Atorvastatin Calcium Patent Expiration

Atorvastatin Calcium is used for reducing LDL-C levels in patients with homozygous familial hypercholesterolemia. It was first introduced by Upjohn Manufacturing Ireland Unltd in its drug Lipitor on Dec 17, 1996. Another drug containing Atorvastatin Calcium is Atorvaliq. 34 different companies have introduced drugs containing Atorvastatin Calcium.


Atorvastatin Calcium Patents

Given below is the list of patents protecting Atorvastatin Calcium, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Atorvaliq US11369567 Aqueous suspension suitable for oral administration Jun 07, 2037 Cmp Dev Llc
Atorvaliq US11654106 Aqueous suspension suitable for oral administration Jun 07, 2037 Cmp Dev Llc
Atorvaliq US11925704 Aqueous suspension suitable for oral administration Jun 07, 2037 Cmp Dev Llc
Atorvaliq US12168069 Aqueous suspension suitable for oral administration Jun 07, 2037 Cmp Dev Llc
Atorvaliq US12370136 Aqueous Suspension Suitable For Oral Administration Jun 07, 2037 Cmp Dev Llc
Atorvaliq US12599553 Aqueous Suspension Suitable For Oral Administration Jun 07, 2037 Cmp Dev Llc
Lipitor 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 08, 2017

(Expired)

Upjohn
Lipitor 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 08, 2016

(Expired)

Upjohn
Lipitor US5686104

(Pediatric)

Stable oral CI-981 formulation and process of preparing same May 11, 2015

(Expired)

Upjohn
Lipitor US5686104 Stable oral CI-981 formulation and process of preparing same Nov 11, 2014

(Expired)

Upjohn
Lipitor US6126971

(Pediatric)

Stable oral CI-981 formulation and process for preparing same Jul 19, 2013

(Expired)

Upjohn
Lipitor US6126971 Stable oral CI-981 formulation and process for preparing same Jan 19, 2013

(Expired)

Upjohn



Atorvastatin Calcium's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Atorvastatin Calcium:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity The United Bio-Technology (Hengqin) Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1
PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC Cancer Institute and Hospital, Chinese Academy of Medical Sciences NA NOT YET RECRUITING
(May 1, 2026)
PHASE1, PHASE2


Atorvastatin Calcium Generic API Manufacturers

Several generic applications have been filed for Atorvastatin Calcium. The first generic version for Atorvastatin Calcium was by Sun Pharmaceutical Industries Ltd and was approved on Nov 30, 2011. And the latest generic version is by Teva Pharmaceuticals Inc and was approved on Nov 13, 2025.

Given below is the list of companies who have filed for Atorvastatin Calcium generic, along with the locations of their manufacturing plants worldwide.