Rhinocort is a drug owned by Astrazeneca Lp. It is protected by 6 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 Oct 29, 2017. Details of Rhinocort'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). | |||
|
US6291445 (Pediatric) | Low dose budesonide formulations and uses thereof |
Oct, 2017
(7 years ago) |
Expired
|
|
US6986904 (Pediatric) | Formulation |
Oct, 2017
(7 years ago) |
Expired
|
|
US6686346 (Pediatric) | Formulation |
Oct, 2017
(7 years ago) |
Expired
|
| US6291445 | Low dose budesonide formulations and uses thereof |
Apr, 2017
(7 years ago) |
Expired
|
| US6686346 | Formulation |
Apr, 2017
(7 years ago) |
Expired
|
| US6986904 | Formulation |
Apr, 2017
(7 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 Rhinocort's patents.
Latest Legal Activities on Rhinocort's Patents
Given below is the list of recent legal activities going on the following patents of Rhinocort.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 05 Mar, 2012 | US6686346 |
| Expire Patent Critical | 15 Feb, 2010 | US6986904 |
| Post Issue Communication - Certificate of Correction | 03 Jul, 2008 | US6686346 |
| Post Issue Communication - Certificate of Correction | 23 Jun, 2008 | US6686346 |
| Post Issue Communication - Certificate of Correction | 14 Mar, 2006 | US6986904 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Jan, 2006 | US6986904 |
| Recordation of Patent Grant Mailed Critical | 17 Jan, 2006 | US6986904 |
| Issue Notification Mailed Critical | 28 Dec, 2005 | US6986904 |
| Dispatch to FDC | 12 Dec, 2005 | US6986904 |
| Application Is Considered Ready for Issue Critical | 19 Nov, 2005 | US6986904 |
US patents provide insights into the exclusivity only within the United States, but Rhinocort 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 Rhinocort's family patents as well as insights into ongoing legal events on those patents.
Rhinocort's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rhinocort's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 29, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rhinocort Generic API suppliers:
Budesonide is the generic name for the brand Rhinocort. 21 different companies have already filed for the generic of Rhinocort, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rhinocort's generic
How can I launch a generic of Rhinocort before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rhinocort's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rhinocort'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 Rhinocort -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.032 mg (32 mcg)/spray | 14 May, 2007 | 1 | 12 May, 2014 | 29 Oct, 2017 | Deferred |
Alternative Brands for Rhinocort
Rhinocort which is used for relieving symptoms of seasonal and perennial allergic rhinitis through nasal treatment., has several other brand drugs in the same treatment category and using the same active ingredient (Budesonide). 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 | ||
|---|---|---|---|---|
| Covis |
| |||
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. Budesonide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||||
|---|---|---|---|---|---|
| Astrazeneca |
| ||||
| Astrazeneca Ab |
| ||||
| Calliditas |
| ||||
| Cheplapharm |
| ||||
| Padagis Us |
| ||||
| Salix |
| ||||
| Sun Pharm Inds Inc |
| ||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Rhinocort's active ingredient. Check the complete list of approved generic manufacturers for Rhinocort
About Rhinocort
Rhinocort is a drug owned by Astrazeneca Lp. It is used for relieving symptoms of seasonal and perennial allergic rhinitis through nasal treatment. Rhinocort uses Budesonide as an active ingredient. Rhinocort was launched by Astrazeneca in 1999.
Approval Date:
Rhinocort was approved by FDA for market use on 01 October, 1999.
Active Ingredient:
Rhinocort uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Rhinocort is used for relieving symptoms of seasonal and perennial allergic rhinitis through nasal treatment.
Dosage:
Rhinocort is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.064MG/INH | SPRAY, METERED | Discontinued | NASAL |
| 0.032MG/INH | SPRAY, METERED | Prescription | NASAL |