Is there a generic for Fidaxomicin?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Fidaxomicin, referencing the brand DIFICID. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fidaxomicin?

DIFICID (NDA 213138, CUBIST PHARMS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Fidaxomicin?

The Orange Book lists 10 patents against Fidaxomicin 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.

Does Fidaxomicin have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Fidaxomicin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Fidaxomicin are approved?

Fidaxomicin is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Fidaxomicin

Fidaxomicin: 2 brands, 3 generics; first approved May 27, 2011; generic available.

Generic available2 exclusivity periods

Generic status & protection

Generic available — 3 ANDA applications approved.

Earliest patent expiry Mar 04, 2027Latest exclusivity ends Jan 24, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 04, 2027

in 8 mo

Originator applications

Brand (NDA) products

DIFICIDRLDRS

CUBIST PHARMS LLCNDA 2131382020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/ML	FOR SUSPENSION	ORAL	Rx	—

DIFICIDRLDRS

CUBIST PHARMS LLCNDA 2016992011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (3)

FIDAXOMICIN

APOTEXANDA 2195592026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

FIDAXOMICIN

TORRENTANDA 2203742026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

FIDAXOMICIN

ACTAVIS LABS FLANDA 2084432024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

ODE-367Orphan-drug exclusivity (7 years)
Jan 24, 2027
in 7 mo
ODE-367Orphan-drug exclusivity (7 years)
Jan 24, 2027
in 7 mo

Orange Book patent file

Listed patents

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7906489	Mar 04, 2027	in 8 mo	U-2741
8859510	Jul 31, 2027	in 1 yr 1 mo	U-2741
7378508	Jul 31, 2027	in 1 yr 1 mo	SubstanceProduct
7863249	Jul 31, 2027	in 1 yr 1 mo	Product
7906489*PED	Sep 04, 2027	in 1 yr 2 mo
7378508*PED	Jan 31, 2028	in 1 yr 7 mo
7863249*PED	Jan 31, 2028	in 1 yr 7 mo
8859510*PED	Jan 31, 2028	in 1 yr 7 mo
9808530	May 28, 2034	in 8 yr	Product
9808530*PED	Nov 28, 2034	in 8 yr 6 mo

FDA approval span

Approval history

First approval

May 27, 2011

15 yr 4 mo ago

Most recent approval

Feb 02, 2026

5 mo ago

Approvals span 2011–2026 across 5 FDA applications.

Brand (NDA) 240%

Generic (ANDA) 360%

Fidaxomicin — 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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo