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SPRIX

NDA

KETOROLAC TROMETHAMINE | N022382 | COSETTE PHARMACEUTICALS INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

286 trials from ClinicalTrials.gov — 16 recruiting, 1 active, 190 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Non-Narcotic Pain Control After ACL Reconstruction NCT06973785	Phase 2	Active	The Cleveland Clinic	30	2025-07-15 → 2027-06-15
NSAIDS Following Elective Lumbar Spine Fusion NCT07743606	Phase 3	By Invitation	Rothman Institute Orthopaedics	428	2024-07-08 → 2028-12-31
Comparison of Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses Versus Non-Medicated Bandage Contact Lenses on Postoperative Pain Control After Photorefractive Keratectomy NCT07705763	N/A	Not Yet Recruiting	Madina Teaching Hospital Faisalabad	60	2026-08-01 → 2026-10-31
Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision NCT07753629	N/A	Not Yet Recruiting	Seoul National University Hospital	58	2026-08-07 → 2028-07-31
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA NCT07430085	Phase 4	Not Yet Recruiting	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	150	2026-07-31 → 2028-02-28
Examining Analgesic Synergy and Efficacy in Trauma Care NCT07435077	Phase 4	Not Yet Recruiting	Wake Forest University Health Sciences	282	2026-10 → 2027-02
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
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement NCT07487246	Phase 2	Recruiting	Rush University Medical Center	76	2026-06-29 → 2027-04-30
Autonomic Control of the Circulation and VDR NCT03513770	Early Phase 1	Recruiting	Milton S. Hershey Medical Center	18	2019-08-14 → 2027-11-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1146.22

Highest Price

$2442.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69344-0144-43SPRIX 15.75MG/SPRAY SOLN,NAS	$1146.22	Big4	Zyla Life Sciences US, LLC	07/14/2030
69344-0144-43SPRIX 15.75MG/SPRAY SOLN,NAS	$2442.25	FSS	Zyla Life Sciences US, LLC	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Sprix (2024)

Total Spending

$2.0M

Total Claims

735

Beneficiaries

191

Avg Cost/Unit

$503.55

Spending Trend

$3.3M(2019)→$2.9M(2020)→$1.5M(2021)→$1.7M(2022)→$2.2M(2023)→$2.0M(2024)

YoY Change:-4.7%

5yr CAGR:+5.7%

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

API Supply Chain13 active DMFs7 inactive

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

QUIMICA SINTETICA SAKETOROLAC TROMETHAMINE

DMF 119801996

FARMAK ASKETOROLAC TROMETHAMINE

DMF 125581997

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

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

7 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -22	View Letter (PDF)
Apr 30, 2021	SUPPL -21	View Letter (PDF)
Jan 26, 2018	SUPPL -18	View Letter (PDF)
May 10, 2016	SUPPL -12	View Letter (PDF)
May 10, 2016	SUPPL -13	View Letter (PDF)
Apr 22, 2014	SUPPL -9	View Letter (PDF)
May 21, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15.75MG/SPRAY

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: May 14, 2010

No patent or exclusivity listings for this strength.