Atacand Patent Expiration

Atacand is a drug owned by Ani Pharmaceuticals Inc. It is protected by 3 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 Jan 09, 2014. Details of Atacand'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).
US5534534

(Pediatric)

Pharmaceutical compositions for oral use and method of preparing them
Jan, 2014

(10 years ago)

Expired
US5534534 Pharmaceutical compositions for oral use and method of preparing them
Jul, 2013

(11 years ago)

Expired
US5196444

(Pediatric)

1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof
Dec, 2012

(12 years ago)

Expired

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

Atacand's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Atacand's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 09, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Atacand Generic API suppliers:

Candesartan Cilexetil is the generic name for the brand Atacand. 6 different companies have already filed for the generic of Atacand, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Atacand's generic

How can I launch a generic of Atacand before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Atacand's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Atacand'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 Atacand -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
4 mg, 8 mg, 16 mg and 32 mg 22 Dec, 2006 1 03 May, 2013 09 Jan, 2014 Eligible

Alternative Brands for Atacand

There are several other brand drugs using the same active ingredient (Candesartan Cilexetil) as Atacand. 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
Ani Pharms
Atacand Hct


Apart from brand drugs containing the same ingredient, some generics have also been filed for Candesartan Cilexetil, Atacand's active ingredient. Check the complete list of approved generic manufacturers for Atacand





About Atacand

Atacand is a drug owned by Ani Pharmaceuticals Inc. Atacand uses Candesartan Cilexetil as an active ingredient. Atacand was launched by Ani Pharms in 1998.

Approval Date:

Atacand was approved by FDA for market use on 04 June, 1998.

Active Ingredient:

Atacand uses Candesartan Cilexetil as the active ingredient. Check out other Drugs and Companies using Candesartan Cilexetil ingredient

Dosage:

Atacand is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
32MG TABLET Prescription ORAL
8MG TABLET Prescription ORAL
4MG TABLET Prescription ORAL
16MG TABLET Prescription ORAL