Is there a generic for Ciprofloxacin?

Yes. The FDA Orange Book lists 16 approved generic (ANDA) applications for Ciprofloxacin, referencing the brand OTIPRIO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ciprofloxacin?

OTIPRIO (NDA 207986, ALK ABELLO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ciprofloxacin?

The Orange Book lists 8 patents against Ciprofloxacin products, with the earliest listed expiry in 2029. 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 Ciprofloxacin are approved?

Ciprofloxacin is approved in the following dosage forms: for suspension, injectable, injectable, suspension.

FDA Orange Book · active-ingredient family

Ciprofloxacin

Ciprofloxacin is approved as 5 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OTIPRIO · NDA 207986

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension, injectable, injectable, suspension

Product	Applicant	Application	TE	Approved
OTIPRIORLD	ALK ABELLO	NDA 207986	—	Dec 10, 2015
CIPRORLD×2	BAYER HLTHCARE	NDA 020780	AB	Sep 26, 1997
CIPRORLD×3	BAYER HLTHCARE	NDA 019847	—	Dec 26, 1990
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×2	BAYER HLTHCARE	NDA 019857	—	Dec 26, 1990
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	BAYER PHARMS	NDA 019858	—	Dec 26, 1990

Generic (ANDA) products (16)

Product	Applicant	Application	TE	Approved
CIPROFLOXACIN×2	CHARTWELL	ANDA 200563	AB	Mar 05, 2014
CIPROFLOXACIN×2	HIKMA FARMACEUTICA	ANDA 076717	—	Dec 22, 2009
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	HIKMA FARMACEUTICA	ANDA 078431	AP	Nov 18, 2009
CIPROFLOXACIN×2	BAXTER HLTHCARE CORP	ANDA 078062	—	Apr 29, 2008
CIPROFLOXACIN IN DEXTROSE 5%	HIKMA FARMACEUTICA	ANDA 076757	—	Apr 21, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	BAXTER HLTHCARE	ANDA 077888	—	Mar 18, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	BAXTER HLTHCARE CORP	ANDA 078024	—	Mar 18, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	BEDFORD	ANDA 078114	—	Mar 18, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	HOSPIRA	ANDA 077753	AP	Mar 18, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	INFORLIFE	ANDA 078252	AP	Mar 18, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER×2	TEVA PHARMS	ANDA 077138	—	Mar 18, 2008
CIPROFLOXACIN×2	BEDFORD LABS	ANDA 076992	—	Aug 28, 2006
CIPROFLOXACIN	BEDFORD LABS	ANDA 076993	—	Aug 28, 2006
CIPROFLOXACIN×2	DR REDDYS	ANDA 077782	—	Aug 28, 2006
CIPROFLOXACIN×2	FRESENIUS KABI USA	ANDA 076484	—	Aug 28, 2006
CIPROFLOXACIN×2	HOSPIRA	ANDA 077245	—	Aug 28, 2006

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9603796	Apr 21, 2029	in 2 yr 11 mo	SubstanceProductU-2252
9205048	Apr 21, 2029	in 2 yr 11 mo	U-1793
11369566	Apr 21, 2029	in 2 yr 11 mo	Product
9233068	Dec 11, 2029	in 3 yr 6 mo	Product
8318817	Apr 27, 2030	in 3 yr 11 mo	U-1792
9220796	Jul 01, 2035	in 9 yr 2 mo	Product
11040004	Nov 12, 2037	in 11 yr 7 mo	U-2252
11246863	Nov 27, 2038	in 12 yr 7 mo	Product

Ciprofloxacin — frequently asked questions

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

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