Tiazac is a drug owned by Bausch Health Us Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 25, 2013. Details of Tiazac'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). | |||
| US5529791 | Extended release form of diltiazem |
Jun, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Tiazac 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 Tiazac's family patents as well as insights into ongoing legal events on those patents.
Tiazac's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tiazac's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 25, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tiazac Generic API suppliers:
Diltiazem Hydrochloride is the generic name for the brand Tiazac. 37 different companies have already filed for the generic of Tiazac, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tiazac's generic
How can I launch a generic of Tiazac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tiazac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tiazac'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 Tiazac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg |
Alternative Brands for Tiazac
There are several other brand drugs using the same active ingredient (Diltiazem Hydrochloride) as Tiazac. 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 | ||
|---|---|---|---|
| Bausch |
| ||
| Biovail |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diltiazem Hydrochloride, Tiazac's active ingredient. Check the complete list of approved generic manufacturers for Tiazac
About Tiazac
Tiazac is a drug owned by Bausch Health Us Llc. Tiazac uses Diltiazem Hydrochloride as an active ingredient. Tiazac was launched by Bausch in 1995.
Approval Date:
Tiazac was approved by FDA for market use on 11 September, 1995.
Active Ingredient:
Tiazac uses Diltiazem Hydrochloride as the active ingredient. Check out other Drugs and Companies using Diltiazem Hydrochloride ingredient
Dosage:
Tiazac is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 420MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 300MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 360MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 180MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 240MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 120MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |