SPRIX Drug Patent Profile

Which patents cover Sprix, and what generic alternatives are available?

Sprix is a drug marketed by Zyla and is included in one NDA.

The generic ingredient in SPRIX is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sprix

A generic version of SPRIX was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for SPRIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	97
Patent Applications:	3,821
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SPRIX
What excipients (inactive ingredients) are in SPRIX?	SPRIX excipients list
DailyMed Link:	SPRIX at DailyMed

See drug prices for SPRIX

Pharmacology for SPRIX

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SPRIX

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for SPRIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRIX	Nasal Spray	ketorolac tromethamine	15.75 mg/spray	022382	1	2012-03-12

US Patents and Regulatory Information for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010		RX	Yes	Yes

Expired US Patents for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010

International Patents for SPRIX

See the table below for patents covering SPRIX around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H05194215	THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID
European Patent Office	0524587	Compositions thérapeutiques pour l'administration intranasale contenant ketorolac R. (Therapeutic compositions for intranasal administration which include ketorolac TM.)
Denmark	0524587
Italy	MI912024

Supplementary Protection Certificates for SPRIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728