open-label rifaximin — Competitive Intelligence Brief

open-label rifaximin (open-label rifaximin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Rifamycin antibiotic. Area: Gastroenterology.

phase 3 Rifamycin antibiotic RNA polymerase Gastroenterology Small molecule

Target snapshot

open-label rifaximin (open-label rifaximin) — Bausch Health Americas, Inc.. Rifaximin works by inhibiting bacterial RNA synthesis, thereby reducing bacterial load in the gut.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
open-label rifaximin TARGET	open-label rifaximin	Bausch Health Americas, Inc.	phase 3	Rifamycin antibiotic	RNA polymerase
Veklury	remdesivir	Gilead Sciences	marketed	Nucleotide analog RNA polymerase inhibitor	SARS-CoV-2 RNA polymerase	2020-01-01
RIFAMPIN	RIFAMPIN		marketed	Rifamycin Antibacterial [EPC]	DNA-dependent RNA polymerase	1971-01-01
Peg-IFN + LD RBV for 24 weeks	Peg-IFN + LD RBV for 24 weeks	National Taiwan University Hospital	marketed	Antiviral combination therapy	Interferon alpha receptor; HCV RNA-dependent RNA polymerase
Xifaxan	rifaximin	Bausch Health	marketed	Rifamycin Antibacterial [EPC]	Nuclear receptor subfamily 1 group I member 2, Bacterial DNA-directed RNA polymerase
Rifampicin (RIF)	Rifampicin (RIF)	National Institute of Allergy and Infectious Diseases (NIAID)	marketed	Rifamycin antibiotic	Bacterial RNA polymerase (RNAP)
LDV/SOF FDC	LDV/SOF FDC	HepNet Study House, German Liverfoundation	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and NS5B RNA-dependent RNA polymerase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2027-09-02 — Xifaxan · 8193196 · Compound · US
• 2029-02-26 — Xifaxan · 11564912 · Method of Use · US
• 2029-02-26 — Xifaxan · 10456384 · Method of Use · US
• 2029-02-26 — Xifaxan · 11779571 · Method of Use · US
• 2029-02-26 — Xifaxan · 10765667 · Method of Use · US
• 2029-07-18 — Xifaxan · 8309569 · Method of Use · US
• 2029-07-24 — Xifaxan · 10314828 · Method of Use · US
• 2029-07-24 — Xifaxan · 10709694 · Method of Use · US
• 2029-07-24 — Xifaxan · 10335397 · Method of Use · US
• 2029-07-24 — Xifaxan · 8829017 · Method of Use · US
• 2029-07-24 — Xifaxan · 9421195 · Method of Use · US
• 2029-07-24 — Xifaxan · 8946252 · Method of Use · US
• 2029-07-24 — Xifaxan · 7928115 · Method of Use · US
• 2029-07-24 — Xifaxan · 9629828 · Method of Use · US
• 2029-10-02 — Xifaxan · 8969398 · Method of Use · US
• 2029-10-02 — Xifaxan · 8642573 · Method of Use · US

Sponsor landscape (Rifamycin antibiotic class)

1. Institute of Tropical Medicine, Belgium · 2 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 2 drugs in this class
3. National Taiwan University Hospital · 2 drugs in this class
4. Bausch Health Americas, Inc. · 2 drugs in this class
5. South China Children's Leukemia Group · 1 drug in this class
6. Suzhou Zelgen Biopharmaceuticals Co.,Ltd · 1 drug in this class
7. TenNor Therapeutics (Suzhou) Limited · 1 drug in this class
8. The University of Texas Health Science Center at Tyler · 1 drug in this class
9. University College, London · 1 drug in this class
10. University of California, San Francisco · 1 drug in this class