IZBA Drug Patent Profile

Which patents cover Izba, and what generic alternatives are available?

Izba is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in IZBA is travoprost. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the travoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Izba

A generic version of IZBA was approved as travoprost by CHARTWELL RX on March 1^st, 2013.

Summary for IZBA

International Patents:	39
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	3,814
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IZBA
DailyMed Link:	IZBA at DailyMed

Paragraph IV (Patent) Challenges for IZBA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IZBA	Ophthalmic Solution	travoprost	0.003%	204822	1	2015-12-30

US Patents and Regulatory Information for IZBA

IZBA is protected by four US patents.

Patents protecting IZBA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y

EU/EMA Drug Approvals for IZBA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Izba	travoprost	EMEA/H/C/002738 Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.	Authorised	no	no	no	2014-02-20
Novartis Europharm Limited	Travatan	travoprost	EMEA/H/C/000390 Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).	Authorised	no	no	no	2001-11-27

International Patents for IZBA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	124058	COMPOSICIONES FARMACÉUTICAS CON BUENA BIODISPONIBILIDAD
South Korea	101586357
Japan	5654444
Germany	202009019087
European Patent Office	2599475	Composition pharmaceutique à biodisponibilité souhaitable (Pharmaceutical composition having desirable bioavailability)

Supplementary Protection Certificates for IZBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1514548	PA2014029	Lithuania		PRODUCT NAME: TRAVOPROSTUM; REGISTRATION NO/DATE: EU/1/01/199/001 - EU/1/01/199/002 20011129
1920764	C300540	Netherlands		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001-002 20011127
1920764	SPC/GB12/038	United Kingdom		PRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
1920764	C01920764/01	Switzerland		PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002
1920764	1290027-0	Sweden		PRODUCT NAME: TRAVOPROST