TRAVATAN Drug Patent Profile

Which patents cover Travatan, and when can generic versions of Travatan launch?

Travatan is a drug marketed by Alcon Pharms Ltd and Sandoz and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Travatan

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

Summary for TRAVATAN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	53
Patent Applications:	3,814
Drug Prices:	Drug price information for TRAVATAN
Drug Sales Revenues:	Drug sales revenues for TRAVATAN
DailyMed Link:	TRAVATAN at DailyMed

See drug prices for TRAVATAN

Recent Clinical Trials for TRAVATAN

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

Sponsor	Phase
The University of Hong Kong	N/A
Laboratorios Sophia S.A de C.V.	Phase 1
Novartis Pharmaceuticals	Phase 4

See all TRAVATAN clinical trials

Paragraph IV (Patent) Challenges for TRAVATAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRAVATAN	Ophthalmic Solution	travoprost	0.004%	021257	1	2008-11-28

US Patents and Regulatory Information for TRAVATAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001		DISCN	Yes	No
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT	RX	Yes	Yes			Y
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT	RX	Yes	Yes			Y
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT	RX	Yes	Yes			Y

Expired US Patents for TRAVATAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001

EU/EMA Drug Approvals for TRAVATAN

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 TRAVATAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1920764	Ester isopropylique de fluprosténol dans le traitement du glaucome et de l'hypertension oculaire (Fluprostenol isopropyl ester for use in the treatment of glaucoma and ocular hypertension)
Spain	2162951
Denmark	1514548
Australia	704670
Hong Kong	1028563

Supplementary Protection Certificates for TRAVATAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1920764	2012/033	Ireland		PRODUCT NAME: TRAVOPROST (ALSO CALLED FLUPROSTENOL ISOPROPYL ESTER); NAT REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; FIRST REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; PAEDIATRIC INVESTIGATION PLAN: P/0298/2013 PROCEEDINGS UNDER SECTION 37 OF THE PATENTS ACT, 1992 RESTORATION ORDER DATED 12TH JANUARY 2016, WAS MADE RESTORING THE PATENT MENTIONED BELOW S85583 PAUL DOYLE A RE-USABLE BAG SYSTEM RESTORATION ORDERS DATED 16TH FEBRUARY 2016, WERE MADE RESTORING THE PATENTS MENTIONED BELOW S86133 MERVYN GREENE MULTI PURPOSE TANK STAND WITH COMPLEX LOCKING MECHANISM 86119 MPC GREEN LIMITED ANEW BIN
1920764	CA 2012 00030	Denmark
1514548	PA2014029	Lithuania		PRODUCT NAME: TRAVOPROSTUM; REGISTRATION NO/DATE: EU/1/01/199/001 - EU/1/01/199/002 20011129
1920764	PA2012017	Lithuania		PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
1920764	PA2012017,C1920764	Lithuania		PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127