Celebrex is a drug owned by Upjohn Us 2 Llc. 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 Dec 02, 2015. Details of Celebrex'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). | |||
|
US5760068 (Pediatric) | Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation |
Dec, 2015
(10 years ago) |
Expired
|
|
USRE44048 (Pediatric) | 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder |
Dec, 2015
(10 years ago) |
Expired
|
| US5760068 | Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation |
Jun, 2015
(11 years ago) |
Expired
|
| USRE44048 | 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder |
Jun, 2015
(11 years ago) |
Expired
|
|
US5563165 (Pediatric) | Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation |
May, 2014
(12 years ago) |
Expired
|
|
US5466823 (Pediatric) | Substituted pyrazolyl benzenesulfonamides |
May, 2014
(12 years ago) |
Expired
|
| US5563165 | Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation |
Nov, 2013
(12 years ago) |
Expired
|
| US5466823 | Substituted pyrazolyl benzenesulfonamides |
Nov, 2013
(12 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 Celebrex's patents.
Latest Legal Activities on Celebrex's Patents
Given below is the list of recent legal activities going on the following patents of Celebrex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 05 Mar, 2013 | USRE44048 |
| Email Notification | 14 Feb, 2013 | USRE44048 |
| Issue Notification Mailed | 13 Feb, 2013 | USRE44048 |
| Dispatch to FDC | 04 Feb, 2013 | USRE44048 |
| Email Notification | 02 Jan, 2013 | USRE44048 |
| Mail Miscellaneous Communication to Applicant | 02 Jan, 2013 | USRE44048 |
| Miscellaneous Communication to Applicant - No Action Count | 20 Dec, 2012 | USRE44048 |
| Email Notification | 09 Nov, 2012 | USRE44048 |
| Mail-Petition Decision - Granted | 02 Nov, 2012 | USRE44048 |
| Petition Decision - Granted | 01 Nov, 2012 | USRE44048 |
US patents provide insights into the exclusivity only within the United States, but
Celebrex 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 Celebrex's family patents as well as insights into
ongoing legal events
on those patents.
Celebrex's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Celebrex:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Celebrex's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 02, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Celebrex Generic API suppliers:
Celecoxib is the generic name for the brand Celebrex. 26 different companies have already filed for the generic of Celebrex, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Celebrex's generic
How can I launch a generic of Celebrex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Celebrex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Celebrex'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 Celebrex -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None | |||||
| 21 Mar, 2008 | 14 Apr, 2018 | Extinguished | 30 May, 2014 | Less |
Alternative Brands for Celebrex
Celebrex which is used for reducing inflammation and treating various types of arthritis., has several other brand drugs in the same treatment category and using the same active ingredient (Celecoxib). 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 | ||
|---|---|---|---|---|
| Azurity |
| |||
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. Celecoxib. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Carwin Pharm Assoc |
| |
| Kowa Pharms |
| |
| Purple Biotech |
| |
| Scilex Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Celecoxib, Celebrex's active ingredient. Check the complete list of approved generic manufacturers for Celebrex
About Celebrex
Celebrex is a drug owned by Upjohn Us 2 Llc. It is used for reducing inflammation and treating various types of arthritis. Celebrex uses Celecoxib as an active ingredient. Celebrex was launched by Upjohn in 1998.
Approval Date:
Celebrex was approved by FDA for market use on 31 December, 1998.
Active Ingredient:
Celebrex uses Celecoxib as the active ingredient. Check out other Drugs and Companies using Celecoxib ingredient
Treatment:
Celebrex is used for reducing inflammation and treating various types of arthritis.
Dosage:
Celebrex is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | CAPSULE | Prescription | ORAL |
| 200MG | CAPSULE | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |
| 400MG | CAPSULE | Prescription | ORAL |