Famvir is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 8 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 Mar 01, 2016. Details of Famvir'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). | |||
|
US5916893 (Pediatric) | Treatment of a latent infection of herpes virus |
Mar, 2016
(8 years ago) |
Expired
|
|
US5840763 (Pediatric) | Treatment of a latent infection of herpes viruses |
Mar, 2016
(8 years ago) |
Expired
|
| US5916893 | Treatment of a latent infection of herpes virus |
Sep, 2015
(9 years ago) |
Expired
|
| US5840763 | Treatment of a latent infection of herpes viruses |
Sep, 2015
(9 years ago) |
Expired
|
|
US6124304 (Pediatric) | Penciclovir for the treatment of zoster associated pain |
Apr, 2015
(9 years ago) |
Expired
|
|
US5866581 (Pediatric) | Penciclovir for the treatment of post therapeutic neuralgia |
Apr, 2015
(9 years ago) |
Expired
|
| US6124304 | Penciclovir for the treatment of zoster associated pain |
Oct, 2014
(10 years ago) |
Expired
|
| US5866581 | Penciclovir for the treatment of post therapeutic neuralgia |
Oct, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Famvir. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Famvir, 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 Famvir.
Exclusivity Information
Famvir holds 4 exclusivities. All of its exclusivities have expired in 2015. Details of Famvir's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-54) | Dec 24, 2012 |
| Pediatric Exclusivity(PED) | Jun 24, 2013 |
| M(M-98) | Jan 31, 2014 |
| M(M-112) | Feb 09, 2015 |
US patents provide insights into the exclusivity only within the United States, but Famvir 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 Famvir's family patents as well as insights into ongoing legal events on those patents.
Famvir's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Famvir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 01, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Famvir Generic API suppliers:
Famciclovir is the generic name for the brand Famvir. 8 different companies have already filed for the generic of Famvir, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Famvir's generic
How can I launch a generic of Famvir before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Famvir's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Famvir'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 Famvir -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 125 mg, 250 mg and 500 mg | 28 Dec, 2004 | 1 | 24 Aug, 2007 | 01 Sep, 2015 | Eligible |
About Famvir
Famvir is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating shingles infections. Famvir uses Famciclovir as an active ingredient. Famvir was launched by Novartis in 1995.
Approval Date:
Famvir was approved by FDA for market use on 11 December, 1995.
Active Ingredient:
Famvir uses Famciclovir as the active ingredient. Check out other Drugs and Companies using Famciclovir ingredient
Treatment:
Famvir is used for treating shingles infections.
Dosage:
Famvir is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |