Drybench Patent.
LEDIPASVIR; SOFOSBUVIR, NDA 212477
The patents and exclusivities FDA's Orange Book lists for NDA 212477 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 28 Aug 2026 to 14 Mar 2033, each by its own rule; no one date stands for this product.
- Earliest listed date
- 28 Aug 2026ODE-262 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,074, 1,077
- Latest listed date
- 14 Mar 2033US 9,393,256 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 14,011, 14,042
- Latest substance patent
- 11 Jun 2031US 8,618,076 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 13,995, 14,026
- Latest listed patent
- 14 Mar 2033US 9,393,256 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 14,011, 14,042
- Latest exclusivity
- 28 Aug 2026ODE-264 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,076, 1,079
Listed dates of other NDAs in the same years:2026202820292030203120322033
28 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 212477, as listed. The sections below name products by these numbers.
Product 001 · HARVONI
- Dosage form; route
- PELLETS;
ORAL - Strength
- 33.75MG/PACKET;150MG/PACKET
- Approval date as listed
- 28 Aug 2019
- Type as listed
- RX
- Applicant as listed
- GILEAD SCIENCES INC
Product 002 · HARVONI
- Dosage form; route
- PELLETS;
ORAL - Strength
- 45MG/PACKET;200MG/PACKET
- Approval date as listed
- 28 Aug 2019
- 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.
31 entries from 62 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 lines 13,992, 14,023- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,580,765, substance and product and use patent
patent.txt lines 13,994, 14,025- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,735,372, use patent
patent.txt lines 14,000, 14,031- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- use code U-1470
- Product numbers
- 001, 002
US 9,085,573, substance and product and use patent
patent.txt lines 14,008, 14,039- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 13,991, 14,022- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 13,993, 14,024- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 13,999, 14,030- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 14,007, 14,038- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 7,964,580, substance and product and use patent
patent.txt lines 13,986, 14,017- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,633,309, substance and product and use patent
patent.txt lines 13,998, 14,029- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,889,159, product and use patent
patent.txt lines 14,006, 14,037- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- product · use code U-1470
- Product numbers
- 001, 002
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 13,985, 14,016- Expiry as listed
- 26 Sep 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 13,997, 14,028- Expiry as listed
- 26 Sep 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 14,005, 14,036- Expiry as listed
- 26 Sep 2029
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,088,368, substance and product patent
patent.txt lines 13,988, 14,019- Expiry as listed
- 12 May 2030
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,273,341, use patent
patent.txt lines 13,990, 14,021- Expiry as listed
- 12 May 2030
- Rule
- R1
- Flags
- use code U-1470
- Product numbers
- 001, 002
US 8,822,430, substance and product and use patent
patent.txt lines 14,002, 14,033- Expiry as listed
- 12 May 2030
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,841,278, product and use patent
patent.txt lines 14,004, 14,035- Expiry as listed
- 12 May 2030
- Rule
- R1
- Flags
- product · use code U-1470
- Product numbers
- 001, 002
US 9,511,056, use patent
patent.txt lines 14,014, 14,045- Expiry as listed
- 12 May 2030
- Rule
- R1
- Flags
- use code U-1470
- Product numbers
- 001, 002
US 9,284,342, substance and product and use patent
patent.txt lines 14,010, 14,041- Expiry as listed
- 13 Sep 2030
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 8,088,368 with pediatric exclusivity, as listed
patent.txt lines 13,987, 14,018- Expiry as listed
- 12 Nov 2030
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,273,341 with pediatric exclusivity, as listed
patent.txt lines 13,989, 14,020- Expiry as listed
- 12 Nov 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,822,430 with pediatric exclusivity, as listed
patent.txt lines 14,001, 14,032- Expiry as listed
- 12 Nov 2030
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,841,278 with pediatric exclusivity, as listed
patent.txt lines 14,003, 14,034- Expiry as listed
- 12 Nov 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,511,056 with pediatric exclusivity, as listed
patent.txt lines 14,013, 14,044- Expiry as listed
- 12 Nov 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,618,076, substance and product and use patent
patent.txt lines 13,996, 14,027- Expiry as listed
- 11 Dec 2030
- Rule
- R1
- Flags
- substance · product · use code U-1470
- Product numbers
- 001, 002
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 14,009, 14,040- Expiry as listed
- 13 Mar 2031
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 13,995, 14,026- Expiry as listed
- 11 Jun 2031
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,456,414, product patent
patent.txt lines 13,984, 14,015- Expiry as listed
- 14 Sep 2032
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 9,393,256, use patent
patent.txt lines 14,012, 14,043- Expiry as listed
- 14 Sep 2032
- Rule
- R1
- Flags
- use code U-1470
- Product numbers
- 001, 002
US 9,393,256 with pediatric exclusivity, as listed
patent.txt lines 14,011, 14,042- Expiry as listed
- 14 Mar 2033
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 212477, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-262 exclusivity
exclusivity.txt lines 1,074, 1,077- Date
- 28 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-263 exclusivity
exclusivity.txt lines 1,075, 1,078- Date
- 28 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-264 exclusivity
exclusivity.txt lines 1,076, 1,079- Date
- 28 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 212477
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212477, 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 212477 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