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 Zoledronic Acid, Reclast. 28 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 US4939130 Substituted alkanediphosphonic acids and pharmaceutical use Sep 02, 2012

(Expired)

Sandoz
Reclast US4939130

(Pediatric)

Substituted alkanediphosphonic acids and pharmaceutical use Mar 02, 2013

(Expired)

Sandoz
Reclast US7932241 Pharmaceutical products comprising bisphosphonates Feb 05, 2028 Sandoz
Reclast US7932241

(Pediatric)

Pharmaceutical products comprising bisphosphonates Aug 05, 2028 Sandoz
Reclast US8052987 Method of administering bisphosphonates Oct 27, 2023

(Expired)

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

(Expired)

Novartis
Zometa US4939130

(Pediatric)

Substituted alkanediphosphonic acids and pharmaceutical use Mar 02, 2013

(Expired)

Novartis
Zometa US7932241 Pharmaceutical products comprising bisphosphonates Feb 05, 2028 Novartis
Zometa US8324189 Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases May 29, 2025 Novartis
Zometa US8324189

(Pediatric)

Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases Nov 29, 2025 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 03 Jun, 2019 US7932241
Payment of Maintenance Fee, 8th Year, Large Entity 25 Apr, 2019 US8052987(Litigated)
Maintenance Fee Reminder Mailed 17 Dec, 2018 US7932241
Recordation of Patent Grant Mailed 04 Dec, 2012 US8324189
Patent Issue Date Used in PTA Calculation 04 Dec, 2012 US8324189
Email Notification 15 Nov, 2012 US8324189
Issue Notification Mailed 14 Nov, 2012 US8324189



Zoledronic Acid Generics

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.


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


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


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 Prescription INTRAVENOUS AP Dec 24, 2015


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


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


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


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


14. GLAND

Gland Pharma Ltd has filed for 1 generic for Zoledronic Acid. 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 5MG BASE/100ML injectable Prescription INTRAVENOUS AP Aug 18, 2016


15. GLAND PHARMA LTD

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 Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/5ML injectable Prescription INTRAVENOUS AP Aug 5, 2013
EQ 4MG BASE/100ML

(reference standard)

injectable Prescription INTRAVENOUS AP Jun 29, 2018
EQ 5MG BASE/100ML injectable Prescription INTRAVENOUS AP Aug 8, 2019


16. 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


17. 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


18. 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


19. 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


20. 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


21. 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


22. 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


23. 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


24. 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


25. 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


26. 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