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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.

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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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.


1. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Jun 24, 2004





2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Jan 31, 2022
500MG

tablet Prescription ORAL AB Jan 31, 2022


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd





3. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Discontinued ORAL N/A Aug 25, 2005





4. AUROBINDO

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Aurobindo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

(reference standard)

tablet Prescription ORAL AB Jul 25, 2012
500MG

(reference standard)

tablet Prescription ORAL AB Jul 25, 2012


Manufacturing Plant Locations
New

Aurobindo's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. CHARTWELL

Chartwell Life Molecules Llc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Chartwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Aug 20, 2007
250MG

tablet Prescription ORAL AB Aug 20, 2007


Manufacturing Plant Locations
New

Chartwell's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Chartwell as present at those locations.

Country City Firm Name
United States
Carmel Chartwell Pharmaceuticals Carmel LLC
West Caldwell Chartwell Pharmaceuticals West Caldwell LLC
Richboro Chartwells Division of Compass Group / Commodities Locker
Congers Chartwell Life Sciences LLC
Congers Chartwell Pharmaceuticals LLC





6. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

(reference standard)

tablet, extended release Prescription ORAL AB May 18, 2005





7. ESJAY PHARMA

Esjay Pharma Llc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Esjay Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Jun 10, 2013
500MG

tablet Prescription ORAL AB Jun 10, 2013





8. HEC PHARM

Hec Pharm Usa Inc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Hec Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Sep 28, 2015
250MG

tablet Prescription ORAL AB Sep 28, 2015


Manufacturing Plant Locations
New

Hec Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Hec Pharm as present at those locations.

Country City Firm Name
China
Yidu HEC Pharm Co., Ltd.





9. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Discontinued ORAL N/A May 25, 2004
500MG

tablet Discontinued ORAL N/A May 25, 2004


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





10. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A May 31, 2005
250MG

tablet Discontinued ORAL N/A May 31, 2005





11. JUBILANT CADISTA

Jubilant Cadista Pharmaceuticals Inc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Jubilant Cadista.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Apr 25, 2019
250MG

tablet Discontinued ORAL N/A Apr 25, 2019


Manufacturing Plant Locations
New

Jubilant Cadista's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Jubilant Cadista as present at those locations.

Country City Firm Name
United States
Salisbury Jubilant Cadista Pharmaceuticals, Inc.





12. LUPIN LTD

Lupin Ltd has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Discontinued ORAL N/A Sep 15, 2015


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





13. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Discontinued ORAL N/A Mar 11, 2005
500MG

tablet Discontinued ORAL N/A Mar 11, 2005





14. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Feb 29, 2016





15. RANBAXY

Ranbaxy Laboratories Ltd has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Ranbaxy.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Discontinued ORAL N/A Jan 26, 2005


Manufacturing Plant Locations
New

Ranbaxy's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Ranbaxy as present at those locations.

Country City Firm Name
United States
Princeton Ranbaxy Inc.





16. SANDOZ

Sandoz Inc has filed for 4 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Aug 25, 2005
250MG

tablet Prescription ORAL AB Oct 18, 2005
250MG/5ML

(reference standard)

for suspension Prescription ORAL N/A Sep 4, 2007
125MG/5ML

for suspension Prescription ORAL N/A Sep 4, 2007


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





17. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Discontinued ORAL N/A Sep 24, 2004
250MG

tablet Discontinued ORAL N/A Sep 24, 2004
125MG/5ML

for suspension Discontinued ORAL N/A Aug 30, 2007
250MG/5ML

for suspension Discontinued ORAL N/A Aug 30, 2007





18. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 1 generic for Clarithromycin. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Jul 9, 2018


Manufacturing Plant Locations
New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country City Firm Name
United States
Maumee Sunshine Inc Of Nw Ohio
Portland Sunshine Dairy Foods Management LLC
Dublin Sunshine Mills, Inc
Glenwood Springs Sunshine & Moons, LLC
Tupelo Sunshine Mills, Inc.
Halifax Sunshine Mills, Inc.
Methuen Sunshine International Foods, Inc.
Doral Sunshine Bottling Co, Inc.
Augusta Sunshine Honey Inc.
Alhambra Sunshine Bakery
Red Bay Sunshine Mills aka World Pet Care
Andrews Sunshine Dairy, LLC
Evergreen Sunshine Honey Bees LLC
Columbus Sunshine Apiaries
Bridgeville Sunshine Burger & Specialty Food Company, LLC
Rochester Sunshine Fund Raising Co.
Artesia Sunshine Evergreen Inc.
North Las Vegas Sunshine Fresh Nevada LLC
Jacksonville Sunshine Peanut Company
Indianapolis SUNSHINE INTERNATIONAL LLC
Peru
Tambogrande Sunshine Export S.A.C
India
Surat Sunshine Global Hospital
Thailand
Tha Mai Sunshine International
China
Dongguan Sunshine Lake Pharma Co., Ltd
Mozambique
Boane Sunshine Nut Limitada





19. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Discontinued ORAL N/A May 31, 2005
500MG

tablet Discontinued ORAL N/A May 31, 2005


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Fort Dodge TEVA Animal Health Inc
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





20. WOCKHARDT

Wockhardt Ltd has filed for 2 different strengths of generic version for Clarithromycin. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Discontinued ORAL N/A May 31, 2006
500MG

tablet Discontinued ORAL N/A May 31, 2006


Manufacturing Plant Locations
New

Wockhardt's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Wockhardt as present at those locations.

Country City Firm Name
India
Aurangabad Wockhardt Limited
Solan, Nalagarh Wockhardt Limited - Baddi
Ankleshwar Wockhardt, Ltd.