Is there a generic for Ceftaroline fosamil?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ceftaroline fosamil, referencing the brand TEFLARO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ceftaroline fosamil?

TEFLARO (NDA 200327, ABBVIE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ceftaroline fosamil?

The Orange Book lists 2 patents against Ceftaroline fosamil products, with the earliest listed expiry in 2030. 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 Ceftaroline fosamil are approved?

Ceftaroline fosamil is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Ceftaroline fosamil

Ceftaroline fosamil: 1 brand, 1 generic; first approved Oct 29, 2010; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Sep 21, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 21, 2030

in 4 yr 2 mo

Brand (NDA) products

Originator applications

TEFLARORLDRS
ABBVIENDA 20032720102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG/VIAL POWDER INTRAVENOUS Rx AP
600MG/VIAL POWDER INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
600MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Generic (ANDA) products (1)

Abbreviated applications

CEFTAROLINE FOSAMIL
APOTEXANDA 20807520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
400MG/VIAL POWDER INTRAVENOUS Rx AP
600MG/VIAL POWDER INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
400MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
600MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

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
9629861	Sep 21, 2030	in 4 yr 2 mo	Product
8247400	Feb 10, 2031	in 4 yr 6 mo	ProductU-282

Approval history

FDA approval span

First approval

Oct 29, 2010

16 yr 1 mo ago

Most recent approval

Sep 21, 2021

5 yr ago

Approvals span 2010–2021 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Ceftaroline fosamil: 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.

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