Rabeprazole Sodium Patent Expiration

Rabeprazole Sodium is Used for treating peptic ulcers. It was first introduced by Waylis Therapeutics Llc in its drug Aciphex on Aug 19, 1999. Another drug containing Rabeprazole Sodium is Aciphex Sprinkle. 12 different companies have introduced drugs containing Rabeprazole Sodium.


Rabeprazole Sodium Patents

Given below is the list of patents protecting Rabeprazole Sodium, 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
Aciphex US5045552

(Pediatric)

Pyridine derivatives having anti-ulcerative activity Nov 08, 2013

(Expired)

Waylis Therap
Aciphex Sprinkle US5045552

(Pediatric)

Pyridine derivatives having anti-ulcerative activity Nov 08, 2013

(Expired)

Aytu
Aciphex US5045552 Pyridine derivatives having anti-ulcerative activity May 08, 2013

(Expired)

Waylis Therap
Aciphex Sprinkle US5045552 Pyridine derivatives having anti-ulcerative activity May 08, 2013

(Expired)

Aytu



Rabeprazole Sodium's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Rabeprazole Sodium:

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
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1


Rabeprazole Sodium Generic API Manufacturers

Several generic applications have been filed for Rabeprazole Sodium. The first generic version for Rabeprazole Sodium was by Chartwell Rx Sciences Llc and was approved on Nov 8, 2013. And the latest generic version is by Alkem Laboratories Ltd and was approved on Apr 24, 2018.

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