Tekamlo is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 1 has expired. Tekamlo's patents have been open to challenges since 06 March, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 21, 2029. Details of Tekamlo'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). | |||
| US8613949 | Galenical formulations of organic compounds |
Dec, 2029
(5 years from now) | Active |
| US5559111 | δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides |
Jul, 2018
(6 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 Tekamlo's patents.
Latest Legal Activities on Tekamlo's Patents
Given below is the list of recent legal activities going on the following patents of Tekamlo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 31 Jan, 2022 | US8613949 |
| Maintenance Fee Reminder Mailed Critical | 16 Aug, 2021 | US8613949 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Dec, 2013 | US8613949 |
| Recordation of Patent Grant Mailed Critical | 24 Dec, 2013 | US8613949 |
| Email Notification Critical | 05 Dec, 2013 | US8613949 |
| Issue Notification Mailed Critical | 04 Dec, 2013 | US8613949 |
| Application Is Considered Ready for Issue Critical | 22 Nov, 2013 | US8613949 |
| Dispatch to FDC | 22 Nov, 2013 | US8613949 |
| Issue Fee Payment Received Critical | 20 Nov, 2013 | US8613949 |
| Issue Fee Payment Verified Critical | 20 Nov, 2013 | US8613949 |
FDA has granted several exclusivities to Tekamlo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tekamlo, 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 Tekamlo.
Exclusivity Information
Tekamlo holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Tekamlo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 05, 2012 |
| New Combination(NC) | Aug 26, 2013 |
US patents provide insights into the exclusivity only within the United States, but Tekamlo 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 Tekamlo's family patents as well as insights into ongoing legal events on those patents.
Tekamlo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tekamlo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 21, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tekamlo Generics:
There are no approved generic versions for Tekamlo as of now.
Alternative Brands for Tekamlo
Tekamlo which is used for treating high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Aliskiren Hemifumarate; Amlodipine Besylate). 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 | Treatment Area | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott |
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| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
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About Tekamlo
Tekamlo is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating high blood pressure. Tekamlo uses Aliskiren Hemifumarate; Amlodipine Besylate as an active ingredient. Tekamlo was launched by Novartis in 2010.
Approval Date:
Tekamlo was approved by FDA for market use on 26 August, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tekamlo is 26 August, 2010, its NCE-1 date is estimated to be 06 March, 2011.
Active Ingredient:
Tekamlo uses Aliskiren Hemifumarate; Amlodipine Besylate as the active ingredient. Check out other Drugs and Companies using Aliskiren Hemifumarate; Amlodipine Besylate ingredient
Treatment:
Tekamlo is used for treating high blood pressure.
Dosage:
Tekamlo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE;EQ 5MG BASE | TABLET | Discontinued | ORAL |
| EQ 300MG BASE;EQ 5MG BASE | TABLET | Discontinued | ORAL |
| EQ 150MG BASE;EQ 10MG BASE | TABLET | Discontinued | ORAL |
| EQ 300MG BASE;EQ 10MG BASE | TABLET | Discontinued | ORAL |