TRAVOPROST - Generic Drug Details

What are the generic sources for travoprost and what is the scope of patent protection?

Travoprost is the generic ingredient in five branded drugs marketed by Glaukos, Novartis, Alcon Pharms Ltd, Sandoz, Alembic, Apotex, Chartwell Rx, Gland Pharma Ltd, Lupin Ltd, Micro Labs, Mylan, and Somerset Theraps Llc, and is included in twelve NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Travoprost has one hundred and thirty-six patent family members in twenty-five countries.

There are fifteen drug master file entries for travoprost. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for TRAVOPROST

International Patents:	136
US Patents:	9
Tradenames:	5
Applicants:	12
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	105
Patent Applications:	5,857
Drug Prices:	Drug price trends for TRAVOPROST
Drug Sales Revenues:	Drug sales revenues for TRAVOPROST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRAVOPROST
What excipients (inactive ingredients) are in TRAVOPROST?	TRAVOPROST excipients list
DailyMed Link:	TRAVOPROST at DailyMed

See drug prices for TRAVOPROST

See drug sales revenues for TRAVOPROST

Recent Clinical Trials for TRAVOPROST

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

Sponsor	Phase
Salus University	Phase 4
Assiut University	Phase 4
Glaukos Corporation	Phase 3

See all TRAVOPROST clinical trials

Generic filers with tentative approvals for TRAVOPROST

Applicant	Application No.	Strength	Dosage Form
		0.004%	SOLUTION; OPHTHALMIC

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 TRAVOPROST

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for TRAVOPROST

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for TRAVOPROST

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for TRAVOPROST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IZBA	Ophthalmic Solution	travoprost	0.003%	204822	1	2015-12-30
TRAVATAN Z	Ophthalmic Solution	travoprost	0.004%	021994	1	2009-02-19
TRAVATAN	Ophthalmic Solution	travoprost	0.004%	021257	1	2008-11-28

US Patents and Regulatory Information for TRAVOPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	210458-001	Dec 20, 2019	AT1	RX	No	No
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Mylan	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	205050-001	Jul 7, 2017	AT	RX	No	No
Somerset Theraps Llc	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	217228-001	Sep 23, 2024	AT	RX	No	No

Expired US Patents for TRAVOPROST

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
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006

EU/EMA Drug Approvals for TRAVOPROST

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 TRAVOPROST

Country	Patent Number	Title	Estimated Expiration
Japan	2015171553	薬剤溶出眼内インプラント (DRUG ELUTING OCULAR IMPLANT)
Argentina	062929	COMPOSICIONES FARMACEUTICAS ACUOSAS AUTOCONSERVADAS
South Africa	200901702	Self-preserved aqueous pharmaceutical compositions
European Patent Office	2599475	Composition pharmaceutique à biodisponibilité souhaitable (Pharmaceutical composition having desirable bioavailability)

Supplementary Protection Certificates for TRAVOPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1514548	PA2014029	Lithuania		PRODUCT NAME: TRAVOPROSTUM; REGISTRATION NO/DATE: EU/1/01/199/001 - EU/1/01/199/002 20011129
1920764	1290027-0	Sweden		PRODUCT NAME: TRAVOPROST
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