Entocort Ec is a drug owned by Padagis Us Llc. It is protected by 2 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 Apr 29, 2019. Details of Entocort Ec'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). | |||
|
US5643602 (Pediatric) | Oral composition for the treatment of inflammatory bowel disease |
Jan, 2015
(11 years ago) |
Expired
|
| US5643602 | Oral composition for the treatment of inflammatory bowel disease |
Jul, 2014
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Entocort Ec. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Entocort Ec, 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
Entocort Ec.
Exclusivity Information
Entocort Ec holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Entocort Ec's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-178) | Apr 29, 2019 |
| New Patient Population(NPP) | Apr 29, 2019 |
US patents provide insights into the exclusivity only within the United States, but
Entocort Ec 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 Entocort Ec's family patents as well as insights into
ongoing legal events
on those patents.
Entocort Ec's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Entocort Ec:
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:
Entocort Ec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 29, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Entocort Ec Generic API suppliers:
Budesonide is the generic name for the brand Entocort Ec. 22 different companies have already filed for the generic of Entocort Ec, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Entocort Ec's generic
How can I launch a generic of Entocort Ec before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Entocort Ec's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Entocort Ec'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 Entocort Ec -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 01 Feb, 2008 | 01 Jan, 2015 | Extinguished | 02 Apr, 2014 | Less |
Alternative Brands for Entocort Ec
Entocort Ec which is used for treating and maintaining remission in mild to moderate Crohn's disease involving the ileum and/or ascending colon., has several other brand drugs 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 | |||||
|---|---|---|---|---|---|---|
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Cheplapharm |
| |||||
| Salix |
| |||||
| Sun Pharm Inds Inc |
| |||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Entocort Ec's active ingredient. Check the complete list of approved generic manufacturers for Entocort Ec
About Entocort Ec
Entocort Ec is a drug owned by Padagis Us Llc. It is used for treating and maintaining remission in mild to moderate Crohn's disease involving the ileum and/or ascending colon. Entocort Ec uses Budesonide as an active ingredient. Entocort Ec was launched by Padagis in 2001.
Approval Date:
Entocort Ec was approved by FDA for market use on 02 October, 2001.
Active Ingredient:
Entocort Ec uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Entocort Ec is used for treating and maintaining remission in mild to moderate Crohn's disease involving the ileum and/or ascending colon.
Dosage:
Entocort Ec is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |