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
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 | 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.
Latest 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 |
|---|---|---|
 | ||
| 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
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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 |
| |||||
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 |
| |||||||||||||||||
| India |
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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 |
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 |
| |||||||||||||
| Canada |
| |||||||||||||
| India |
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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 |
| |||
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 |
| |||||
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 |
| |||||||
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 |
| |||||||||||||||||
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 |
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 |
| |||||||||||||||
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 |
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 |
| |||
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 |
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 |
| |||||||||||||
| United States |
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| Dominican Republic (the) |
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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 |
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 |
| |||||
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 |
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 |
| |||
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 |
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 |
| |||||||||||
| India |
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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 |
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 |
| |||||||