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SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR, NDA 209195

The patents and exclusivities FDA's Orange Book lists for NDA 209195 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.

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Listed protection

Listed dates run from 21 Mar 2028 to 1 Dec 2037, each by its own rule; no one date stands for this product.

Earliest listed date
21 Mar 2028US 8,334,270, substance and product and use patentRule R1 · Product 001
Source lines

patent.txt line 9,823

Latest listed date
1 Dec 2037US 11,338,007 with pediatric exclusivity, as listedRule R2 · Product 001
Source lines

patent.txt line 9,816

Latest substance patent
17 Jul 2034US 9,296,782, substance and product patentRule R1 · Product 001
Source lines

patent.txt line 9,857

Latest listed patent
1 Dec 2037US 11,338,007 with pediatric exclusivity, as listedRule R2 · Product 001
Source lines

patent.txt line 9,816

Latest exclusivity
None listed

Listed dates of other NDAs in the same years:20282029203020312032203320342037

30 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 209195, as listed. The sections below name products by these numbers.

  • Product 001 · VOSEVI

    Dosage form; route
    TABLET;ORAL
    Strength
    400MG;100MG;100MG
    Approval date as listed
    18 Jul 2017
    Type as listed
    RX
    Applicant as listed
    GILEAD SCIENCES 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.

47 entries from 47 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,334,270, substance and product and use patent

    patent.txt line 9,823
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,334,270, substance and product and use patent

    patent.txt line 9,824
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,580,765, substance and product and use patent

    patent.txt line 9,829
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,580,765, substance and product and use patent

    patent.txt line 9,830
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,735,372, substance and product and use patent

    patent.txt line 9,838
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,735,372, substance and product and use patent

    patent.txt line 9,839
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,957,046, use patent

    patent.txt line 9,849
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    use code U-2039
    Product numbers
    001
  • US 8,957,046, use patent

    patent.txt line 9,850
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    use code U-2040
    Product numbers
    001
  • US 9,085,573, substance and product and use patent

    patent.txt line 9,852
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 9,085,573, substance and product and use patent

    patent.txt line 9,853
    Expiry as listed
    21 Mar 2028
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,334,270 with pediatric exclusivity, as listed

    patent.txt line 9,822
    Expiry as listed
    21 Sep 2028
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,580,765 with pediatric exclusivity, as listed

    patent.txt line 9,828
    Expiry as listed
    21 Sep 2028
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,735,372 with pediatric exclusivity, as listed

    patent.txt line 9,837
    Expiry as listed
    21 Sep 2028
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 9,085,573 with pediatric exclusivity, as listed

    patent.txt line 9,851
    Expiry as listed
    21 Sep 2028
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 7,964,580, substance and product and use patent

    patent.txt line 9,820
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 7,964,580, substance and product and use patent

    patent.txt line 9,821
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,633,309, substance and product and use patent

    patent.txt line 9,835
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,633,309, substance and product and use patent

    patent.txt line 9,836
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,889,159, substance and product and use patent

    patent.txt line 9,841
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,889,159, substance and product and use patent

    patent.txt line 9,842
    Expiry as listed
    26 Mar 2029
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 7,964,580 with pediatric exclusivity, as listed

    patent.txt line 9,819
    Expiry as listed
    26 Sep 2029
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,633,309 with pediatric exclusivity, as listed

    patent.txt line 9,834
    Expiry as listed
    26 Sep 2029
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,889,159 with pediatric exclusivity, as listed

    patent.txt line 9,840
    Expiry as listed
    26 Sep 2029
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 9,284,342, substance and product and use patent

    patent.txt line 9,855
    Expiry as listed
    13 Sep 2030
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 9,284,342, substance and product and use patent

    patent.txt line 9,856
    Expiry as listed
    13 Sep 2030
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,618,076, substance and product and use patent

    patent.txt line 9,832
    Expiry as listed
    11 Dec 2030
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,618,076, substance and product and use patent

    patent.txt line 9,833
    Expiry as listed
    11 Dec 2030
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 9,284,342 with pediatric exclusivity, as listed

    patent.txt line 9,854
    Expiry as listed
    13 Mar 2031
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,618,076 with pediatric exclusivity, as listed

    patent.txt line 9,831
    Expiry as listed
    11 Jun 2031
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,575,135, substance and product and use patent

    patent.txt line 9,826
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,575,135, substance and product and use patent

    patent.txt line 9,827
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,921,341, substance and product and use patent

    patent.txt line 9,844
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,921,341, substance and product and use patent

    patent.txt line 9,845
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 8,940,718, substance and product and use patent

    patent.txt line 9,847
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2039
    Product numbers
    001
  • US 8,940,718, substance and product and use patent

    patent.txt line 9,848
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product · use code U-2040
    Product numbers
    001
  • US 9,868,745, substance and product patent

    patent.txt line 9,858
    Expiry as listed
    16 Nov 2032
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 8,575,135 with pediatric exclusivity, as listed

    patent.txt line 9,825
    Expiry as listed
    16 May 2033
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,921,341 with pediatric exclusivity, as listed

    patent.txt line 9,843
    Expiry as listed
    16 May 2033
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 8,940,718 with pediatric exclusivity, as listed

    patent.txt line 9,846
    Expiry as listed
    16 May 2033
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 11,116,783, product and use patent

    patent.txt line 9,814
    Expiry as listed
    30 Jan 2034
    Rule
    R1
    Flags
    product · use code U-2039
    Product numbers
    001
  • US 11,116,783, product and use patent

    patent.txt line 9,815
    Expiry as listed
    30 Jan 2034
    Rule
    R1
    Flags
    product · use code U-2040
    Product numbers
    001
  • US 9,296,782, substance and product patent

    patent.txt line 9,857
    Expiry as listed
    17 Jul 2034
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 11,116,783 with pediatric exclusivity, as listed

    patent.txt line 9,813
    Expiry as listed
    30 Jul 2034
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • US 10,912,814, product patent

    patent.txt line 9,812
    Expiry as listed
    1 Jun 2037
    Rule
    R1
    Flags
    product
    Product numbers
    001
  • US 11,338,007, product and use patent

    patent.txt line 9,817
    Expiry as listed
    1 Jun 2037
    Rule
    R1
    Flags
    product · use code U-2039
    Product numbers
    001
  • US 11,338,007, product and use patent

    patent.txt line 9,818
    Expiry as listed
    1 Jun 2037
    Rule
    R1
    Flags
    product · use code U-2040
    Product numbers
    001
  • US 11,338,007 with pediatric exclusivity, as listed

    patent.txt line 9,816
    Expiry as listed
    1 Dec 2037
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 209195, 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 209195.

Paragraph IV list rows giving NDA 209195

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 209195, 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 209195 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