Viewing data from:

TRAVATAN Z

NDA

TRAVOPROST | N021994 | SANDOZ INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)TodayIPRPTAB Challenge

2027

2028

2029

Today

8268299

Oct. 13, 2029IPR×2

8323630

Sep. 20, 2027IPR

8388941

Sep. 20, 2027IPR

PTAB Proceedings

4 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2017-01053	8268299	IPR	Argentum Pharmaceuticals LLC et al.	Final Written Decision	2017-03-10	—
IPR2013-00428	8268299	IPR	Apotex Corp.	Terminated-Settled	2013-07-05	—
IPR2013-00429	8323630	IPR	Apotex Corp.	Terminated-Settled	2013-07-05	—
IPR2013-00430	8388941	IPR	Apotex Corp.	Terminated-Settled	2013-07-05	—

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$94.45

per ml

Lowest NADAC/Unit

$94.21

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758009575TRAVATAN Z 0.004% EYE DROP	$94.45	ML	Brand	$8.73	2026-06-17
66758009556TRAVATAN Z 0.004% EYE DROP	$94.21	ML	Brand	$8.17	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$154.89

Highest Price

$310.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66758-0095-56TRAVATAN Z 0.004% SOLN	$154.89	FSS	Sandoz, Inc.	08/14/2028
66758-0095-75TRAVATAN Z 0.004% SOLN	$310.60	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Travatan Z (2024)

Total Spending

$10.6M

Total Claims

21,212

Beneficiaries

5,919

Avg Cost/Unit

$91.83

Spending Trend

$2.1M(2020)→$19.3M(2021)→$14.9M(2022)→$12.9M(2023)→$10.6M(2024)

YoY Change:+1.4%

5yr CAGR:+6.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

6 letters from Drugs@FDA

Date	Submission	Document
Oct 10, 2025	SUPPL -20	View Letter (PDF)
Apr 3, 2020	SUPPL -13	View Letter (PDF)
Sep 26, 2017	SUPPL -12	View Letter (PDF)
Sep 12, 2011	SUPPL -6	View Letter (PDF)
Sep 2, 2010	SUPPL -1	View Letter (PDF)
Sep 25, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.004%

RLDAT2

3 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 21, 2006

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8268299	Oct 13, 2029	—	—	Yes	—	—
8323630	Sep 20, 2027	—	—	Yes	—	—
8388941	Sep 20, 2027	—	—	Yes	—	—