Micardis is a drug owned by Boehringer Ingelheim. It is protected by 4 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 Oct 06, 2022. Details of Micardis'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5591762 | Benzimidazoles useful as angiotensin-11 antagonists |
Jan, 2014
(10 years ago) |
Expired
|
| US6358986 | Polymorphs of telmisartan |
Jan, 2020
(4 years ago) |
Expired
|
| US7998953 | Use of inhibitors of the renin-angiotensin system |
Jun, 2020
(4 years ago) |
Expired
|
| US8003679 | Use of inhibitors of the renin-angiotensin system |
Oct, 2022
(1 year, 9 months 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 Micardis's patents.
Latest Legal Activities on Micardis's Patents
Given below is the list of recent legal activities going on the following patents of Micardis.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 25 Sep, 2023 | US8003679 |
| Expire Patent | 18 Sep, 2023 | US7998953 |
| Maintenance Fee Reminder Mailed | 10 Apr, 2023 | US8003679 |
| Maintenance Fee Reminder Mailed | 03 Apr, 2023 | US7998953 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Feb, 2019 | US8003679 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Feb, 2019 | US7998953 |
| Post Issue Communication - Certificate of Correction | 09 Feb, 2012 | US7998953 |
| Post Issue Communication - Certificate of Correction | 15 Dec, 2011 | US8003679 |
| Patent Issue Date Used in PTA Calculation | 23 Aug, 2011 | US8003679 |
| Recordation of Patent Grant Mailed | 23 Aug, 2011 | US8003679 |
FDA has granted several exclusivities to Micardis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Micardis, 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 Micardis.
Exclusivity Information
Micardis holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Micardis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-612) | Oct 16, 2012 |
Several oppositions have been filed on Micardis's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Micardis's generic, the next section provides detailed information on ongoing and past EP oppositions related to Micardis patents.
Micardis's oppositions filed in EPO
Micardis has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 06, 2006, by Speedel Pharma Ag. This opposition was filed on patent number EP98947698A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04021889A | Apr, 2008 | Merck & Co., Inc. | Revoked |
| EP04021889A | Apr, 2008 | Sanofi-Aventis Deutschland GmbH | Revoked |
| EP04021889A | Apr, 2008 | LES LABORATOIRES SERVIER | Revoked |
| EP04021889A | Apr, 2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD. | Revoked |
| EP98947698A | Feb, 2006 | Speedel Pharma AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Micardis 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 Micardis's family patents as well as insights into ongoing legal events on those patents.
Micardis's family patents
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Generic Launch
Generic Release Date:
Micardis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 06, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Micardis Generics:
Telmisartan is the generic name for the brand Micardis. 16 different companies have already filed for the generic of Micardis, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Micardis's generic
How can I launch a generic of Micardis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Micardis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Micardis'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 Micardis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 40 mg and 80 mg | 26 Dec, 2006 | 1 | 08 Jan, 2014 | 10 Jan, 2020 | Eligible |
About Micardis
Micardis is a drug owned by Boehringer Ingelheim. It is used for the treatment of cardiovascular conditions such as myocardial infarction, hypertension, and stroke. Micardis uses Telmisartan as an active ingredient. Micardis was launched by Boehringer Ingelheim in 2000.
Market Authorisation Date:
Micardis was approved by FDA for market use on 04 April, 2000.
Active Ingredient:
Micardis uses Telmisartan as the active ingredient. Check out other Drugs and Companies using Telmisartan ingredient
Treatment:
Micardis is used for the treatment of cardiovascular conditions such as myocardial infarction, hypertension, and stroke.
Dosage:
Micardis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |