Viewing data from:

ACUVAIL

NDA

KETOROLAC TROMETHAMINE | N022427 | ABBVIE INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

Today

7842714

Aug. 15, 2029

8512717

Mar. 7, 2028

9192571

Mar. 7, 2028

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Vanda Pharmaceuticals Inc. v. Apotex Inc. et al 1:2023cv00153 1 patentANDA 217620tasimelteon	D. Del.	2023-02-10	Active	—

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

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 Acuvail (2023)

Total Spending

$174K

Total Claims

332

Beneficiaries

164

Avg Cost/Unit

$11.47

Spending Trend

$292K(2019)→$216K(2020)→$221K(2021)→$145K(2022)→$174K(2023)

YoY Change:-0.4%

5yr CAGR:+1.9%

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

6 letters from Drugs@FDA

Date	Submission	Document
May 28, 2024	SUPPL -7	View Letter (PDF)
Dec 5, 2014	SUPPL -5	View Letter (PDF)
Nov 19, 2012	SUPPL -4	View Letter (PDF)
Nov 16, 2012	SUPPL -3	View Letter (PDF)
Jul 1, 2010	SUPPL -1	View Letter (PDF)
Jul 30, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.45%

RLD

3 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jul 22, 2009

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7842714	Aug 15, 2029	—	Yes	Yes	—	—
8512717	Mar 7, 2028	—	—	Yes	—	—
9192571	Mar 7, 2028	—	—	Yes	—	—