Viewing data from:

ACULAR LS

NDA

KETOROLAC TROMETHAMINE | N021528 | ABBVIE INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)TodayPED (+6 mo)

2027

Today

8008338

Nov. 24, 2027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan, Inc. v. Lupin Ltd. et al 2:2011cv00530 1 patentANDA 20-2698ketorolac tromethamine ophthalmic solution, 0.4%	E.D. Tex.	2011-12-30	Terminated 2013-11-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

275 trials from ClinicalTrials.gov — 7 recruiting, 189 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Autonomic Control of the Circulation and VDR NCT03513770	Early Phase 1	Recruiting	Milton S. Hershey Medical Center	18	2019-08-14 → 2027-08-31
Post-Op Pain Control for Prophylactic Intramedullary Nailing.NCT03823534	Phase 3	Recruiting	St. Louis University	60	2019-02-20 → 2027-03-31
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery NCT04205916	Phase 4	Recruiting	Ophthalmic Consultants of Long Island	50	2019-11-04 → 2020-12-01
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery NCT04040452	Phase 4	Recruiting	Phoenix Children's Hospital	166	2021-03-01 → 2026-12-01
NSAIDs Stent Study NCT03638999	Early Phase 1	Recruiting	Washington University School of Medicine	36	2018-07-31 → 2027-10
Nonopioid Analgesia After Labral Surgery NCT03825809	Phase 2/3	Recruiting	Henry Ford Health System	100	2019-01-22 → 2020-05-20
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management NCT04130464	Phase 4	Recruiting	Ying Liu	120	2019-09-30 → 2026-12
Radiofrequency Neurotomy In Relieving Chronic Knee Pain NCT03224637	N/A	Completed	Assiut University	60	2014-07 → 2016-02
IV Ketorolac on Platelet Function Post-Cesarean Delivery NCT03805607	Phase 4	Completed	Beth Israel Deaconess Medical Center	40	2021-01-18 → 2024-03-30
Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction NCT03767036	Phase 1	Completed	Grünenthal GmbH	30	2017-06-05 → 2017-06-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$54.55

per ml

Lowest NADAC/Unit

$12.81

per ml

Brand NDCs

Generic NDCs

Avg Brand: $54.55

Avg Generic: $12.81

77% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00023927705ACULAR LS 0.4% OPHTH SOL	$54.55	ML	Brand	$12.81	2026-06-17
60758077305KETOROLAC 0.4% OPHTH SOLUTION	$12.81	ML	Generic	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$35.86

Highest Price

$241.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00023-9277-05ACULAR LS 0.4% OPH SOLN	$241.89	FSS	Abbvie US LLC	07/31/2030
00023-9277-05ACULAR LS 0.4% OPH SOLN	$211.83	Big4	Abbvie US LLC	07/31/2030
60758-0773-05KETOROLAC TROMETHAMINE 0.4% SOLN,OPH	$54.24	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
60758-0773-05KETOROLAC TROMETHAMINE 0.4% SOLN,OPH	$35.86	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Acular Ls (2024)

Total Spending

$21K

Total Claims

Beneficiaries

Avg Cost/Unit

$45.98

Spending Trend

$42K(2019)→$37K(2020)→$23K(2021)→$19K(2022)→$24K(2023)→$21K(2024)

YoY Change:-8.8%

5yr CAGR:-1.6%

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

API Supply Chain12 active DMFs8 inactive

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

QUIMICA SINTETICA SAKETOROLAC TROMETHAMINE

DMF 119801996

DR REDDYS LABORATORIES LTDKETOROLAC TROMETHAMINE USP

DMF 146031999

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAKETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 207282007

MSN LABORATORIES PRIVATE LTDKETOROLAC TROMETHAMINE USP

DMF 216932008

SHANDONG NEW TIME PHARMACEUTICAL CO LTDKETOROLAC TROMETHAMINE (NON-STERILE, BULK FORM)

DMF 224132009

SYMED LABS LTDKETOROLAC TROMETHAMINE

DMF 268702013

VASUDHA PHARMA CHEM LTDKETOROLAC TROMETHAMINE USP

DMF 290152015

EMCURE PHARMACEUTICALS LTDKETOROLAC TROMETHAMINE USP

DMF 298402015

SHANDONG NEW TIME PHARMACEUTICAL CO LTDKETOROLAC TROMETHAMINE USP

DMF 374812022

CHROMO LABORATORIES INDIA PRIVATE LTDKETOROLAC TROMETHAMINE USP

DMF 407252025

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDKETOROLAC TROMETHAMINE

DMF 407902024

QUIMICA SINTETICA SAKETOROLAC

DMF 433572025

SYNCHEM CHEMICALS PRIVATE LTDInactiveKETOROLAC TROMETHAMINE

DMF 103721993

DELMAR CHEMICALS INCInactiveKETOROLAC TROMETHAMINE

DMF 107401994

MAPRIMED SAInactiveKETOROLAC TROMETHAMINE

DMF 115071995

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveKETOROLAC TROMETHAMINE

DMF 117361995

CILAG AGInactiveKETOROLAC TROMETHAMINE

DMF 117991996

FARMAK ASInactiveKETOROLAC TROMETHAMINE

DMF 125581997

VIRCO BVBAInactiveKETOROLAC TROMETHAMINE

DMF 127821997

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveKETOROLAC TROMETHAMINE USP

DMF 142091999

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2021	SUPPL -8	View Letter (PDF)
Dec 4, 2008	SUPPL -5	View Letter (PDF)
Jun 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4%

RLD

1 patent0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 30, 2003

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8008338	May 24, 2027PED: Nov 24, 2027	PED	Yes	Yes		—