Sitavig is a drug owned by Lnhc Inc. It is protected by 3 US drug patents filed from 2013 to 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2030. Details of Sitavig'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). | |||
| US8592434 | Mucoadhesive buccal tablets for the treatment of orofacial herpes |
Jun, 2030
(5 years from now) | Active |
| US8747896 | Mucosal bioadhesive slow release carrier for delivering active principles |
Jun, 2027
(2 years from now) | Active |
| US8791127 | Mucosal bioadhesive slow release carrier for delivering active principles |
Mar, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Sitavig's patents.
Latest Legal Activities on Sitavig's Patents
Given below is the list of recent legal activities going on the following patents of Sitavig.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Dec, 2021 | US8791127 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Nov, 2021 | US8747896 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2021 | US8592434 |
| Mail O.P. Petition Decision | 22 Sep, 2020 | US8791127 |
| Mail O.P. Petition Decision | 22 Sep, 2020 | US8747896 |
| Email Notification Critical | 22 Sep, 2020 | US8747896 |
| Email Notification Critical | 22 Sep, 2020 | US8791127 |
| Mail-Petition Decision - Granted | 18 Sep, 2020 | US8747896 |
| Mail-Petition Decision - Granted | 17 Sep, 2020 | US8791127 |
| Petition Decision - Granted Critical | 17 Sep, 2020 | US8747896 |
FDA has granted several exclusivities to Sitavig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sitavig, 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 Sitavig.
Exclusivity Information
Sitavig holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Sitavig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 12, 2016 |
US patents provide insights into the exclusivity only within the United States, but Sitavig 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 Sitavig's family patents as well as insights into ongoing legal events on those patents.
Sitavig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sitavig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sitavig Generic API suppliers:
Acyclovir is the generic name for the brand Sitavig. 50 different companies have already filed for the generic of Sitavig, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sitavig's generic
Alternative Brands for Sitavig
Sitavig which is used for treating cold sores caused by the herpes simplex virus., has several other brand drugs using the same active ingredient (Acyclovir). 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 Acyclovir, Sitavig's active ingredient. Check the complete list of approved generic manufacturers for Sitavig
About Sitavig
Sitavig is a drug owned by Lnhc Inc. It is used for treating cold sores caused by the herpes simplex virus. Sitavig uses Acyclovir as an active ingredient. Sitavig was launched by Lnhc in 2013.
Approval Date:
Sitavig was approved by FDA for market use on 12 April, 2013.
Active Ingredient:
Sitavig uses Acyclovir as the active ingredient. Check out other Drugs and Companies using Acyclovir ingredient
Treatment:
Sitavig is used for treating cold sores caused by the herpes simplex virus.
Dosage:
Sitavig is available in tablet form for buccal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | TABLET | Prescription | BUCCAL |