Epivir is a drug owned by Viiv Healthcare Co. It is protected by 4 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 Sep 20, 2018. Details of Epivir'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. | |||
| US5905082 | Crystalline oxathiolane derivatives |
May, 2016
(10 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6004968 (Pediatric) | Pharmaceutical compositions containing lamivudine |
Sep, 2018
(8 years ago) |
Expired
|
| US6004968 | Pharmaceutical compositions containing lamivudine |
Mar, 2018
(8 years ago) |
Expired
|
|
US5905082 (Pediatric) | Crystalline oxathiolane derivatives |
Nov, 2016
(9 years ago) |
Expired
|
| US5905082 | Crystalline oxathiolane derivatives |
May, 2016
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Epivir. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Epivir, 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
Epivir.
Exclusivity Information
Epivir holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Epivir'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
Epivir 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 Epivir's family patents as well as insights into
ongoing legal events
on those patents.
Epivir's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Epivir:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment | Johns Hopkins University | NA | RECRUITING
(Sep 1, 2026) | PHASE3 |
| Reducing Vertical Transmission of Hepatitis B in Africa | University of Alabama at Birmingham | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE3 |
| Lamivudine for Solid Tumors | Thomas Marron | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE1, PHASE2 |
| A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation | Icahn School of Medicine at Mount Sinai | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE1 |
| Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine | Fundacion SEIMC-GESIDA | NA | COMPLETED
(Jul 1, 2026) | PHASE2 |
| STARLITE for Unresectable High-Grade Gliomas | University of Miami | NA | RECRUITING
(Jun 1, 2026) | PHASE1 |
| Lamivudine as a Novel Clinical Effort for Rett Syndrome | Maria Denise Fernandes Carvalho de Andrade | NA | ENROLLING BY INVITATION
(Jun 1, 2026) | PHASE2 |
Generic Launch
Generic Release Date:
Epivir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 20, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epivir Generic API suppliers:
Lamivudine is the generic name for the brand Epivir. 16 different companies have already filed for the generic of Epivir, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epivir's generic
Alternative Brands for Epivir
Epivir which is used for treating HIV infection., has several other brand drugs in the same treatment category and using the same active ingredient (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 | ||||
|---|---|---|---|---|---|---|
| Agouron Pharms |
| |||||
| Bristol Myers Squibb |
| |||||
| Gilead |
| |||||
| Gilead Sciences Inc |
| |||||
| 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. Lamivudine. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||||
|---|---|---|---|---|---|
| Glaxosmithkline |
| ||||
| Merck Sharp Dohme |
| ||||
| Msd Merck Co |
| ||||
| Viiv Hlthcare |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lamivudine, Epivir's active ingredient. Check the complete list of approved generic manufacturers for Epivir
About Epivir
Epivir is a drug owned by Viiv Healthcare Co. It is used for treating HIV infection. Epivir uses Lamivudine as an active ingredient. Epivir was launched by Viiv in 1995.
Approval Date:
Epivir was approved by FDA for market use on 17 November, 1995.
Active Ingredient:
Epivir uses Lamivudine as the active ingredient. Check out other Drugs and Companies using Lamivudine ingredient
Treatment:
Epivir is used for treating HIV infection.
Dosage:
Epivir is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/ML | SOLUTION | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |