Drybench Patent.
RIFAXIMIN, NDA 021361
The patents and exclusivities FDA's Orange Book lists for NDA 021361 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 27 Feb 2026 to 2 Oct 2029, each by its own rule; no one date stands for this product.
- Earliest listed date
- 27 Feb 2026US 10,703,763, use patentRule R1 · Product 001 · patent.txt line 559
- Latest listed date
- 2 Oct 2029US 8,969,398, use patentRule R1 · Product 002 · patent.txt line 588
- Latest substance patent
- 2 Sep 2027US 8,193,196, substance and product and use patentRule R1 · Product 002 · patent.txt line 578
- Latest listed patent
- 2 Oct 2029US 8,969,398, use patentRule R1 · Product 002 · patent.txt line 588
- Latest exclusivity
- None listed
2 patents with a delist request, kept in the table · 28 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 021361, as listed. The sections below name products by these numbers.
Product 001 · XIFAXAN
- Dosage form; route
- TABLET;ORAL
- Strength
- 200MG
- Approval date as listed
- 25 May 2004
- Type as listed
- RX
- Applicant as listed
- SALIX PHARMACEUTICALS INC
Product 002 · XIFAXAN
- Dosage form; route
- TABLET;ORAL
- Strength
- 550MG
- Approval date as listed
- 24 Mar 2010
- Type as listed
- RX
- Applicant as listed
- SALIX PHARMACEUTICALS INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
31 entries from 33 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,703,763, use patent
patent.txt line 559- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- use code U-2848
- Product numbers
- 001
US 10,703,763, use patent
patent.txt line 569- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- use code U-1708
- Product numbers
- 002
US 10,703,763, use patent
patent.txt line 570- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- use code U-2847
- Product numbers
- 002
US 8,518,949, product patent
patent.txt lines 562, 581- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 8,741,904, substance and product and use patent
patent.txt line 563- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- substance · product · use code U-2848
- Product numbers
- 001
US 8,741,904, substance and product and use patent
patent.txt line 583- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- substance · product · use code U-1707
- Product numbers
- 002
US 8,741,904, substance and product and use patent
patent.txt line 584- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- substance · product · use code U-1708
- Product numbers
- 002
US 8,741,904, substance and product and use patent
patent.txt line 585- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- substance · product · use code U-2847
- Product numbers
- 002
US 9,271,968, product patent
patent.txt lines 564, 589- Expiry as listed
- 27 Feb 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 8,193,196, substance and product patent
patent.txt line 561- Expiry as listed
- 2 Sep 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 8,193,196, substance and product and use patent
patent.txt line 577- Expiry as listed
- 2 Sep 2027
- Rule
- R1
- Flags
- substance · product · use code U-1707
- Product numbers
- 002
US 8,193,196, substance and product and use patent
patent.txt line 578- Expiry as listed
- 2 Sep 2027
- Rule
- R1
- Flags
- substance · product · use code U-1708
- Product numbers
- 002
US 10,456,384, use patent
patent.txt line 567- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-2643
- Product numbers
- 002
US 10,456,384, use patent
patent.txt line 568- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-2644
- Product numbers
- 002
US 10,765,667, use patent
patent.txt line 572- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-2643
- Product numbers
- 002
US 10,765,667, use patent
patent.txt line 573- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-2644
- Product numbers
- 002
US 11,564,912, use patent
patent.txt line 574- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-3511
- Product numbers
- 002
US 11,564,912, use patent
patent.txt line 575- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-3512
- Product numbers
- 002
US 11,779,571, use patent
patent.txt line 576- Expiry as listed
- 26 Feb 2029
- Rule
- R1
- Flags
- use code U-3706
- Product numbers
- 002
US 8,309,569, use patent
patent.txt line 579- Expiry as listed
- 18 Jul 2029
- Rule
- R1
- Flags
- use code U-1707 · delist requested
- Product numbers
- 002
US 8,309,569, use patent
patent.txt line 580- Expiry as listed
- 18 Jul 2029
- Rule
- R1
- Flags
- use code U-1708 · delist requested
- Product numbers
- 002
US 10,314,828, use patent
patent.txt line 565- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1481
- Product numbers
- 002
US 10,335,397, use patent
patent.txt line 566- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-2579
- Product numbers
- 002
US 10,709,694, use patent
patent.txt line 571- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-2579
- Product numbers
- 002
US 7,928,115, use patent
patent.txt line 560- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1121
- Product numbers
- 001
US 8,829,017, use patent
patent.txt line 586- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1562
- Product numbers
- 002
US 8,946,252, use patent
patent.txt line 587- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1481
- Product numbers
- 002
US 9,421,195, use patent
patent.txt line 590- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1481
- Product numbers
- 002
US 9,629,828, use patent
patent.txt line 591- Expiry as listed
- 24 Jul 2029
- Rule
- R1
- Flags
- use code U-1994
- Product numbers
- 002
US 8,642,573, use patent
patent.txt line 582- Expiry as listed
- 2 Oct 2029
- Rule
- R1
- Flags
- use code U-1481
- Product numbers
- 002
US 8,969,398, use patent
patent.txt line 588- Expiry as listed
- 2 Oct 2029
- Rule
- R1
- Flags
- use code U-1481
- Product numbers
- 002
Listed exclusivities
Each exclusivity FDA lists for NDA 021361, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 021361.
Paragraph IV list rows giving NDA 021361
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021361, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 021361
Rifaximin · Tablets · 200 mg
RLD/NDA as listed: Xifaxan 21361- First PIV submission
- 28 Jan 2019
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Jul 2029
Rifaximin · Tablets · 550 mg
RLD/NDA as listed: Xifaxan 21361- First PIV submission
- 18 Dec 2015
- ANDAs
- 1
- 180-day status
- Eligible Non-Forfeiture Non-Forfeiture
- Decision posted
- 3/19/2026 2/17/2025 8/24/2021
- First applicant approval
- 19 Mar 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Oct 2029
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week