Drybench Patent.
FIDAXOMICIN, NDA 213138
The patents and exclusivities FDA's Orange Book lists for NDA 213138 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 24 Jan 2027 to 28 Nov 2034, each by its own rule; no one date stands for this product.
- Earliest listed date
- 24 Jan 2027ODE-367 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 1,158
- Latest listed date
- 28 Nov 2034US 9,808,530 with pediatric exclusivity, as listedRule R2 · Product 001
Source lines
patent.txt line 14,700
- Latest substance patent
- 31 Jan 2028US 7,378,508 with pediatric exclusivity, as listedRule R2 · Product 001
Source lines
patent.txt line 14,692
- Latest listed patent
- 28 Nov 2034US 9,808,530 with pediatric exclusivity, as listedRule R2 · Product 001
Source lines
patent.txt line 14,700
- Latest exclusivity
- 24 Jan 2027ODE-367 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 1,158
Listed dates of other NDAs in the same years:202720282034
2 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 213138, as listed. The sections below name products by these numbers.
Product 001 · DIFICID
- Dosage form; route
- FOR SUSPENSION;
ORAL - Strength
- 40MG/ML
- Approval date as listed
- 24 Jan 2020
- Type as listed
- RX
- Applicant as listed
- CUBIST PHARMACEUTICALS LLC
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.
10 entries from 10 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,906,489, use patent
patent.txt line 14,697- Expiry as listed
- 4 Mar 2027
- Rule
- R1
- Flags
- use code U-2741
- Product numbers
- 001
US 7,378,508, substance and product patent
patent.txt line 14,693- Expiry as listed
- 31 Jul 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 7,863,249, product patent
patent.txt line 14,695- Expiry as listed
- 31 Jul 2027
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 8,859,510, use patent
patent.txt line 14,699- Expiry as listed
- 31 Jul 2027
- Rule
- R1
- Flags
- use code U-2741
- Product numbers
- 001
US 7,906,489 with pediatric exclusivity, as listed
patent.txt line 14,696- Expiry as listed
- 4 Sep 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 7,378,508 with pediatric exclusivity, as listed
patent.txt line 14,692- Expiry as listed
- 31 Jan 2028
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 7,863,249 with pediatric exclusivity, as listed
patent.txt line 14,694- Expiry as listed
- 31 Jan 2028
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 8,859,510 with pediatric exclusivity, as listed
patent.txt line 14,698- Expiry as listed
- 31 Jan 2028
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 9,808,530, product patent
patent.txt line 14,701- Expiry as listed
- 28 May 2034
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 9,808,530 with pediatric exclusivity, as listed
patent.txt line 14,700- Expiry as listed
- 28 Nov 2034
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
Listed exclusivities
Each exclusivity FDA lists for NDA 213138, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-367 exclusivity
exclusivity.txt line 1,158- Date
- 24 Jan 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 213138
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213138, each cell as listed.
Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.
No row of the Paragraph IV list captured on 17 October 2026 gives NDA 213138 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.
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