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SELEXIPAG, NDA 207947

The patents and exclusivities FDA's Orange Book lists for NDA 207947 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 appSELEXIPAG in the molecule app

Listed protection

Listed dates run from 31 Oct 2026 to 1 Jun 2037, each by its own rule; no one date stands for this product.

Earliest listed date
31 Oct 2026US 7,205,302, substance and product and use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 010, 011 · patent.txt lines 7,699, 7,711, 7,723, 7,735, 7,747, 7,759, 7,771, 7,783, 7,795, 7,807
Latest listed date
1 Jun 2037US 10,828,298 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006, 007, 008, 010, 011 · patent.txt lines 7,696, 7,708, 7,720, 7,732, 7,744, 7,756, 7,768, 7,780, 7,792, 7,804
Latest substance patent
1 Feb 2031US 8,791,122 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006, 007, 008, 010, 011 · patent.txt lines 7,700, 7,712, 7,724, 7,736, 7,748, 7,760, 7,772, 7,784, 7,796, 7,808
Latest listed patent
1 Jun 2037US 10,828,298 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006, 007, 008, 010, 011 · patent.txt lines 7,696, 7,708, 7,720, 7,732, 7,744, 7,756, 7,768, 7,780, 7,792, 7,804
Latest exclusivity
23 Nov 2029PED exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006, 007, 008, 010, 011 · exclusivity.txt lines 657, 659, 661, 663, 665, 667, 669, 671, 673, 675

50 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 207947, as listed. The sections below name products by these numbers.

  • Product 001 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.2MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 002 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.4MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 003 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.6MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 004 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.8MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 005 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    1MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 006 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    1.2MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 007 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    1.4MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 008 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    1.6MG
    Approval date as listed
    21 Dec 2015
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 010 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.1MG
    Approval date as listed
    23 May 2026
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US INC
  • Product 011 · UPTRAVI

    Dosage form; route
    TABLET;ORAL
    Strength
    0.15MG
    Approval date as listed
    23 May 2026
    Type as listed
    RX
    Applicant as listed
    ACTELION PHARMACEUTICALS US 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.

12 entries from 120 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,205,302, substance and product and use patent

    patent.txt lines 7,699, 7,711, 7,723, 7,735, 7,747, 7,759, 7,771, 7,783, 7,795, 7,807
    Expiry as listed
    31 Oct 2026
    Rule
    R1
    Flags
    substance · product · use code U-1797
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 7,205,302 with pediatric exclusivity, as listed

    patent.txt lines 7,698, 7,710, 7,722, 7,734, 7,746, 7,758, 7,770, 7,782, 7,794, 7,806
    Expiry as listed
    30 Apr 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 9,173,881, use patent

    patent.txt lines 7,703, 7,715, 7,727, 7,739, 7,751, 7,763, 7,775, 7,787, 7,799, 7,811
    Expiry as listed
    12 Aug 2029
    Rule
    R1
    Flags
    use code U-1798
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 9,173,881 with pediatric exclusivity, as listed

    patent.txt lines 7,702, 7,714, 7,726, 7,738, 7,750, 7,762, 7,774, 7,786, 7,798, 7,810
    Expiry as listed
    12 Feb 2030
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 9,284,280, use patent

    patent.txt lines 7,705, 7,717, 7,729, 7,741, 7,753, 7,765, 7,777, 7,789, 7,801, 7,813
    Expiry as listed
    25 Jun 2030
    Rule
    R1
    Flags
    use code U-1831
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 8,791,122, substance and product patent

    patent.txt lines 7,701, 7,713, 7,725, 7,737, 7,749, 7,761, 7,773, 7,785, 7,797, 7,809
    Expiry as listed
    1 Aug 2030
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 9,284,280 with pediatric exclusivity, as listed

    patent.txt lines 7,704, 7,716, 7,728, 7,740, 7,752, 7,764, 7,776, 7,788, 7,800, 7,812
    Expiry as listed
    25 Dec 2030
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 8,791,122 with pediatric exclusivity, as listed

    patent.txt lines 7,700, 7,712, 7,724, 7,736, 7,748, 7,760, 7,772, 7,784, 7,796, 7,808
    Expiry as listed
    1 Feb 2031
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 10,821,108, product and use patent

    patent.txt lines 7,695, 7,707, 7,719, 7,731, 7,743, 7,755, 7,767, 7,779, 7,791, 7,803
    Expiry as listed
    1 Dec 2036
    Rule
    R1
    Flags
    product · use code U-2992
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 10,828,298, product and use patent

    patent.txt lines 7,697, 7,709, 7,721, 7,733, 7,745, 7,757, 7,769, 7,781, 7,793, 7,805
    Expiry as listed
    1 Dec 2036
    Rule
    R1
    Flags
    product · use code U-2991
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 10,821,108 with pediatric exclusivity, as listed

    patent.txt lines 7,694, 7,706, 7,718, 7,730, 7,742, 7,754, 7,766, 7,778, 7,790, 7,802
    Expiry as listed
    1 Jun 2037
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011
  • US 10,828,298 with pediatric exclusivity, as listed

    patent.txt lines 7,696, 7,708, 7,720, 7,732, 7,744, 7,756, 7,768, 7,780, 7,792, 7,804
    Expiry as listed
    1 Jun 2037
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011

Listed exclusivities

Each exclusivity FDA lists for NDA 207947, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NPP exclusivity

    exclusivity.txt lines 656, 658, 660, 662, 664, 666, 668, 670
    Date
    23 May 2029
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008
  • NS exclusivity

    exclusivity.txt lines 672, 674
    Date
    23 May 2029
    Rule
    R3
    Definition
    New strength (to be checked against FDA's list)
    Product numbers
    010, 011
  • PED exclusivity

    exclusivity.txt lines 657, 659, 661, 663, 665, 667, 669, 671, 673, 675
    Date
    23 Nov 2029
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 010, 011

Paragraph IV list rows giving NDA 207947

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 207947, 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 207947

  • Selexipag · Tablets · 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg

    RLD/NDA as listed: Uptravi 207947
    First PIV submission
    23 Dec 2019
    ANDAs
    4
    180-day status
    Eligible
    Decision posted
    10 Jan 2023
    First applicant approval
    21 Dec 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Aug 2030

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