Travoprost - Generic Drug Details
✉ Email this page to a colleague
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 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||
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 | |||
Alcon Pharms Ltd | TRAVATAN | travoprost | SOLUTION/DROPS;OPHTHALMIC | 021257-001 | Mar 16, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apotex | TRAVOPROST | travoprost | SOLUTION/DROPS;OPHTHALMIC | 203431-001 | Jul 10, 2015 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | ||
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 | ||
Glaukos | IDOSE TR | travoprost | IMPLANT;INTRACAMERAL | 218010-001 | Dec 13, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for travoprost
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E025619 | ⤷ Try a Trial | |
Australia | 2007299727 | Self preserved aqueous pharmaceutical compositions | ⤷ Try a Trial |
Japan | 5394927 | ⤷ Try a Trial | |
European Patent Office | 2432420 | IMPLANT OCULAIRE À ÉLUTION DE MÉDICAMENT (DRUG ELUTING OCULAR IMPLANT) | ⤷ Try a Trial |
China | 101522171 | Self-preserved aqueous pharmaceutical compositions | ⤷ Try a Trial |
China | 105012964 | Pharmaceutical compositions having desirable bioavailability | ⤷ Try a Trial |
European Patent Office | 2066300 | COMPOSITIONS PHARMACEUTIQUES AQUEUSES À CONSERVATION SPONTANÉE (SELF-PRESERVED AQUEOUS PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for travoprost
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | PA2012017,C1920764 | 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 | 12C0045 | France | ⤷ Try a Trial | PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127 |
1920764 | C300540 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001-002 20011127 |
1514548 | C300671 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EG EU/1/01/199/001-002 20011128 |
1920764 | C01920764/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002 |
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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.