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SPRIX

NDA

KETOROLAC TROMETHAMINE | N022382 | ZYLA LIFE SCIENCES US 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Sprix (2023)

Total Spending

$2.2M

Total Claims

779

Beneficiaries

210

Avg Cost/Unit

$528.55

Spending Trend

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

YoY Change:+11.7%

5yr CAGR:+9.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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.