Asacol is a drug owned by Allergan Pharmaceuticals International Ltd. 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 Jul 30, 2013. Details of Asacol'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). | |||
| US5541170 | Orally administrable pharmaceutical compositions |
Jul, 2013
(11 years ago) |
Expired
|
| US5541171 | Orally administrable pharmaceutical composition |
Jul, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Asacol 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 Asacol's family patents as well as insights into ongoing legal events on those patents.
Asacol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Asacol's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 30, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Asacol Generic API suppliers:
Mesalamine is the generic name for the brand Asacol. 21 different companies have already filed for the generic of Asacol, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Asacol's generic
How can I launch a generic of Asacol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Asacol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Asacol'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 Asacol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | 22 Jun, 2007 | 1 | 30 Jul, 2013 | Extinguished |
Alternative Brands for Asacol
Asacol which is used for treating ulcerative colitis., has several other brand drugs in the same treatment category and using the same active ingredient (Mesalamine). 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.
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. Mesalamine. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
| |
| Mylan Speciality Lp |
| |
| Salix |
| |
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mesalamine, Asacol's active ingredient. Check the complete list of approved generic manufacturers for Asacol
About Asacol
Asacol is a drug owned by Allergan Pharmaceuticals International Ltd. It is used for treating ulcerative colitis. Asacol uses Mesalamine as an active ingredient. Asacol was launched by Apil in 1992.
Approval Date:
Asacol was approved by FDA for market use on 31 January, 1992.
Active Ingredient:
Asacol uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Treatment:
Asacol is used for treating ulcerative colitis.
Dosage:
Asacol is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG | TABLET, DELAYED RELEASE | Discontinued | ORAL |