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ZOMETA

NDA

ZOLEDRONIC ACID | N021223 | NOVARTIS PHARMACEUTICALS CORP

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7932241

Feb. 5, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS PHARMACEUTICALS CORPORATION v. AKORN, INC. 2:2013cv06835 2 patentsANDA 204935zoledronic acid	D.N.J.	2013-11-08	Terminated 2014-01-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 3 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS NCT07668583	Phase 2	Not Yet Recruiting	Assistance Publique - Hôpitaux de Paris	30	2026-09-15 → 2029-12-31
The Optimised Use of Romozosumab Study NCT06059222	Phase 4	Recruiting	University of Aarhus	270	2023-10-02 → 2032-08-31
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors NCT06625190	Phase 1/2	Recruiting	University of Florida	27	2026-02-11 → 2030-02
Trial of Parkinson's And Zoledronic Acid NCT03924414	Phase 4	Completed	California Pacific Medical Center Research Institute	2,721	2019-11-15 → 2026-02-28
Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone NCT02516423	Phase 3	Terminated	Alliance for Clinical Trials in Oncology	11	2016-11-29 → 2025-09-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain20 active DMFs7 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

NATCO PHARMA LTDZOLEDRONIC ACID

DMF 195232006

TEVA PHARMACEUTICAL INDUSTRIES LTDZOLEDRONIC ACID

DMF 197012006

JUBILANT BIOSYS LTDZOLEDRONIC ACID

DMF 200522006

SUN PHARMACEUTICAL INDUSTRIES LTDZOLEDRONIC ACID MONOHYDRATE

DMF 205742007

WOCKHARDT LTDZOLEDRONIC ACID MONOHYDRATE

DMF 210112007

DR REDDYS LABORATORIES LTDZOLEDRONIC ACID MONOHYDRATE USP

DMF 213442008

SCINOPHARM TAIWAN LTDZOLEDRONIC ACID

DMF 226882009

HIKMA PHARMACEUTICALSZOLEDRONIC ACID USP

DMF 230362009

GADOR SAZOLEDRONIC ACID

DMF 233742009

EMCURE PHARMACEUTICALS LTDZOLEDRONIC ACID USP

DMF 237682010

SHANDONG NEW TIME PHARMACEUTICAL CO LTDZOLEDRONIC ACID

DMF 238472010

ZAKLADY FARMACEUTYCZNE POLPHARMA SAZOLEDRONIC ACID MONOHYDRATE

DMF 243062010

USV PRIVATE LTDZOLEDRONIC ACID (MONOHYDRATE)

DMF 244692010

HETERO LABS LTDZOLEDRONIC ACID MONOHYDRATE

DMF 246662011

SHILPA PHARMA LIFESCIENCES LTDZOLEDRONIC ACID

DMF 259052012

MAPRIMED SAZOLEDRONIC ACID MONOHYDRATE (CODE 50787)

DMF 260672012

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDZOLEDRONIC ACID

DMF 266512012

TRIFARMA SPAZOLEDRONIC ACID

DMF 271072013

SHANDONG NEW TIME PHARMACEUTICAL CO LTDZOLEDRONIC ACID MONOHYDRATE

DMF 359342021

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDZOLEDRONIC ACID NON-STERILE DRUG SUBSTANCE

DMF 400242024

PISGAH LABS INCInactiveZOLEDRONIC ACID MONOHYDRATE (ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 189642005

CIPLA LTDInactiveZOLEDRONIC ACID

DMF 197492006

MYLAN LABORATORIES LTDInactiveZOLEDRONIC ACID

DMF 210992007

DR REDDYS LABORATORIES LTDInactiveZOLEDRONIC ACID TRIHYDRATE

DMF 213892008

IPCA LABORATORIES LTDInactiveZOLEDRONIC ACID

DMF 241192010

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDInactiveZOLEDRONIC ACID

DMF 243562010

CHEMI SPAInactiveZOLEDRONIC ACID HEMIPENTAHYDRATE

DMF 259832012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -41	View Letter (PDF)
Dec 29, 2016	SUPPL -35	View Letter (PDF)
Apr 4, 2016	SUPPL -34	View Letter (PDF)
Jun 10, 2015	SUPPL -32	View Letter (PDF)
Jan 7, 2015	SUPPL -31	View Letter (PDF)
Apr 8, 2014	SUPPL -28	View Letter (PDF)
Oct 1, 2013	SUPPL -27	View Letter (PDF)
Nov 14, 2012	SUPPL -23	View Letter (PDF)
Mar 16, 2012	SUPPL -22	View Letter (PDF)
Jan 25, 2010	SUPPL -18	View Letter (PDF)
Mar 21, 2008	SUPPL -16	View Letter (PDF)
Nov 8, 2007	SUPPL -14	View Letter (PDF)
Nov 8, 2007	SUPPL -15	View Letter (PDF)
May 26, 2006	SUPPL -12	View Letter (PDF)
Oct 14, 2005	SUPPL -11	View Letter (PDF)
Feb 3, 2005	SUPPL -10	View Letter (PDF)
Feb 3, 2005	SUPPL -9	View Letter (PDF)
Mar 28, 2004	SUPPL -8	View Letter (PDF)
Mar 2, 2004	SUPPL -6	View Letter (PDF)
Mar 26, 2003	SUPPL -4	View Letter (PDF)
Feb 22, 2002	SUPPL -3	View Letter (PDF)
Aug 20, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Aug 20, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Mar 7, 2003

#003 — EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Jun 17, 2011