Ziagen is a drug owned by Viiv Healthcare Co. It is protected by 4 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 Aug 04, 2019. Details of Ziagen'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). | |||
|
US6641843 (Pediatric) | Pharmaceutical compositions |
Aug, 2019
(5 years ago) |
Expired
|
| US6641843 | Pharmaceutical compositions |
Feb, 2019
(5 years ago) |
Expired
|
|
US6294540 (Pediatric) | Carbocyclic nucleoside hemisulfate and its use in treating viral infections |
Nov, 2018
(6 years ago) |
Expired
|
| US6294540 | Carbocyclic nucleoside hemisulfate and its use in treating viral infections |
May, 2018
(6 years ago) |
Expired
|
FDA has granted several exclusivities to Ziagen. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ziagen, 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 Ziagen.
Exclusivity Information
Ziagen holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Ziagen's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-147) | Mar 23, 2018 |
US patents provide insights into the exclusivity only within the United States, but Ziagen 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 Ziagen's family patents as well as insights into ongoing legal events on those patents.
Ziagen's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ziagen's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 04, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ziagen Generic API suppliers:
Abacavir Sulfate is the generic name for the brand Ziagen. 6 different companies have already filed for the generic of Ziagen, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ziagen's generic
How can I launch a generic of Ziagen before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ziagen's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ziagen'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 Ziagen -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg | 28 Jan, 2009 | 1 | 18 Jun, 2012 | 14 May, 2018 | Eligible |
| 20 mg/mL | 27 Dec, 2012 | 1 | 26 Sep, 2016 | 14 May, 2018 | Eligible |
Alternative Brands for Ziagen
Ziagen which is used for the treatment of HIV/AIDS., has several other brand drugs in the same treatment category and using the same active ingredient (Abacavir 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 | ||
|---|---|---|---|---|
| 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. Abacavir Sulfate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Viiv Hlthcare |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Abacavir Sulfate, Ziagen's active ingredient. Check the complete list of approved generic manufacturers for Ziagen
About Ziagen
Ziagen is a drug owned by Viiv Healthcare Co. It is used for the treatment of HIV/AIDS. Ziagen uses Abacavir Sulfate as an active ingredient. Ziagen was launched by Viiv Hlthcare in 1998.
Approval Date:
Ziagen was approved by FDA for market use on 17 December, 1998.
Active Ingredient:
Ziagen uses Abacavir Sulfate as the active ingredient. Check out other Drugs and Companies using Abacavir Sulfate ingredient
Treatment:
Ziagen is used for the treatment of HIV/AIDS.
Dosage:
Ziagen is available in the following dosage forms - tablet form for oral use, solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/ML | SOLUTION | Prescription | ORAL |
| EQ 300MG BASE | TABLET | Discontinued | ORAL |