane derivatives
Jun, 2017

(7 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6087383

(Pediatric)

Bisulfate salt of HIV protease inhibitor
Jun, 2019

(5 years ago)

Expired
US6087383 Bisulfate salt of HIV protease inhibitor
Dec, 2018

(5 years ago)

Expired
US5849911

(Pediatric)

Antivirally active heterocyclic azahexane derivatives
Dec, 2017

(6 years ago)

Expired
US5849911 Antivirally active heterocyclic azahexane derivatives
Jun, 2017

(7 years ago)

Expired


FDA has granted several exclusivities to Reyataz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Reyataz, 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 Reyataz.

Exclusivity Information

Reyataz holds 5 exclusivities. All of its exclusivities have expired in 2019. Details of Reyataz's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-116) Sep 30, 2011
New Dosing Schedule(D-130) Feb 04, 2014
New Product(NP) Jun 02, 2017
New Patient Population(NPP) Sep 24, 2018
Pediatric Exclusivity(PED) Mar 24, 2019

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

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Reyataz 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 Reyataz's family patents as well as insights into ongoing legal events on those patents.

Reyataz's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Reyataz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Reyataz Generics:

Atazanavir Sulfate is the generic name for the brand Reyataz. 8 different companies have already filed for the generic of Reyataz, with Cipla having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Reyataz's generic

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

You can seek FDA approval to launch a generic drug before the expiration of Reyataz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Reyataz'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 Reyataz -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg and 150 mg 19 Mar, 2010 1 22 Apr, 2014 21 Dec, 2018 Eligible
200 mg 16 Feb, 2010 1 22 Apr, 2014 21 Dec, 2018 Eligible
300 mg 20 Jul, 2009 1 22 Apr, 2014 21 Dec, 2018 Eligible

Alternative Brands for Reyataz

Reyataz which is used for treating HIV-1 infection., has several other brand drugs in the same treatment category and using the same active ingredient (Atazanavir Sulfate). 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
Bristol
Evotaz

(uses Atazanavir Sulfate)

Used for treating HIV-1 infection by including a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase.
Bristol Myers Squibb
Zerit Xr used for managing HIV-1 infection.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Atazanavir Sulfate, Reyataz's active ingredient. Check the complete list of approved generic manufacturers for Reyataz





About Reyataz

Reyataz is a drug owned by Bristol Myers Squibb Co. It is used for treating HIV-1 infection. Reyataz uses Atazanavir Sulfate as an active ingredient. Reyataz was launched by Bristol Myers Squibb in 2014.

Approval Date:

Reyataz was approved by FDA for market use on 02 June, 2014.

Active Ingredient:

Reyataz uses Atazanavir Sulfate as the active ingredient. Check out other Drugs and Companies using Atazanavir Sulfate ingredient

Treatment:

Reyataz is used for treating HIV-1 infection.

Dosage:

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

Strength Dosage Form Availability Application Pathway
EQ 50MG BASE/PACKET POWDER Prescription ORAL
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 200MG BASE CAPSULE Prescription ORAL
EQ 300MG BASE CAPSULE Prescription ORAL