Viewing data from:

DURYSTA

NDA

BIMATOPROST | N211911 | ABBVIE INC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Expiring < 1yr (3)Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Apr. 24, 2029

Apr. 7, 2027

Jul. 15, 2031

Dec. 19, 2026

Oct. 31, 2034

Oct. 31, 2034

Dec. 19, 2026

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Durysta (2023)

Total Spending

$965K

Total Claims

277

Beneficiaries

256

Avg Cost/Unit

$2044.98

Spending Trend

$42K(2020)→$217K(2021)→$698K(2022)→$965K(2023)

YoY Change:-0.4%

5yr CAGR:+0.7%

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

Medicare Part B Spending

CMS physician-administered drug spending for Durysta (2023)

Total Spending

$21.8M

Total Claims

10,696

Beneficiaries

6,616

ASP Price

—

HCPCS: J7351 — Injection, bimatoprost, intracameral implant, 1 microgram

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain13 active DMFs1 inactive

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

JOHNSON MATTHEY PHARMA SERVICESBIMATOPROST (3077.E)

DMF 209112007

CHIROGATE INTERNATIONAL INCBIMATOPROST

DMF 213822008

KYOWA PHARMA CHEMICAL CO LTDBIMATOPROST DRUG SUBSTANCE

DMF 216812008

EVERLIGHT CHEMICAL INDUSTRIAL CORPBIMATOPROST

DMF 220802008

INDUSTRIALE CHIMICA SRLBIMATOPROST

DMF 234802010

CAYMAN PHARMA SROBIMATOPROST

DMF 243532011

YS LIFE SCIENCE CO LTDBIMATOPROST

DMF 249062011

C-SQUARED PHARMA LTDBIMATOPROST

DMF 259032012

MSN LABORATORIES PRIVATE LTDBIMATOPROST [ROUTE CODE - "BM"]

DMF 270442013

SCINOPHARM TAIWAN LTDBIMATOPROST

DMF 272172013

EUROAPI HUNGARY LTDBIMATOPROST

DMF 295602015

FDC LTDBIMATOPROST USP

DMF 403502024

NEWCHEM SPABIMATOPROST

DMF 418902025

LUPIN LTDInactiveBIMATOPROST

DMF 268772013

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 11, 2024	SUPPL -2	View Letter (PDF)
Nov 4, 2020	SUPPL -1	View Letter (PDF)
Mar 5, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MCG

RLD

7 patents0 exclusivities▴

IMPLANT;OPHTHALMIC | Approved: Mar 4, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7799336	Apr 24, 2029	—	—	Yes	—	—
8206737	Apr 7, 2027	—	—	—		—
8629185	Jul 15, 2031	—	Yes	Yes	—	—
9149428	Dec 19, 2026	—	—	Yes	—	—
9492316	Oct 31, 2034	—	—	Yes	—	—
9980974	Oct 31, 2034	—	—	—		—
10441543	Dec 19, 2026	—	—	Yes	—	—