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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Travatan Z (2023)

Total Spending

$12.9M

Total Claims

27,916

Beneficiaries

7,534

Avg Cost/Unit

$90.60

Spending Trend

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

YoY Change:+14.3%

5yr CAGR:+7.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs3 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

CURIA WISCONSIN 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

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	—	—