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Last Updated: December 1, 2020

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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 four branded drugs marketed by Novartis, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex, Mylan, and Par Pharm, and is included in seven NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Travoprost has eighty-two patent family members in twenty-five countries.

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

Drug Prices for travoprost

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Drug Sales Revenue Trends for travoprost

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Recent Clinical Trials for travoprost

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

SponsorPhase
Assiut UniversityPhase 4
Laboratorios Sophia S.A de C.V.Phase 1
Glaukos CorporationPhase 3

See all travoprost clinical trials

Generic filers with tentative approvals for TRAVOPROST
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.004%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
Medical Subject Heading (MeSH) Categories for travoprost
Paragraph IV (Patent) Challenges for TRAVOPROST
Tradename Dosage Ingredient NDA Submissiondate
IZBA SOLUTION/DROPS;OPHTHALMIC travoprost 204822 2015-12-30
TRAVATAN Z SOLUTION/DROPS;OPHTHALMIC travoprost 021994 2009-02-19
TRAVATAN SOLUTION/DROPS;OPHTHALMIC travoprost 021257 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
Par Pharm TRAVOPROST travoprost SOLUTION/DROPS;OPHTHALMIC 091340-001 Mar 1, 2013 AT1 RX No Yes   Start Trial   Start Trial   Start Trial
Novartis IZBA travoprost SOLUTION/DROPS;OPHTHALMIC 204822-001 May 15, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Alembic Pharms Ltd TRAVOPROST travoprost SOLUTION/DROPS;OPHTHALMIC 210458-001 Dec 20, 2019 AT1 RX No No   Start Trial   Start Trial   Start Trial
Novartis IZBA travoprost SOLUTION/DROPS;OPHTHALMIC 204822-001 May 15, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apotex TRAVOPROST travoprost SOLUTION/DROPS;OPHTHALMIC 203431-001 Jul 10, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006 AT RX Yes Yes   Start Trial   Start Trial Y   Start 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

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

Supplementary Protection Certificates for travoprost

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1920764 PA2012017 Lithuania   Start 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 12C0045 France   Start Trial PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
1514548 CA 2014 00038 Denmark   Start Trial PRODUCT NAME: TRAVOPROST; REG. NO/DATE: EU/1/01/199/001-002 20011127
1920764 PA2012017,C1920764 Lithuania   Start 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   Start 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   Start Trial PRODUCT NAME: TRAVOPROST
1514548 PA2014029 Lithuania   Start Trial PRODUCT NAME: TRAVOPROSTUM; REGISTRATION NO/DATE: EU/1/01/199/001 - EU/1/01/199/002 20011129
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
Mallinckrodt
Boehringer Ingelheim

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