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Zoledronic Acid Patent Expiration

Zoledronic Acid is used for increasing bone mass and treating osteoporosis in postmenopausal women and men. It was first introduced by Novartis Pharmaceuticals Corp in its drug Zometa on Aug 20, 2001. Other drugs containing Zoledronic Acid are Reclast, Zoledronic Acid. 27 different companies have introduced drugs containing Zoledronic Acid.


Zoledronic Acid Patents

Given below is the list of patents protecting Zoledronic Acid, 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
Reclast US7932241

(Pediatric)

 Pharmaceutical products comprising bisphosphonates Aug 05, 2028 Sandoz
Reclast US7932241 Pharmaceutical products comprising bisphosphonates Feb 05, 2028 Sandoz
Zometa US7932241 Pharmaceutical products comprising bisphosphonates Feb 05, 2028 Novartis
Zometa US8324189

(Pediatric)

 Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases Nov 29, 2025 Novartis
Zometa US8324189 Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases May 29, 2025

(Expired)

 Novartis
Reclast US8052987 Method of administering bisphosphonates Oct 27, 2023

(Expired)

 Sandoz
Reclast US4939130

(Pediatric)

 Substituted alkanediphosphonic acids and pharmaceutical use Mar 02, 2013

(Expired)

 Sandoz
Zometa US4939130

(Pediatric)

 Substituted alkanediphosphonic acids and pharmaceutical use Mar 02, 2013

(Expired)

 Novartis
Reclast US4939130 Substituted alkanediphosphonic acids and pharmaceutical use Sep 02, 2012

(Expired)

 Sandoz
Zometa US4939130 Substituted alkanediphosphonic acids and pharmaceutical use Sep 02, 2012

(Expired)

 Novartis



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zoledronic Acid's patents.

Given below is the list recent legal activities going on the following patents of Zoledronic Acid.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 22 May, 2024 US8324189
Payment of Maintenance Fee, 12th Year, Large Entity 26 Apr, 2023 US8052987(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 21 May, 2020 US8324189
Expire Patent
Critical
 03 Jun, 2019 US7932241
Payment of Maintenance Fee, 8th Year, Large Entity 25 Apr, 2019 US8052987(Litigated)
Maintenance Fee Reminder Mailed
Critical
 17 Dec, 2018 US7932241
Recordation of Patent Grant Mailed
Critical
 04 Dec, 2012 US8324189
Patent Issue Date Used in PTA Calculation
Critical
 04 Dec, 2012 US8324189
Email Notification
Critical
 15 Nov, 2012 US8324189
Issue Notification Mailed
Critical
 14 Nov, 2012 US8324189


Zoledronic Acid's Family Patents

Family Patents

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Zoledronic Acid Generic API Manufacturers

Several generic applications have been filed for Zoledronic Acid. The first generic version for Zoledronic Acid was by Mylan Laboratories Ltd and was approved on Mar 4, 2013. And the latest generic version is by Meitheal Pharmaceuticals Inc and was approved on Jun 5, 2023.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Nov 28, 2016





2. ACTAVIS INC

Actavis Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Actavis Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Mar 4, 2013


Manufacturing Plant Locations
New

Actavis Inc'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 Actavis Inc as present at those locations.

Country City Firm Name
United States
Morristown Actavis Inc.
Mt Prospect Actavis Incorporated





3. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/100ML

injectable Prescription INTRAVENOUS AP Oct 27, 2017


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Paterson Amneal Pharmaceuticals, Llc
Branchburg Amneal Pharmaceuticals, LLC
India
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





4. APOTEX

Apotex Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/100ML

injectable Discontinued INTRAVENOUS N/A Dec 24, 2015


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Winnipeg Apotex Fermentation Inc.
Richmond Hill Apotex Inc.
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
Etobicoke Apotex, Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





5. AVET LIFESCIENCES

Avet Lifesciences Ltd has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Mar 12, 2013
EQ 5MG BASE/100ML

injectable Discontinued INTRAVENOUS N/A Mar 29, 2013





6. BPI LABS

Bpi Labs Llc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Bpi Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Dec 29, 2017


Manufacturing Plant Locations
New

Bpi Labs'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 Bpi Labs as present at those locations.

Country City Firm Name
United States
Evanston BPI Labs





7. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Mar 4, 2013


Manufacturing Plant Locations
New

Breckenridge'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 Breckenridge as present at those locations.

Country City Firm Name
United States
Boca Raton Breckenridge Pharmaceutical, Inc.
Berlin Breckenridge Pharmaceutical, Inc





8. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP May 7, 2013
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Aug 5, 2013





9. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/100ML

injectable Discontinued INTRAVENOUS N/A Nov 19, 2018





10. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

(reference standard)

injectable Prescription INTRAVENOUS AP Mar 4, 2013
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Mar 29, 2013





11. EPIC PHARMA LLC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP May 22, 2014
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Aug 21, 2014





12. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Sep 26, 2016
EQ 5MG BASE/100ML

injectable Discontinued INTRAVENOUS N/A Dec 8, 2017


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





13. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Apr 23, 2015


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC





14. GLAND

Gland Pharma Ltd has filed for 3 different strengths of generic version for Zoledronic Acid. Out of these eq 4mg base/100ml version comes by the name ZOLEDRONIC. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Aug 5, 2013
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Aug 8, 2019
EQ 4MG BASE/100ML

(reference standard)

injectable Prescription INTRAVENOUS AP Jun 29, 2018


Manufacturing Plant Locations
New

Gland'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 Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Sriperumbudur Gland Chemical Private Limited
Parawada, Visakhapatnam Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Visakhapatnam Gland Pharma Limited
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited





15. HIKMA FARMACEUTICA

Hikma Farmaceutica Sa has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Jun 3, 2013


Manufacturing Plant Locations
New

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

Country City Firm Name
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.





16. HOSPIRA

Hospira Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Mar 19, 2015


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Rocky Mount Hospira, Inc.
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Mcpherson Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





17. HOSPIRA INC

Hospira Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Hospira Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Apr 5, 2013


Manufacturing Plant Locations
New

Hospira Inc'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 Hospira Inc as present at those locations.

Country City Firm Name
United States
Lake Forest Hospira Inc
Morgan Hill Hospira Inc





18. INFORLIFE

Inforlife Sa has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Inforlife.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Sep 23, 2013


Manufacturing Plant Locations
New

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

Country City Firm Name
Switzerland
Campascio InfoRLife SA





19. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Jun 5, 2023





20. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Mar 4, 2013
EQ 5MG BASE/100ML

injectable Prescription INTRAVENOUS AP Oct 27, 2017





21. NOVAST LABS

Novast Laboratories Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Feb 19, 2020





22. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Nov 24, 2014





23. SHILPA

Shilpa Medicare Ltd has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A May 15, 2019


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Bengaluru Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited





24. SUN PHARMA GLOBAL

Sun Pharma Global Fze has filed for 2 different strengths of generic version for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Sun Pharma Global.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL

injectable Discontinued INTRAVENOUS N/A Mar 4, 2013
EQ 4MG BASE/5ML

injectable Discontinued INTRAVENOUS N/A Mar 4, 2013





25. USV

Usv Private Ltd has filed for 1 generic for Zoledronic Acid. Given below are the details of the strengths of this generic introduced by Usv.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML

injectable Prescription INTRAVENOUS AP Sep 4, 2014


Manufacturing Plant Locations
New

Usv'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 Usv as present at those locations.

Country City Firm Name
India
Takula Khed, Dist. Ratnagiri USV Private Limited
Mumbai USV Private Limited
Daman USV Private Limited