Low Dose Rifaximin DER — Competitive Intelligence Brief

Low Dose Rifaximin DER (Low Dose Rifaximin DER) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antibiotic. Area: Infectious Disease.

phase 2 Antibiotic RNA polymerase Infectious Disease Small molecule

Target snapshot

Low Dose Rifaximin DER (Low Dose Rifaximin DER) — Bausch Health Americas, Inc.. Inhibits bacterial RNA synthesis

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Low Dose Rifaximin DER TARGET	Low Dose Rifaximin DER	Bausch Health Americas, Inc.	phase 2	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
D+Z	D+Z	Sequential Medicine Ltd	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Epclusa (SOF/VEL)	Epclusa (SOF/VEL)	University of California, San Francisco	marketed	Direct-acting antiviral combination (nucleotide + non-nucleoside polymerase inhibitor)	HCV NS5B 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
Grazaoprevir/Elbasavir/RBV	Grazaoprevir/Elbasavir/RBV	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Direct-acting antiviral (DAA) combination; NS3/4A protease inhibitor + NS5A inhibitor + nucleoside analog	HCV NS3/4A protease; HCV NS5A protein; viral 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 (Antibiotic class)

1. Bausch Health Americas, Inc. · 2 drugs in this class
2. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
3. BioVersys AG · 1 drug in this class
4. Bosnalijek D.D · 1 drug in this class
5. Capital Medical University · 1 drug in this class
6. Dr. Reddy's Laboratories Limited · 1 drug in this class
7. Incheon St.Mary's Hospital · 1 drug in this class
8. Jomaa Pharma GmbH · 1 drug in this class
9. King Abdulaziz University · 1 drug in this class
10. Menzies School of Health Research · 1 drug in this class