Delzicol is a drug owned by Abbvie Inc. It is protected by 3 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 13, 2020. Details of Delzicol'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). | |||
| US6649180 | Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups |
Apr, 2020
(4 years ago) |
Expired
|
| US5541170 | Orally administrable pharmaceutical compositions |
Jul, 2013
(11 years ago) |
Expired
|
| US5541171 | Orally administrable pharmaceutical composition |
Jul, 2013
(11 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Delzicol and ongoing litigations to help you estimate the early arrival of Delzicol generic.
Delzicol's Litigations
Delzicol been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 04, 2016, against patent number US6649180. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Qualicaps Co., Ltd. as the respondent. Click below to track the latest information on how companies are challenging Delzicol's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6649180 | November, 2016 |
Terminated-Settled
(19 Dec, 2017) | Qualicaps Co., Ltd. | Mylan Pharmaceuticals Inc. |
US patents provide insights into the exclusivity only within the United States, but Delzicol 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 Delzicol's family patents as well as insights into ongoing legal events on those patents.
Delzicol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Delzicol's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 13, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Delzicol Generic API suppliers:
Mesalamine is the generic name for the brand Delzicol. 21 different companies have already filed for the generic of Delzicol, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Delzicol's generic
How can I launch a generic of Delzicol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Delzicol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Delzicol'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 Delzicol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | 17 Jun, 2014 | 1 | 13 Apr, 2020 | Extinguished Non-Forfeiture |
Alternative Brands for Delzicol
Delzicol 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, Delzicol's active ingredient. Check the complete list of approved generic manufacturers for Delzicol
About Delzicol
Delzicol is a drug owned by Abbvie Inc. It is used for treating ulcerative colitis. Delzicol uses Mesalamine as an active ingredient. Delzicol was launched by Abbvie in 2013.
Approval Date:
Delzicol was approved by FDA for market use on 01 February, 2013.
Active Ingredient:
Delzicol uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Treatment:
Delzicol is used for treating ulcerative colitis.
Dosage:
Delzicol is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |