Is there a generic for Rifamycin sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Rifamycin sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Rifamycin sodium?

AEMCOLO (NDA 210910, COSMO TECHNOLOGIES) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Rifamycin sodium have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Rifamycin sodium. 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 Rifamycin sodium are approved?

Rifamycin sodium is approved in the following dosage form: tablet, delayed release.

FDA Orange Book · active-ingredient family

Rifamycin sodium

Rifamycin sodium: 1 brand, 0 generics; first approved Nov 16, 2018.

Brand only2 exclusivity periodsHas discontinued products

Generic status & protection

Marketing exclusivity runs through Nov 16, 2028.

Latest exclusivity ends Nov 16, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

AEMCOLORLD
COSMO TECHNOLOGIESNDA 2109102018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 194MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 194MG BASE	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NCENew chemical entity exclusivity (5 years)
Nov 16, 2023
2 yr 9 mo ago
GAINQualified infectious disease product exclusivity (adds 5 years)
Nov 16, 2028
in 2 yr 4 mo

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Nov 16, 2018

7 yr 10 mo ago

Most recent approval

Nov 16, 2018

7 yr 10 mo ago

All 1 application were approved in 2018.

Brand (NDA) 1100%

Generic (ANDA) 00%

Rifamycin sodium: 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