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 |
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
Explore Our Curated Drug Screens
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.
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 |