Is there a generic for Ketorolac tromethamine?

Yes. The FDA Orange Book lists 55 approved generic (ANDA) applications for Ketorolac tromethamine, referencing the brand SPRIX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ketorolac tromethamine?

SPRIX (NDA 022382, COSETTE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ketorolac tromethamine?

The Orange Book lists 5 patents against Ketorolac tromethamine products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ketorolac tromethamine are approved?

Ketorolac tromethamine is approved in the following dosage forms: injectable, solution/drops, spray, metered, tablet.

FDA Orange Book · active-ingredient family

Ketorolac tromethamine

Ketorolac tromethamine: 7 brands, 55 generics; first approved Nov 30, 1989; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 55 ANDA applications approved.

Earliest patent expiry May 24, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 24, 2027

in 7 mo

Brand (NDA) products

Originator applications

SPRIXRLDRS
COSETTENDA 0223822010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15.75MG/SPRAY SPRAY, METERED NASAL Rx —
ACUVAILRLDRS
ABBVIENDA 0224272009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.45% SOLUTION/DROPS OPHTHALMIC Rx —
ACULAR LSRLD
ABBVIENDA 0215282003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% SOLUTION/DROPS OPHTHALMIC Rx —
ACULARRLDRS
ABBVIENDA 0197001992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
TORADOLRLD
ROCHE PALONDA 0196451991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
TORADOLRLD
ROCHE PALONDA 01969819892 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
ACULAR PRESERVATIVE FREE
ALLERGANNDA 0208111997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15.75MG/SPRAY	SPRAY, METERED	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.45%	SOLUTION/DROPS	OPHTHALMIC	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	SOLUTION/DROPS	OPHTHALMIC	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Generic (ANDA) products (55)

Abbreviated applications

KETOROLAC TROMETHAMINE
CAPLINANDA 2182042024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
KETOROLAC TROMETHAMINE
ASPIROANDA 21716620232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
CAPLINANDA 21778920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
BIONPHARMAANDA 2167592023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
LEADINGANDA 2157452023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
ALEMBICANDA 21445620222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
ATNAHS PHARMA USANDA 2164072022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
KETOROLAC TROMETHAMINE
ZYDUS LIFESCIENCESANDA 2170382022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
HETERO LABS LTD IIIANDA 2166512022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
SENORES PHARMSANDA 2157882022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
EUGIA PHARMAANDA 2051902020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
EUGIA PHARMAANDA 21293920202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
NEPHRONANDA 2114452020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
MICRO LABS LTD INDIAANDA 2034102019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
KETOROLAC TROMETHAMINE
EUGIA PHARMAANDA 2051912018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
CHARTWELL RXANDA 2106162018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINE
BAXTER HLTHCARE CORPANDA 20990020182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Rx AP
15MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
GLANDANDA 20421620162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
FRESENIUS KABI USAANDA 20324220152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
ONESOURCE SPECIALTYANDA 20115520142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
EPIC PHARMA LLCANDA 2033762014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.45% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
SAGENT PHARMS INCANDA 09106520132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
APOTEXANDA 0773082009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
APOTEXANDA 0761092009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
KETOROLAC TROMETHAMINE
CHARTWELL RXANDA 0784342009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
EPIC PHARMA LLCANDA 0783992009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
SANDOZANDA 0787212009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
SANDOZANDA 0765832009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
KETOROLAC TROMETHAMINE
SUN PHARMANDA 0900172009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Discontinued —
KETOROLAC TROMETHAMINE
SUN PHARMANDA 07873720082 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
LUITPOLDANDA 07814520082 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
ONESOURCE SPECIALTYANDA 07829920072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
APOTEXANDA 07794220072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
WOCKHARDT BIO AGANDA 0779432007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
APOTEX INCANDA 0772012005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
SANDOZANDA 07627120042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
GLAND PHARMA LTDANDA 07672220042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
AMPHASTAR PHARMANDA 07620920042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
HIKMAANDA 07577220042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
FRESENIUS KABI USAANDA 07578420022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
APOTEX INCANDA 0756262001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
BAXTER HLTHCARE CORPANDA 07563120012 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
15MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
APOTHECONANDA 07534820002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
HIKMAANDA 07529919992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
BEDFORDANDA 07523019992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
15MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
PLIVAANDA 0752841999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
KETOROLAC TROMETHAMINE
HIKMAANDA 07522219992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
HIKMAANDA 0752281999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
HOSPIRAANDA 07499319992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINE
WATSON LABSANDA 0749551997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
KETOROLAC TROMETHAMINE
CHARTWELL RXANDA 0747901997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
KETOROLAC TROMETHAMINE
HOSPIRAANDA 07480119972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Discontinued —
30MG/ML INJECTABLE INJECTION Discontinued —
KETOROLAC TROMETHAMINERS
HOSPIRAANDA 07480219972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG/ML INJECTABLE INJECTION Rx AP
30MG/ML INJECTABLE INJECTION Rx AP
KETOROLAC TROMETHAMINE
MYLANANDA 0747611997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
KETOROLAC TROMETHAMINERS
TEVAANDA 0747541997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Rx	AP
15MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.45%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Rx	AP
30MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/ML	INJECTABLE	INJECTION	Discontinued	—
15MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG/ML	INJECTABLE	INJECTION	Discontinued	—
30MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8008338	May 24, 2027	in 7 mo	SubstanceProductU-1181
8008338*PED	Nov 24, 2027	in 1 yr 2 mo
8512717	Mar 07, 2028	in 1 yr 5 mo	Product
9192571	Mar 07, 2028	in 1 yr 5 mo	Product
7842714	Aug 15, 2029	in 2 yr 11 mo	SubstanceProduct

Approval history

FDA approval span

First approval

Nov 30, 1989

37 yr 5 mo ago

Most recent approval

Mar 26, 2024

2 yr 7 mo ago

Approvals span 1989–2024 across 62 FDA applications.

Brand (NDA) 711%

Generic (ANDA) 5589%

Ketorolac tromethamine: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Go beyond the database.

Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.

Try Assyro Intelligence for free Book a demo