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Amlodipine Besylate Patent Expiration

Amlodipine Besylate is a drug owned by Synthon Pharmaceuticals Inc. 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 Nov 20, 2022. Details of Amlodipine Besylate'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).
US6828339 Amlodipine salt forms and processes for preparing them
Nov, 2022

(1 year, 8 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 Amlodipine Besylate's patents.

Given below is the list of recent legal activities going on the following patents of Amlodipine Besylate.

Event Date Patent/Publication
Patent litigations
Expire Patent 07 Jan, 2013 US6828339
Change in Power of Attorney (May Include Associate POA) 16 Apr, 2007 US6828339
Correspondence Address Change 16 Apr, 2007 US6828339
Correspondence Address Change 09 Mar, 2005 US6828339
Recordation of Patent Grant Mailed 07 Dec, 2004 US6828339
Patent Issue Date Used in PTA Calculation 07 Dec, 2004 US6828339
Issue Notification Mailed 18 Nov, 2004 US6828339
Receipt into Pubs 15 Nov, 2004 US6828339
Dispatch to FDC 11 Nov, 2004 US6828339
Receipt into Pubs 05 Nov, 2004 US6828339

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US patents provide insights into the exclusivity only within the United States, but Amlodipine Besylate 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 Amlodipine Besylate's family patents as well as insights into ongoing legal events on those patents.

Amlodipine Besylate's family patents

Amlodipine Besylate has patent protection in a total of 6 countries. It's US patent count contributes only to 37.5% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Amlodipine Besylate.

Family Patents

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Generic Launch

Generic Release Date:

Amlodipine Besylate's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 20, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Amlodipine Besylate Generics:

Amlodipine Besylate is the generic name for the brand Amlodipine Besylate. 35 different companies have already filed for the generic of Amlodipine Besylate, with Invagen Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Amlodipine Besylate's generic





About Amlodipine Besylate

Amlodipine Besylate is a drug owned by Synthon Pharmaceuticals Inc. Amlodipine Besylate uses Amlodipine Besylate as an active ingredient. Amlodipine Besylate was launched by Synthon Pharms in 2007.

Market Authorisation Date:

Amlodipine Besylate was approved by FDA for market use on 27 September, 2007.

Active Ingredient:

Amlodipine Besylate uses Amlodipine Besylate as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate ingredient

Dosage:

Amlodipine Besylate is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 5MG BASE TABLET, ORALLY DISINTEGRATING Discontinued ORAL
EQ 2.5MG BASE TABLET, ORALLY DISINTEGRATING Discontinued ORAL
EQ 10MG BASE TABLET, ORALLY DISINTEGRATING Discontinued ORAL