ZOMETA Drug Patent Profile

When do Zometa patents expire, and when can generic versions of Zometa launch?

Zometa is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-nine patent family members in twenty-four countries.

The generic ingredient in ZOMETA is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zometa

A generic version of ZOMETA was approved as zoledronic acid by DR REDDYS LABS LTD on March 4^th, 2013.

Summary for ZOMETA

International Patents:	39
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	113
Patent Applications:	4,224
Drug Prices:	Drug price information for ZOMETA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOMETA
DailyMed Link:	ZOMETA at DailyMed

See drug prices for ZOMETA

Recent Clinical Trials for ZOMETA

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

Sponsor	Phase
Assiut University	Phase 3
Australian and New Zealand Intensive Care Research Centre	Phase 2
Lithuanian University of Health Sciences	N/A

See all ZOMETA clinical trials

Paragraph IV (Patent) Challenges for ZOMETA

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

US Patents and Regulatory Information for ZOMETA

ZOMETA is protected by one US patents.

Patents protecting ZOMETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001		DISCN	Yes	No
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011		DISCN	Yes	No					Y
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003		DISCN	Yes	No					Y
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011		DISCN	Yes	No			Y

Expired US Patents for ZOMETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001

EU/EMA Drug Approvals for ZOMETA

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
Sandoz Pharmaceuticals d.d.	Aclasta	zoledronic acid	EMEA/H/C/000595 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 and in men at increased risk of fracture., , Treatment of Paget's disease of the bone.,	Authorised	no	no	no	2005-04-15

International Patents for ZOMETA

See the table below for patents covering ZOMETA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6128301	Method of administering a bisphosphonate
China	100389772
New Zealand	222610	5-MEMBERED-HETEROARYL DIPHOSPHONIC ACIDS, PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS
Denmark	168820
Peru	20050468	PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS
Germany	3776880

Supplementary Protection Certificates for ZOMETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0258618	26/2001	Austria		PRODUCT NAME: ZOLEDRONSAEURE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463 20001128
0275821	27/2001	Austria		PRODUCT NAME: ZOLEDRONSAEURE UND DEREN SALZE UND HYDRATE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463.01 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	2001C/036	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NATL REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
1591122	132013902140458	Italy		PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0258618	C300059	Netherlands		PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH A ANVAARDBAAR ZOUT OF HYDRAAT OF VAN EEN FARMACOLOGISCH AANVAARDB ARE ESTER MET EEN ALKANOL MET DE FORMULE ROH, WAARIN R C1-C4 AL KYL VOORSTELT, IN HET BIJZONDER ZOLEDRONINEZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-EU/1/01/176/003 20010320