Drybench Patent.
BEROTRALSTAT DIHYDROCHLORIDE, NDA 219776
The patents and exclusivities FDA's Orange Book lists for NDA 219776 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.
Open in the appBEROTRALSTAT DIHYDROCHLORIDE in the molecule app
Listed protection
Listed dates run from 11 Dec 2028 to 1 May 2040, each by its own rule; no one date stands for this product.
- Earliest listed date
- 11 Dec 2028NP exclusivityRule R3 · Products 001, 002, 003, 004
Source lines
exclusivity.txt lines 2,323, 2,325, 2,327, 2,329
- Latest listed date
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004
Source lines
patent.txt lines 21,910, 21,942, 21,974, 22,006
- Latest substance patent
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004
Source lines
patent.txt lines 21,910, 21,942, 21,974, 22,006
- Latest listed patent
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004
Source lines
patent.txt lines 21,910, 21,942, 21,974, 22,006
- Latest exclusivity
- 11 Jun 2029PED exclusivityRule R3 · Products 001, 002, 003, 004
Source lines
exclusivity.txt lines 2,324, 2,326, 2,328, 2,330
Listed dates of other NDAs in the same years:20282029203520392040
32 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 219776, as listed. The sections below name products by these numbers.
Product 001 · ORLADEYO
- Dosage form; route
- PELLETS;
ORAL - Strength
- EQ 72MG BASE/PACKET
- Approval date as listed
- 11 Dec 2025
- Type as listed
- RX
- Applicant as listed
- BIOCRYST PHARMACEUTICALS INC
Product 002 · ORLADEYO
- Dosage form; route
- PELLETS;
ORAL - Strength
- EQ 96MG BASE/PACKET
- Approval date as listed
- 11 Dec 2025
- Type as listed
- RX
- Applicant as listed
- BIOCRYST PHARMACEUTICALS INC
Product 003 · ORLADEYO
- Dosage form; route
- PELLETS;
ORAL - Strength
- EQ 108MG BASE/PACKET
- Approval date as listed
- 11 Dec 2025
- Type as listed
- RX
- Applicant as listed
- BIOCRYST PHARMACEUTICALS INC
Product 004 · ORLADEYO
- Dosage form; route
- PELLETS;
ORAL - Strength
- EQ 132MG BASE/PACKET
- Approval date as listed
- 11 Dec 2025
- Type as listed
- RX
- Applicant as listed
- BIOCRYST 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.
32 entries from 128 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,329,260, substance patent
patent.txt lines 21,883, 21,915, 21,947, 21,979- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002, 003, 004
US 10,689,346, use patent
patent.txt lines 21,887, 21,919, 21,951, 21,983- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-4535
- Product numbers
- 001, 002, 003, 004
US 11,230,530, use patent
patent.txt lines 21,891, 21,923, 21,955, 21,987- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-4535
- Product numbers
- 001, 002, 003, 004
US 11,708,333, use patent
patent.txt lines 21,895, 21,927, 21,959, 21,991- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-4535
- Product numbers
- 001, 002, 003, 004
US 12,116,346, substance patent
patent.txt lines 21,897, 21,929, 21,961, 21,993- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002, 003, 004
US 10,125,102, substance and use patent
patent.txt lines 21,881, 21,913, 21,945, 21,977- Expiry as listed
- 7 Apr 2035
- Rule
- R1
- Flags
- substance · use code U-4535
- Product numbers
- 001, 002, 003, 004
US 10,329,260 with pediatric exclusivity, as listed
patent.txt lines 21,882, 21,914, 21,946, 21,978- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 10,689,346 with pediatric exclusivity, as listed
patent.txt lines 21,886, 21,918, 21,950, 21,982- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 11,230,530 with pediatric exclusivity, as listed
patent.txt lines 21,890, 21,922, 21,954, 21,986- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 11,708,333 with pediatric exclusivity, as listed
patent.txt lines 21,894, 21,926, 21,958, 21,990- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,116,346 with pediatric exclusivity, as listed
patent.txt lines 21,896, 21,928, 21,960, 21,992- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 10,125,102 with pediatric exclusivity, as listed
patent.txt lines 21,880, 21,912, 21,944, 21,976- Expiry as listed
- 7 Oct 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 10,662,160, substance and use patent
patent.txt lines 21,885, 21,917, 21,949, 21,981- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · use code U-4535
- Product numbers
- 001, 002, 003, 004
US 11,117,867, product and use patent
patent.txt lines 21,889, 21,921, 21,953, 21,985- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- product · use code U-4535
- Product numbers
- 001, 002, 003, 004
US 11,618,733, use patent
patent.txt lines 21,893, 21,925, 21,957, 21,989- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- use code U-4535
- Product numbers
- 001, 002, 003, 004
US 12,344,585, use patent
patent.txt lines 21,899, 21,931, 21,963, 21,995- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- use code U-4535
- Product numbers
- 001, 002, 003, 004
US 12,545,645, substance and product patent
patent.txt lines 21,901, 21,933, 21,965, 21,997- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 12,545,646, substance and product patent
patent.txt lines 21,903, 21,935, 21,967, 21,999- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 12,545,647, substance and product patent
patent.txt lines 21,905, 21,937, 21,969, 22,001- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 12,552,750, substance and product patent
patent.txt lines 21,907, 21,939, 21,971, 22,003- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 12,590,068, substance and product patent
patent.txt lines 21,909, 21,941, 21,973, 22,005- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 12,590,069, substance and product patent
patent.txt lines 21,911, 21,943, 21,975, 22,007- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 10,662,160 with pediatric exclusivity, as listed
patent.txt lines 21,884, 21,916, 21,948, 21,980- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 11,117,867 with pediatric exclusivity, as listed
patent.txt lines 21,888, 21,920, 21,952, 21,984- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 11,618,733 with pediatric exclusivity, as listed
patent.txt lines 21,892, 21,924, 21,956, 21,988- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,344,585 with pediatric exclusivity, as listed
patent.txt lines 21,898, 21,930, 21,962, 21,994- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,545,645 with pediatric exclusivity, as listed
patent.txt lines 21,900, 21,932, 21,964, 21,996- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,545,646 with pediatric exclusivity, as listed
patent.txt lines 21,902, 21,934, 21,966, 21,998- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,545,647 with pediatric exclusivity, as listed
patent.txt lines 21,904, 21,936, 21,968, 22,000- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,552,750 with pediatric exclusivity, as listed
patent.txt lines 21,906, 21,938, 21,970, 22,002- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,590,068 with pediatric exclusivity, as listed
patent.txt lines 21,908, 21,940, 21,972, 22,004- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,590,069 with pediatric exclusivity, as listed
patent.txt lines 21,910, 21,942, 21,974, 22,006- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
Listed exclusivities
Each exclusivity FDA lists for NDA 219776, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NP exclusivity
exclusivity.txt lines 2,323, 2,325, 2,327, 2,329- Date
- 11 Dec 2028
- Rule
- R3
- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
PED exclusivity
exclusivity.txt lines 2,324, 2,326, 2,328, 2,330- Date
- 11 Jun 2029
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
Paragraph IV list rows giving NDA 219776
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 219776, 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 219776 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