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SAPROPTERIN DIHYDROCHLORIDE, NDA 022181

The patents and exclusivities FDA's Orange Book lists for NDA 022181 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.

Open in the appSAPROPTERIN DIHYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 16 Nov 2025 to 16 May 2026, each by its own rule; no one date stands for this product.

Earliest listed date
16 Nov 2025US 7,566,462, product patentRule R1 · Product 001 · patent.txt line 1,139
Latest listed date
16 May 2026US 8,003,126 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 1,140
Latest substance patent
None listed
Latest listed patent
16 May 2026US 8,003,126 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 1,140
Latest exclusivity
None listed

Products

Each product number FDA lists under NDA 022181, as listed. The sections below name products by these numbers.

  • Product 001 · KUVAN

    Dosage form; route
    TABLET;ORAL
    Strength
    100MG
    Approval date as listed
    13 Dec 2007
    Type as listed
    RX
    Applicant as listed
    BIOMARIN PHARMACEUTICAL 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.

4 entries from 4 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,566,462, product patent

    patent.txt line 1,139
    Expiry as listed
    16 Nov 2025
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 8,003,126, unflagged patent

    patent.txt line 1,141
    Expiry as listed
    16 Nov 2025
    Rule
    R1
    Flags
    not flagged
    Product numbers
    001

  • US 7,566,462 with pediatric exclusivity, as listed

    patent.txt line 1,138
    Expiry as listed
    16 May 2026
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001

  • US 8,003,126 with pediatric exclusivity, as listed

    patent.txt line 1,140
    Expiry as listed
    16 May 2026
    Rule
    R2
    Flags
    pediatric, as listed by FDA
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 022181, 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 022181.

Paragraph IV list rows giving NDA 022181

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 022181, 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 022181

  • Sapropterin Dihydrochloride · Tablets · 100 mg

    RLD/NDA as listed: Kuvan 22181
    First PIV submission
    5 Jun 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 Nov 2019
    First applicant approval
    10 May 2019
    First marketing
    1 Oct 2020
    Last qualifying patent expiry (as listed by FDA)
    16 Nov 2025

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