Caduet Patent Expiration

Caduet is a drug owned by Pharmacia And Upjohn Co Llc. It is protected by 7 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 Aug 11, 2018. Details of Caduet'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).
US6455574 Therapeutic combination
Aug, 2018

(6 years ago)

Expired
US5969156

(Pediatric)

Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
Jan, 2017

(7 years ago)

Expired
US5969156 Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
Jul, 2016

(8 years ago)

Expired
US5686104

(Pediatric)

Stable oral CI-981 formulation and process of preparing same
May, 2015

(9 years ago)

Expired
US5686104 Stable oral CI-981 formulation and process of preparing same
Nov, 2014

(10 years ago)

Expired
US6126971

(Pediatric)

Stable oral CI-981 formulation and process for preparing same
Jul, 2013

(11 years ago)

Expired
US6126971 Stable oral CI-981 formulation and process for preparing same
Jan, 2013

(11 years ago)

Expired

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

Caduet's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Caduet's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 11, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Caduet Generic API suppliers:

Amlodipine Besylate; Atorvastatin Calcium is the generic name for the brand Caduet. 4 different companies have already filed for the generic of Caduet, with Dr Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Caduet's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2.5 mg/10 mg 2.5 mg/20 mg 10 mg/40 mg 17 Sep, 2009 1 29 Nov, 2013 11 Aug, 2018 Extinguished
2.5 mg/40 mg 17 Sep, 2009 1 29 Nov, 2013 11 Aug, 2018 Extinguished
5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg 29 Dec, 2006 1 11 Aug, 2018 Extinguished
5 mg/80 mg 07 Apr, 2009 1 11 Aug, 2018 Extinguished

Alternative Brands for Caduet

Caduet which is used for treating hypercholesterolemia, hyperlipidemia, and hypertension., 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
Upjohn
Lipitor Used for lowering cholesterol levels and treating high lipid levels in the blood.





About Caduet

Caduet is a drug owned by Pharmacia And Upjohn Co Llc. It is used for treating hypercholesterolemia, hyperlipidemia, and hypertension. Caduet uses Amlodipine Besylate; Atorvastatin Calcium as an active ingredient. Caduet was launched by Pharmacia in 2004.

Approval Date:

Caduet was approved by FDA for market use on 29 July, 2004.

Active Ingredient:

Caduet uses Amlodipine Besylate; Atorvastatin Calcium as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Atorvastatin Calcium ingredient

Treatment:

Caduet is used for treating hypercholesterolemia, hyperlipidemia, and hypertension.

Dosage:

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

Strength Dosage Form Availability Application Pathway
EQ 10MG BASE;EQ 40MG BASE TABLET Prescription ORAL
EQ 5MG BASE;EQ 40MG BASE TABLET Prescription ORAL
EQ 5MG BASE;EQ 10MG BASE TABLET Prescription ORAL
EQ 10MG BASE;EQ 20MG BASE TABLET Prescription ORAL
EQ 5MG BASE;EQ 80MG BASE TABLET Prescription ORAL
EQ 5MG BASE;EQ 20MG BASE TABLET Prescription ORAL
EQ 10MG BASE;EQ 80MG BASE TABLET Prescription ORAL
EQ 10MG BASE;EQ 10MG BASE TABLET Prescription ORAL
EQ 2.5MG BASE;EQ 40MG BASE TABLET Prescription ORAL
EQ 2.5MG BASE;EQ 20MG BASE TABLET Prescription ORAL
EQ 2.5MG BASE;EQ 10MG BASE TABLET Prescription ORAL