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Last Updated: April 25, 2024

Travoprost - Generic Drug Details

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

Travoprost is the generic ingredient in five branded drugs marketed by Glaukos, Novartis, Alcon Pharms Ltd, Sandoz, Alembic, Apotex, Chartwell Rx, Micro Labs, and Mylan, and is included in nine 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-four patent family members in twenty-five countries.

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

Summary for travoprost

International Patents:	134
US Patents:	9
Tradenames:	5
Applicants:	9
NDAs:	9
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	102
Patent Applications:	6,380
Formulation / Manufacturing:	see details
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

Drug Sales Revenue Trends 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
⤷ Try a Trial	⤷ Try a Trial	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	203431-001	Jul 10, 2015	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Chartwell Rx	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	091340-001	Mar 1, 2013	AT1	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	TRAVOPROST	travoprost	SOLUTION/DROPS;OPHTHALMIC	210458-001	Dec 20, 2019	AT1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for travoprost

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	⤷ Try a Trial	⤷ Try a Trial
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	⤷ Try a Trial	⤷ Try a Trial
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001	⤷ Try a Trial	⤷ Try a Trial
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001	⤷ Try a Trial	⤷ Try a Trial
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001	⤷ Try a Trial	⤷ Try a Trial
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	⤷ Try a Trial	⤷ Try a Trial
Alcon Pharms Ltd	TRAVATAN	travoprost	SOLUTION/DROPS;OPHTHALMIC	021257-001	Mar 16, 2001	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for travoprost

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for travoprost

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Country	Patent Number	Title	Estimated Expiration
Canada	2663817	COMPOSITIONS PHARMACEUTIQUES AQUEUSES A CONSERVATION SPONTANEE (SELF-PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
European Patent Office	4282390	IMPLANTS AYANT DES CARACTÉRISTIQUES D'ADMINISTRATION DE MÉDICAMENT RÉGULÉES (IMPLANTS WITH CONTROLLED DRUG DELIVERY FEATURES)	⤷ Try a Trial
Argentina	062929	COMPOSICIONES FARMACEUTICAS ACUOSAS AUTOCONSERVADAS	⤷ Try a Trial
Canada	2930390	IMPLANTS OCULAIRES CONCUS POUR STOCKER ET LIBERER DES FORMULATIONS DE MEDICAMENTS STABLES (OCULAR IMPLANTS CONFIGURED TO STORE AND RELEASE STABLE DRUG FORMULATIONS)	⤷ Try a Trial
Canada	2606370	PREPARATIONS PHARMACEUTIQUES AQUEUSES A AUTO-CONSERVATION (SELF-PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
Canada	2762536	IMPLANT OCULAIRE A ELUTION DE MEDICAMENT (DRUG ELUTING OCULAR IMPLANT)	⤷ Try a Trial
Hong Kong	1212605	具有所需生物利用度的藥物組合物 (PHARMACEUTICAL COMPOSITIONS HAVING DESIRABLE BIOAVAILABILITY)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for travoprost

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1920764	C01920764/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002
1920764	PA2012017	Lithuania	⤷ Try a Trial	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	2012/033	Ireland	⤷ Try a Trial	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	1290027-0	Sweden	⤷ Try a Trial	PRODUCT NAME: TRAVOPROST
1920764	SPC/GB12/038	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
1514548	PA2014029	Lithuania	⤷ Try a Trial	PRODUCT NAME: TRAVOPROSTUM; REGISTRATION NO/DATE: EU/1/01/199/001 - EU/1/01/199/002 20011129
1514548	CA 2014 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: TRAVOPROST; REG. NO/DATE: EU/1/01/199/001-002 20011127
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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