ZOLEDRONIC ACID - Generic Drug Details

What are the generic sources for zoledronic acid and what is the scope of freedom to operate?

Zoledronic acid is the generic ingredient in four branded drugs marketed by Sandoz, Gland Pharma Ltd, Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, USV, and Novartis, and is included in forty NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zoledronic acid has thirty-nine patent family members in twenty-four countries.

There are twenty-five drug master file entries for zoledronic acid. Twenty-two suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for ZOLEDRONIC ACID

International Patents:	39
US Patents:	3
Tradenames:	4
Applicants:	28
NDAs:	40
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	290
Patent Applications:	7,359
Drug Prices:	Drug price trends for ZOLEDRONIC ACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLEDRONIC ACID
What excipients (inactive ingredients) are in ZOLEDRONIC ACID?	ZOLEDRONIC ACID excipients list
DailyMed Link:	ZOLEDRONIC ACID at DailyMed

See drug prices for ZOLEDRONIC ACID

Recent Clinical Trials for ZOLEDRONIC ACID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aksaray University	Phase 4
Lund University Hospital	Phase 4
Sun Yat-sen University	Phase 3

See all ZOLEDRONIC ACID clinical trials

Generic filers with tentative approvals for ZOLEDRONIC ACID

Applicant	Application No.	Strength	Dosage Form
		4MG/5ML(0.8MG/ML)	INJECTABLE;INJECTION
		EQ 4MG BASE/5ML	INJECTABLE; IV (INFUSION)
		EQ 4MG BASE/VIAL	INJECTABLE; IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZOLEDRONIC ACID

Drug Class

Bisphosphonate

Anatomical Therapeutic Chemical (ATC) Classes for ZOLEDRONIC ACID

M05BA	Bisphosphonates
M05B	DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
M05	DRUGS FOR TREATMENT OF BONE DISEASES
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for ZOLEDRONIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOMETA	Injection	zoledronic acid	4 mg/100 mL, 100 mL vial	021223	1	2012-01-31
RECLAST	Injection	zoledronic acid	0.05 mg/mL, 100 mL vial	021817	1	2008-08-29
ZOMETA	Injection	zoledronic acid	0.8 mg (base) /mL	021223	1	2008-06-11

US Patents and Regulatory Information for ZOLEDRONIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202571-001	May 7, 2013	AP	RX	No	No
Usv	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202923-001	Sep 4, 2014	AP	RX	No	No
Meitheal	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	213371-001	Jun 5, 2023	AP	RX	No	No
Inforlife	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202828-001	Sep 23, 2013	AP	RX	No	No
Inforlife	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	203231-001	Aug 2, 2013	AP	RX	Yes	Yes

Expired US Patents for ZOLEDRONIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003

EU/EMA Drug Approvals for ZOLEDRONIC ACID

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Zoledronic Acid Accord	zoledronic acid	EMEA/H/C/002667 Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia (TIH).	Authorised	yes	no	no	2014-01-16
Actavis Group PTC ehf	Zoledronic acid Actavis	zoledronic acid	EMEA/H/C/002488 Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia.	Authorised	yes	no	no	2012-04-20
Mylan Pharmaceuticals Limited	Zoledronic acid Mylan	zoledronic acid	EMEA/H/C/002482 Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (TIH).	Authorised	yes	no	no	2012-08-23
Pfizer Europe MA EEIG	Zoledronic Acid Hospira	zoledronic acid	EMEA/H/C/002365 4 mg / 5 ml and 4 mg / 100 ml:Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia (TIH).5 mg / 100 ml:Treatment of osteoporosis:in post-menopausal women;in men;at increased risk of fracture, including those with a recent low-trauma hip fracture.Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:in post-menopausal women;in men;at increased risk of fracture.Treatment of Paget's disease of the bone in adults.	Authorised	yes	no	no	2012-11-19
Teva B.V.	Zoledronic acid Teva	zoledronic acid	EMEA/H/C/002439 Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.	Authorised	yes	no	no	2012-08-16

International Patents for ZOLEDRONIC ACID

Country	Patent Number	Title	Estimated Expiration
Israel	173766	PHARMACEUTICAL PRODUCT COMPRISING A READY TO USE ZOLEDRONIC ACID SOLUTION AND PROCESS FOR ITS PRODUCTION
South Africa	200601209	Pharmaceutical products comprising bisphosphonates
World Intellectual Property Organization (WIPO)	2005025551
Morocco	28078	PRODUITS PHARMACEUTIQUES CONTENANT DES BISPHOSPHONATES
Malaysia	141763	PHARMACEUTICAL PRODUCTS COMPRISING BISPHOSPHONATES

Supplementary Protection Certificates for ZOLEDRONIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591122	132013902140458	Italy		PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0275821	SPC/GB01/039	United Kingdom		PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
0275821	01C0035	France		PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0258618	SPC/GB01/042	United Kingdom		PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320