Azor is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 2 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 25, 2016. Details of Azor'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). | |||
US5616599 (Pediatric) | Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use |
Oct, 2016
(8 years ago) |
Expired
|
US5616599 | Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use |
Apr, 2016
(8 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Azor 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 Azor's family patents as well as insights into ongoing legal events on those patents.
Azor's Family Patents
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Generic Launch
Generic Release Date:
Azor's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 25, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Azor Generic API suppliers:
Amlodipine Besylate; Olmesartan Medoxomil is the generic name for the brand Azor. 13 different companies have already filed for the generic of Azor, with Accord Hlthcare Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Azor's generic
How can I launch a generic of Azor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Azor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Azor'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 Azor -
Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
---|---|---|---|---|---|
5 mg/20 mg and 10 mg/40 mg | 11 Feb, 2008 | 1 | 25 Apr, 2016 | Extinguished | |
10 mg/20 mg and 5 mg/40 mg | 31 Mar, 2008 | 1 | 25 Apr, 2016 | Extinguished |
Alternative Brands for Azor
Azor which is used for managing high blood pressure., has several other brand drugs in the same treatment category . 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 | ||||||||||||||
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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 Azor
Azor is a drug owned by Cosette Pharmaceuticals Inc. It is used for managing high blood pressure. Azor uses Amlodipine Besylate; Olmesartan Medoxomil as an active ingredient. Azor was launched by Cosette in 2007.
Approval Date:
Azor was approved by FDA for market use on 26 September, 2007.
Active Ingredient:
Azor uses Amlodipine Besylate; Olmesartan Medoxomil as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Olmesartan Medoxomil ingredient
Treatment:
Azor is used for managing high blood pressure.
Dosage:
Azor is available in tablet form for oral use. Given below is detailed information on Dosage -
Strength | Dosage Form | Availability | Application Pathway |
---|---|---|---|
EQ 5MG BASE;20MG | TABLET | Prescription | ORAL |
EQ 5MG BASE;40MG | TABLET | Prescription | ORAL |
EQ 10MG BASE;20MG | TABLET | Prescription | ORAL |
EQ 10MG BASE;40MG | TABLET | Prescription | ORAL |