Epzicom is a drug owned by Viiv Healthcare Co. It is protected by 6 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 14, 2018. Details of Epzicom'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). | |||
|
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
|
|
US5905082 (Pediatric) | Crystalline oxathiolane derivatives |
Nov, 2016
(7 years ago) |
Expired
|
|
US6417191 (Pediatric) | Synergistic combinations of zidovudine, 1592U89 and 3TC |
Sep, 2016
(8 years ago) |
Expired
|
| US5905082 | Crystalline oxathiolane derivatives |
May, 2016
(8 years ago) |
Expired
|
| US6417191 | Synergistic combinations of zidovudine, 1592U89 and 3TC |
Mar, 2016
(8 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 Epzicom and ongoing litigations to help you estimate the early arrival of Epzicom generic.
Epzicom's Litigations
Epzicom been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 08, 2015, against patent number US6417191. The petitioner Teva Pharmaceuticals USA, Inc., challenged the validity of this patent, with ViiV Healthcare Co. as the respondent. Click below to track the latest information on how companies are challenging Epzicom's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6417191 | June, 2014 |
Terminated-Settled
(03 Aug, 2015) | ViiV Healthcare Co. | Apotex Corp. |
| US6417191 | January, 2015 |
Terminated-Denied
(25 Jun, 2015) | ViiV Healthcare Co. | Teva Pharmaceuticals USA, Inc. |
US patents provide insights into the exclusivity only within the United States, but Epzicom 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 Epzicom's family patents as well as insights into ongoing legal events on those patents.
Epzicom's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epzicom's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 14, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epzicom Generic API suppliers:
Abacavir Sulfate; Lamivudine is the generic name for the brand Epzicom. 7 different companies have already filed for the generic of Epzicom, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epzicom's generic
How can I launch a generic of Epzicom before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epzicom's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epzicom'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 Epzicom -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 600 mg/300 mg | 27 Sep, 2007 | 1 | 29 Sep, 2016 | 14 May, 2018 | Eligible |
Alternative Brands for Epzicom
Epzicom which is used for treating HIV infection., has several other brand drugs in the same treatment category and using the same active ingredient (Abacavir Sulfate; Lamivudine). 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||||||||||
| Agouron Pharms |
| |||||||||||||||
| Bristol Myers Squibb |
| |||||||||||||||
| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
| |||||||||||||||
| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| 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; Lamivudine. 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; Lamivudine, Epzicom's active ingredient. Check the complete list of approved generic manufacturers for Epzicom
About Epzicom
Epzicom is a drug owned by Viiv Healthcare Co. It is used for treating HIV infection. Epzicom uses Abacavir Sulfate; Lamivudine as an active ingredient. Epzicom was launched by Viiv Hlthcare in 2004.
Approval Date:
Epzicom was approved by FDA for market use on 02 August, 2004.
Active Ingredient:
Epzicom uses Abacavir Sulfate; Lamivudine as the active ingredient. Check out other Drugs and Companies using Abacavir Sulfate; Lamivudine ingredient
Treatment:
Epzicom is used for treating HIV infection.
Dosage:
Epzicom is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |