Clarithromycin Patent Expiration

Clarithromycin is Used for treating mild to moderate infections caused by susceptible strains. It was first introduced by Abbvie Inc in its drug Biaxin on Oct 31, 1991. Another drug containing Clarithromycin is Biaxin Xl. 21 different companies have introduced drugs containing Clarithromycin.


Clarithromycin Patents

Given below is the list of patents protecting Clarithromycin, 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
Biaxin Xl US6551616 Extended release formulations of erythromycin derivatives Jul 15, 2017

(Expired)

Abbvie
Biaxin Xl US6010718 Extended release formulations of erythromycin derivatives Apr 11, 2017

(Expired)

Abbvie



Clarithromycin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Clarithromycin:

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
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL Hellenic Institute for the Study of Sepsis NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Clarithromycin Mechanisms in Hypersomnia Syndromes Emory University NA COMPLETED
(Jul 1, 2026)
PHASE2
Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet Reistone Biopharma Company Limited NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden The Central and Eastern European Gynecologic Oncology Group NA RECRUITING
(Jun 1, 2026)
PHASE3
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab Weill Medical College of Cornell University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease Kevin Winthrop NA RECRUITING
(May 1, 2026)
PHASE2
Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants Eli Lilly and Company NA COMPLETED
(Apr 15, 2026)
PHASE1
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor Assistance Publique - Hôpitaux de Paris NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3


Clarithromycin Generic API Manufacturers

Several generic applications have been filed for Clarithromycin. The first generic version for Clarithromycin was by Hikma Pharmaceuticals Usa Inc and was approved on May 25, 2004. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jan 31, 2022.

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