Asacol Hd is a drug owned by Abbvie Inc. It is protected by 5 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 15, 2021. Details of Asacol Hd'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). | |||
| US9089492 | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
Nov, 2021
(3 years ago) |
Expired
|
| US6893662 | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
Nov, 2021
(3 years ago) |
Expired
|
| US8580302 | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
Nov, 2021
(3 years ago) |
Expired
|
| US5541171 | Orally administrable pharmaceutical composition |
Jul, 2013
(11 years ago) |
Expired
|
| US5541170 | Orally administrable pharmaceutical compositions |
Jul, 2013
(11 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 Asacol Hd's patents.
Latest Legal Activities on Asacol Hd's Patents
Given below is the list of recent legal activities going on the following patents of Asacol Hd.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 May, 2021 | US8580302 |
| Recordation of Patent Grant Mailed Critical | 12 Nov, 2013 | US8580302 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Nov, 2013 | US8580302 |
| Issue Notification Mailed Critical | 23 Oct, 2013 | US8580302 |
| Dispatch to FDC | 18 Oct, 2013 | US8580302 |
| Mailing Corrected Notice of Allowability | 17 Oct, 2013 | US8580302 |
| Corrected Notice of Allowability | 15 Oct, 2013 | US8580302 |
| Pubs Case Remand to TC Critical | 10 Oct, 2013 | US8580302 |
| Information Disclosure Statement considered Critical | 09 Oct, 2013 | US8580302 |
| Information Disclosure Statement (IDS) Filed Critical | 09 Oct, 2013 | US8580302 |
US patents provide insights into the exclusivity only within the United States, but Asacol Hd 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 Hd's family patents as well as insights into ongoing legal events on those patents.
Asacol Hd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Asacol Hd's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 15, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Asacol Hd Generic API suppliers:
Mesalamine is the generic name for the brand Asacol Hd. 21 different companies have already filed for the generic of Asacol Hd, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Asacol Hd's generic
How can I launch a generic of Asacol Hd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Asacol Hd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Asacol Hd'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 Hd -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 800 mg | 13 Jul, 2011 | 1 | 21 Jul, 2017 | 15 Nov, 2021 | Deferred |
Alternative Brands for Asacol Hd
Asacol Hd 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 Hd's active ingredient. Check the complete list of approved generic manufacturers for Asacol Hd
About Asacol Hd
Asacol Hd is a drug owned by Abbvie Inc. It is used for treating ulcerative colitis. Asacol Hd uses Mesalamine as an active ingredient. Asacol Hd was launched by Abbvie in 2008.
Approval Date:
Asacol Hd was approved by FDA for market use on 29 May, 2008.
Active Ingredient:
Asacol Hd uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Treatment:
Asacol Hd is used for treating ulcerative colitis.
Dosage:
Asacol Hd is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |