Drybench Patent.
METHOTREXATE, NDA 204824
The patents and exclusivities FDA's Orange Book lists for NDA 204824 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 2026 to 27 May 2031, each by its own rule; no one date stands for this product.
- Earliest listed date
- 24 Jan 2026US 11,446,441, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008
Source lines
patent.txt lines 5,062, 5,077, 5,092, 5,107, 5,122, 5,137, 5,152, 5,167
- Latest listed date
- 27 May 2031US 8,814,834, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008
Source lines
patent.txt lines 5,070, 5,085, 5,100, 5,115, 5,130, 5,145, 5,160, 5,175
- Latest substance patent
- None listed
- Latest listed patent
- 27 May 2031US 8,814,834, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008
Source lines
patent.txt lines 5,070, 5,085, 5,100, 5,115, 5,130, 5,145, 5,160, 5,175
- Latest exclusivity
- None listed
Listed dates of other NDAs in the same years:2026202920302031
32 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 204824, as listed. The sections below name products by these numbers.
Product 001 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 10MG/0.4ML (10MG/0.4ML)
- Approval date as listed
- 11 Oct 2013
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 002 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 15MG/0.4ML (15MG/0.4ML)
- Approval date as listed
- 11 Oct 2013
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 003 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 20MG/0.4ML (20MG/0.4ML)
- Approval date as listed
- 11 Oct 2013
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 004 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 25MG/0.4ML (25MG/0.4ML)
- Approval date as listed
- 11 Oct 2013
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 005 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 7.5MG/0.4ML (7.5MG/0.4ML)
- Approval date as listed
- 7 Nov 2014
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 006 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 12.5MG/0.4ML (12.5MG/0.4ML)
- Approval date as listed
- 24 Mar 2016
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 007 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 17.5MG/0.4ML (17.5MG/0.4ML)
- Approval date as listed
- 24 Mar 2016
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 008 · OTREXUP
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 22.5MG/0.4ML (22.5MG/0.4ML)
- Approval date as listed
- 24 Mar 2016
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 009 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 10MG/0.4ML (10MG/0.4ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 010 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 15MG/0.6ML (15MG/0.6ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 011 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 17.5MG/0.7ML (17.5MG/0.7ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 012 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 20MG/0.8ML (20MG/0.8ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 013 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 22.5MG/0.9ML (22.5MG/0.9ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE PHARMACEUTICALS INC
Product 014 · OTREXUP PFS
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- 25MG/ML (25MG/ML)
- Approval date as listed
- 31 May 2017
- Type as listed
- DISCN
- Applicant as listed
- COSETTE 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.
15 entries from 120 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 11,446,441, product patent
patent.txt lines 5,062, 5,077, 5,092, 5,107, 5,122, 5,137, 5,152, 5,167- Expiry as listed
- 24 Jan 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,562,564, product patent
patent.txt lines 5,068, 5,083, 5,098, 5,113, 5,128, 5,143, 5,158, 5,173- Expiry as listed
- 24 Jan 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 9,533,102, product patent
patent.txt lines 5,073, 5,088, 5,103, 5,118, 5,133, 5,148, 5,163, 5,178- Expiry as listed
- 24 Jan 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 9,629,959, product patent
patent.txt lines 5,074, 5,089, 5,104, 5,119, 5,134, 5,149, 5,164, 5,179- Expiry as listed
- 24 Jan 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,021,335, product patent
patent.txt lines 5,066, 5,081, 5,096, 5,111, 5,126, 5,141, 5,156, 5,171- Expiry as listed
- 4 Oct 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 10,709,844, product patent
patent.txt lines 5,061, 5,076, 5,091, 5,106, 5,121, 5,136, 5,151, 5,166- Expiry as listed
- 10 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 11,684,723, product patent
patent.txt lines 5,064, 5,079, 5,094, 5,109, 5,124, 5,139, 5,154, 5,169- Expiry as listed
- 10 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 9,867,949, product patent
patent.txt lines 5,075, 5,090, 5,105, 5,120, 5,135, 5,150, 5,165, 5,180- Expiry as listed
- 10 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 11,497,753, product patent
patent.txt lines 5,063, 5,078, 5,093, 5,108, 5,123, 5,138, 5,153, 5,168- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 12,357,642, product patent
patent.txt lines 5,065, 5,080, 5,095, 5,110, 5,125, 5,140, 5,155, 5,170- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,480,631, product and use patent
patent.txt lines 5,067, 5,082, 5,097, 5,112, 5,127, 5,142, 5,157, 5,172- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product · use code U-1442
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,579,865, product and use patent
patent.txt lines 5,069, 5,084, 5,099, 5,114, 5,129, 5,144, 5,159, 5,174- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product · use code U-1442
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,945,063, product and use patent
patent.txt lines 5,071, 5,086, 5,101, 5,116, 5,131, 5,146, 5,161, 5,176- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product · use code U-1442
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 9,421,333, product and use patent
patent.txt lines 5,072, 5,087, 5,102, 5,117, 5,132, 5,147, 5,162, 5,177- Expiry as listed
- 19 Mar 2030
- Rule
- R1
- Flags
- product · use code U-1442
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
US 8,814,834, product patent
patent.txt lines 5,070, 5,085, 5,100, 5,115, 5,130, 5,145, 5,160, 5,175- Expiry as listed
- 27 May 2031
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
Listed exclusivities
Each exclusivity FDA lists for NDA 204824, 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 204824.
Paragraph IV list rows giving NDA 204824
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 204824, 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 204824 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