Drybench Patent.
MITAPIVAT SULFATE, NDA 216196
The patents and exclusivities FDA's Orange Book lists for NDA 216196 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 17 Feb 2027 to 31 Jul 2041, each by its own rule; no one date stands for this product.
- Earliest listed date
- 17 Feb 2027NCE exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 1,736, 1,738, 1,740, 1,742
- Latest listed date
- 31 Jul 2041US 11,878,049, use patentRule R1 · Product 004 · patent.txt line 18,461
- Latest substance patent
- 21 Nov 2038US 11,254,652, substance and product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 18,434, 18,443, 18,452, 18,460
- Latest listed patent
- 31 Jul 2041US 11,878,049, use patentRule R1 · Product 004 · patent.txt line 18,461
- Latest exclusivity
- 23 Dec 2032ODE-522 exclusivityRule R3 · Product 004 · exclusivity.txt line 1,744
25 use-code patents, blocking the coded use only
This page shows only the dates FDA lists. The app also shows NCE-1, the one date it computes, with its qualifications. Open in the app
Products
Each product number FDA lists under NDA 216196, as listed. The sections below name products by these numbers.
Product 001 · PYRUKYND
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 5MG BASE
- Approval date as listed
- 17 Feb 2022
- Type as listed
- RX
- Applicant as listed
- AGIOS PHARMACEUTICALS INC
Product 002 · PYRUKYND
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 20MG BASE
- Approval date as listed
- 17 Feb 2022
- Type as listed
- RX
- Applicant as listed
- AGIOS PHARMACEUTICALS INC
Product 003 · PYRUKYND
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 50MG BASE
- Approval date as listed
- 17 Feb 2022
- Type as listed
- RX
- Applicant as listed
- AGIOS PHARMACEUTICALS INC
Product 004 · AQVESME
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 100MG BASE
- Approval date as listed
- 23 Dec 2025
- Type as listed
- RX
- Applicant as listed
- AGIOS 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.
13 entries from 33 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,632,114, use patent
patent.txt lines 18,432, 18,441, 18,450- Expiry as listed
- 3 May 2032
- Rule
- R1
- Flags
- use code U-3320
- Product numbers
- 001, 002, 003
US 10,632,114, use patent
patent.txt line 18,459- Expiry as listed
- 3 May 2032
- Rule
- R1
- Flags
- use code U-4391
- Product numbers
- 004
US 9,682,080, use patent
patent.txt lines 18,438, 18,447, 18,456- Expiry as listed
- 3 May 2032
- Rule
- R1
- Flags
- use code U-3319
- Product numbers
- 001, 002, 003
US 9,682,080, use patent
patent.txt line 18,463- Expiry as listed
- 3 May 2032
- Rule
- R1
- Flags
- use code U-4392
- Product numbers
- 004
US 9,980,961, use patent
patent.txt lines 18,439, 18,448, 18,457- Expiry as listed
- 3 May 2032
- Rule
- R1
- Flags
- use code U-3319
- Product numbers
- 001, 002, 003
US 9,193,701, use patent
patent.txt lines 18,437, 18,446, 18,455- Expiry as listed
- 26 Oct 2032
- Rule
- R1
- Flags
- use code U-3319
- Product numbers
- 001, 002, 003
US 9,193,701, use patent
patent.txt line 18,462- Expiry as listed
- 26 Oct 2032
- Rule
- R1
- Flags
- use code U-4393
- Product numbers
- 004
US 11,793,806, use patent
patent.txt lines 18,435, 18,444, 18,453- Expiry as listed
- 12 Apr 2033
- Rule
- R1
- Flags
- use code U-3320
- Product numbers
- 001, 002, 003
US RE49582, substance and product patent
patent.txt lines 18,440, 18,449, 18,458, 18,464- Expiry as listed
- 11 Apr 2035
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 11,234,976, use patent
patent.txt lines 18,433, 18,442, 18,451- Expiry as listed
- 11 Oct 2038
- Rule
- R1
- Flags
- use code U-3321
- Product numbers
- 001, 002, 003
US 11,254,652, substance and product patent
patent.txt lines 18,434, 18,443, 18,452, 18,460- Expiry as listed
- 21 Nov 2038
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 11,878,049, use patent
patent.txt lines 18,436, 18,445, 18,454- Expiry as listed
- 31 Jul 2041
- Rule
- R1
- Flags
- use code U-3782
- Product numbers
- 001, 002, 003
US 11,878,049, use patent
patent.txt line 18,461- Expiry as listed
- 31 Jul 2041
- Rule
- R1
- Flags
- use code U-4390
- Product numbers
- 004
Listed exclusivities
Each exclusivity FDA lists for NDA 216196, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NCE exclusivity
exclusivity.txt lines 1,736, 1,738, 1,740, 1,742- Date
- 17 Feb 2027
- Rule
- R3
- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
NP exclusivity
exclusivity.txt line 1,743- Date
- 23 Dec 2028
- Rule
- R3
- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 004
ODE-392 exclusivity
exclusivity.txt lines 1,737, 1,739, 1,741- Date
- 17 Feb 2029
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
ODE-522 exclusivity
exclusivity.txt line 1,744- Date
- 23 Dec 2032
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 004
Paragraph IV list rows giving NDA 216196
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 216196, 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 216196
Mitapivat · Tablets · 5 mg, 20 mg and 50 mg
RLD/NDA as listed: Pyrukynd 216196- First PIV submission
- 17 Feb 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Jul 2041
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