Lipitor is a drug owned by Upjohn Manufacturing Ireland Unltd. It is protected by 6 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 Jun 23, 2020. Details of Lipitor'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). | |||
|
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
|
FDA has granted several exclusivities to Lipitor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lipitor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lipitor.
Exclusivity Information
Lipitor holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Lipitor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-204) | Jun 23, 2020 |
US patents provide insights into the exclusivity only within the United States, but Lipitor 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 Lipitor's family patents as well as insights into ongoing legal events on those patents.
Lipitor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lipitor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 23, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lipitor Generic API suppliers:
Atorvastatin Calcium is the generic name for the brand Lipitor. 31 different companies have already filed for the generic of Lipitor, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lipitor's generic
How can I launch a generic of Lipitor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lipitor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lipitor'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 Lipitor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 20 mg, 40 mg and 80 mg |
Alternative Brands for Lipitor
Lipitor which is used for lowering cholesterol levels and treating high lipid levels in the blood., has several other brand drugs in the same treatment category and using the same active ingredient (Atorvastatin Calcium). 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 | ||
|---|---|---|---|---|
| Pharmacia |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Atorvastatin Calcium. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Atorvastatin Calcium, Lipitor's active ingredient. Check the complete list of approved generic manufacturers for Lipitor
About Lipitor
Lipitor is a drug owned by Upjohn Manufacturing Ireland Unltd. It is used for lowering cholesterol levels and treating high lipid levels in the blood. Lipitor uses Atorvastatin Calcium as an active ingredient. Lipitor was launched by Upjohn in 1996.
Approval Date:
Lipitor was approved by FDA for market use on 17 December, 1996.
Active Ingredient:
Lipitor uses Atorvastatin Calcium as the active ingredient. Check out other Drugs and Companies using Atorvastatin Calcium ingredient
Treatment:
Lipitor is used for lowering cholesterol levels and treating high lipid levels in the blood.
Dosage:
Lipitor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET | Prescription | ORAL |
| EQ 80MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |