Oravig is a drug owned by Galt Pharmaceuticals Llc. It is protected by 3 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 Sep 11, 2022. Details of Oravig'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). | |||
| US6916485 | Prolonged release bioadhesive therapeutic systems |
Sep, 2022
(3 years ago) |
Expired
|
| US8518442 | Prolonged release bioadhesive therapeutic systems |
Sep, 2022
(3 years ago) |
Expired
|
| US7651698 | Prolonged release bioadhesive therapeutic systems |
Sep, 2022
(3 years ago) |
Expired
|
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 Oravig's patents.
Latest Legal Activities on Oravig's Patents
Given below is the list of recent legal activities going on the following patents of Oravig.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jun, 2021 | US7651698 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Jan, 2021 | US8518442 |
| Patent Issue Date Used in PTA Calculation
Critical | 27 Aug, 2013 | US8518442 |
| Recordation of Patent Grant Mailed
Critical | 27 Aug, 2013 | US8518442 |
| Email Notification
Critical | 08 Aug, 2013 | US8518442 |
| Issue Notification Mailed
Critical | 07 Aug, 2013 | US8518442 |
| Dispatch to FDC | 30 Jul, 2013 | US8518442 |
| Application Is Considered Ready for Issue
Critical | 26 Jul, 2013 | US8518442 |
| Issue Fee Payment Verified
Critical | 25 Jul, 2013 | US8518442 |
| Issue Fee Payment Received
Critical | 25 Jul, 2013 | US8518442 |
FDA has granted several exclusivities to Oravig. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Oravig, 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
Oravig.
Exclusivity Information
Oravig holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Oravig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Apr 16, 2013 |
US patents provide insights into the exclusivity only within the United States, but
Oravig 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 Oravig's family patents as well as insights into
ongoing legal events
on those patents.
Oravig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Oravig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 11, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Oravig Generics:
There are no approved generic versions for Oravig as of now.
Alternative Brands for Oravig
Oravig which is used for treating oropharyngeal candidiasis., has several other brand drugs using the same active ingredient (Miconazole). 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 | |
|---|---|---|
| Medtech Products |
| |
| Mylan |
|
About Oravig
Oravig is a drug owned by Galt Pharmaceuticals Llc. It is used for treating oropharyngeal candidiasis. Oravig uses Miconazole as an active ingredient. Oravig was launched by Galt Pharms in 2010.
Approval Date:
Oravig was approved by FDA for market use on 16 April, 2010.
Active Ingredient:
Oravig uses Miconazole as the active ingredient. Check out other Drugs and Companies using Miconazole ingredient
Treatment:
Oravig is used for treating oropharyngeal candidiasis.
Dosage:
Oravig 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 |