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TRAVATAN

NDA

TRAVOPROST | N021257 | ALCON PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Jubilant Life Sciences Limited FDA-2014-P-0073 · 3 docket documents Jubilant Life Sciences Limited filed this citizen petition pursuant to sections 505(b) and 505(j) of the Federal Food Drug and Cosmetic Act requesting that the FDA designate Travoprost Ophthalmic Solution, ANDA 091340 (sponsored by PAR Pharma) as the Reference Listed Drug to enable future generic ap	505(q)	2014-01-24	Withdrawn	Jubilant Life Sciences Limited
Pfizer Inc. - Citizen Petition FDA-2006-P-0072 · 9 docket documents Pfizer Inc. filed this citizen petition under 21 C.F.R. 10.30 requesting that the FDA revoke Allergan Inc.'s supplemental NDA #21-275/5-013 approval for Lumigan (bimatoprost ophthalmic solution 0.03%) for a first-line indication and deny Alcon Inc.'s supplemental NDA #21-257 for Travatan (travoprost	505(q)	2008-09-29	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

104 trials from ClinicalTrials.gov, 88 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues NCT00539526	Phase 4	Completed	Allergan	106	2007-09 → 2008-09
Divided Dose of TRAVATAN®NCT01298687	Phase 2	Completed	Alcon Research	67	2011-02 → 2011-04
A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)NCT00051155	Phase 3	Completed	Alcon Research	—	2001-01 → 2004-07
Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients NCT00288951	Phase 3	Completed	Alcon Research	690	2004-10 → 2005-06
Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy NCT01263444	Phase 4	Completed	Alcon Research	47	2011-03 → 2013-04
Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure NCT02003391	Phase 4	Completed	Alcon Research	157	2013-12 → 2015-05
Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension NCT00966940	Phase 4	Completed	Alcon Research	51	2009-09 → 2010-03
An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance NCT00329095	Phase 4	Completed	Robin, Alan L., M.D.	60	2005-12 → 2006-04
A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension NCT00527592	Phase 4	Completed	Alcon Research	54	2007-05 → 2008-08
A Study Assessing PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components for 28 Days NCT01789736	Phase 2	Completed	Aerie Pharmaceuticals	234	2013-02 → 2013-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain14 active DMFs4 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDTRAVOPROST

DMF 148902000

VERANOVA LPTRAVOPROST (3031.H)

DMF 220882008

CAYMAN PHARMA SROTRAVOPROST

DMF 222892008

CHIROGATE INTERNATIONAL INCTRAVOPROST

DMF 227382009

SIEGFRIED GRAFTON INCTRAVOPROST ACTIVE DRUG SUBSTANCE

DMF 228352009

SCINOPHARM TAIWAN LTDTRAVOPROST USP

DMF 234232009

YS LIFE SCIENCE CO LTDTRAVOPROST

DMF 249072011

DELTA BIOTECH SATRAVOPROST

DMF 261802012

LUPIN LTDTRAVOPROST USP

DMF 268782013

MSN LABORATORIES PRIVATE LTDTRAVOPROST USP [ROUTE CODE - "TS"]

DMF 278632014

CHIROGATE INTERNATIONAL INCTRAVOPROST (ISOMER FREE)

DMF 329642018

GENTEC SATRAVOPROST

DMF 343702020

EUROAPI HUNGARY LTDTRAVOPROST

DMF 347422020

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTRAVOPROST

DMF 400182024

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveTRAVOPROST

DMF 252632011

BIOCON LTDInactiveTRAVOPROST USP DRUG SUBSTANCE

DMF 257032012

PATHEON API MANUFACTURING INCInactiveTRAVOPROST, USP

DMF 284142014

EUROAPI HUNGARY LTDInactiveTRAVOPROST

DMF 294182015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 12, 2011	SUPPL -25	View Letter (PDF)
Sep 2, 2010	SUPPL -18	View Letter (PDF)
Jan 30, 2006	SUPPL -14	View Letter (PDF)
Jan 30, 2006	SUPPL -15	View Letter (PDF)
Jun 28, 2004	ORIG -1	View Letter (PDF)
Feb 27, 2004	SUPPL -12	View Letter (PDF)
Feb 27, 2004	SUPPL -13	View Letter (PDF)
Jun 8, 2003	SUPPL -10	View Letter (PDF)
Feb 13, 2003	SUPPL -9	View Letter (PDF)
Feb 13, 2003	SUPPL -6	View Letter (PDF)
Feb 13, 2003	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 16, 2001

No patent or exclusivity listings for this strength.