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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6828339 | Amlodipine salt forms and processes for preparing them |
Nov, 2022
(2 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 Amlodipine Besylate's patents.
Latest Legal Activities on Amlodipine Besylate's Patents
Given below is the list of recent legal activities going on the following patents of Amlodipine Besylate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 07 Jan, 2013 | US6828339 |
| Change in Power of Attorney (May Include Associate POA) Critical | 16 Apr, 2007 | US6828339 |
| Correspondence Address Change Critical | 16 Apr, 2007 | US6828339 |
| Correspondence Address Change Critical | 09 Mar, 2005 | US6828339 |
| Recordation of Patent Grant Mailed Critical | 07 Dec, 2004 | US6828339 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Dec, 2004 | US6828339 |
| Issue Notification Mailed Critical | 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Amlodipine Besylate is the generic name for the brand Amlodipine Besylate. 36 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
Alternative Brands for Amlodipine Besylate
There are several other brand drugs using the same active ingredient (Amlodipine Besylate) as 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 | ||||
|---|---|---|---|---|---|
| Adhera |
| ||||
| Boehringer Ingelheim |
| ||||
| Cmp Dev Llc |
| ||||
| Cosette |
| ||||
| Novartis |
| ||||
| Pharmacia |
| ||||
| Purple Biotech |
| ||||
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amlodipine Besylate, Amlodipine Besylate's active ingredient. Check the complete list of approved generic manufacturers for Amlodipine Besylate
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.
Approval 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 |