Patanase is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 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 Aug 02, 2023. Details of Patanase'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). | |||
|
US7977376 (Pediatric) | Olopatadine formulations for topical nasal administration |
Aug, 2023
(1 year, 9 months ago) |
Expired
|
|
US8399508 (Pediatric) | Olopatadine formulations for topical nasal administration |
Mar, 2023
(2 years ago) |
Expired
|
| US7977376 | Olopatadine formulations for topical nasal administration |
Feb, 2023
(2 years ago) |
Expired
|
| US8399508 | Olopatadine formulations for topical nasal administration |
Sep, 2022
(2 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 Patanase's patents.
Latest Legal Activities on Patanase's Patents
Given below is the list of recent legal activities going on the following patents of Patanase.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jun, 2023 | US7977376 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 23 Jun, 2023 | US7977376 |
| Maintenance Fee Reminder Mailed Critical | 27 Feb, 2023 | US7977376 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Sep, 2020 | US8399508 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Dec, 2018 | US7977376 |
| Correspondence Address Change Critical | 13 Apr, 2016 | US8399508 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Mar, 2013 | US8399508 |
| Recordation of Patent Grant Mailed Critical | 19 Mar, 2013 | US8399508 |
| Email Notification Critical | 28 Feb, 2013 | US8399508 |
| Issue Notification Mailed Critical | 27 Feb, 2013 | US8399508 |
FDA has granted several exclusivities to Patanase. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Patanase, 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 Patanase.
Exclusivity Information
Patanase holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Patanase's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Dec 01, 2012 |
| Pediatric Exclusivity(PED) | Jun 01, 2013 |
US patents provide insights into the exclusivity only within the United States, but Patanase 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 Patanase's family patents as well as insights into ongoing legal events on those patents.
Patanase's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Patanase's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 02, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Patanase Generic API suppliers:
Olopatadine Hydrochloride is the generic name for the brand Patanase. 19 different companies have already filed for the generic of Patanase, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Patanase's generic
How can I launch a generic of Patanase before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Patanase's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Patanase'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 Patanase -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.665 mg/ Spray | 29 Jun, 2009 | 1 | 08 Oct, 2014 | 18 Dec, 2010 | Extinguished |
Alternative Brands for Patanase
Patanase which is used for treating allergic rhinitis., has several other brand drugs using the same active ingredient (Olopatadine Hydrochloride). 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 | ||
|---|---|---|---|
| Alcon Labs Inc |
| ||
| Glenmark Speclt |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Olopatadine Hydrochloride, Patanase's active ingredient. Check the complete list of approved generic manufacturers for Patanase
About Patanase
Patanase is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating allergic rhinitis. Patanase uses Olopatadine Hydrochloride as an active ingredient. Patanase was launched by Novartis in 2008.
Approval Date:
Patanase was approved by FDA for market use on 15 April, 2008.
Active Ingredient:
Patanase uses Olopatadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Olopatadine Hydrochloride ingredient
Treatment:
Patanase is used for treating allergic rhinitis.
Dosage:
Patanase is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |