Drybench Patent.

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE, NDA 208799

The patents and exclusivities FDA's Orange Book lists for NDA 208799 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 14 Feb 2031 to 6 Jan 2041, each by its own rule; no one date stands for this product.

Earliest listed date: 14 Feb 2031US 10,195,375, product patentRule R1 · Products 001, 002, 003, 004, 005, 006
Source lines
patent.txt lines 9,520, 9,528, 9,534, 9,540, 9,554, 9,566
Latest listed date: 6 Jan 2041US 11,173,259 with pediatric exclusivity, as listedRule R2 · Products 004, 005, 006
Source lines
patent.txt lines 9,543, 9,557, 9,569
Latest substance patent: None listed
Latest listed patent: 6 Jan 2041US 11,173,259 with pediatric exclusivity, as listedRule R2 · Products 004, 005, 006
Source lines
patent.txt lines 9,543, 9,557, 9,569
Latest exclusivity: None listed

Listed dates of other NDAs in the same years:2031 2034 2035 2036 2039 2040 2041

8 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 208799, as listed. The sections below name products by these numbers.

Product 001 · AIRDUO RESPICLICK
Dosage form; route
POWDER;INHALATION
Strength
0.055MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
27 Jan 2017
Type as listed
RX
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD
Product 002 · AIRDUO RESPICLICK
Dosage form; route
POWDER;INHALATION
Strength
0.113MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
27 Jan 2017
Type as listed
RX
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD
Product 003 · AIRDUO RESPICLICK
Dosage form; route
POWDER;INHALATION
Strength
0.232MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
27 Jan 2017
Type as listed
RX
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD
Product 004 · AIRDUO DIGIHALER
Dosage form; route
POWDER;INHALATION
Strength
0.055MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
12 Jul 2019
Type as listed
DISCN
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD
Product 005 · AIRDUO DIGIHALER
Dosage form; route
POWDER;INHALATION
Strength
0.113MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
12 Jul 2019
Type as listed
DISCN
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD
Product 006 · AIRDUO DIGIHALER
Dosage form; route
POWDER;INHALATION
Strength
0.232MG/INH;EQ 0.014MG BASE/INH
Approval date as listed
12 Jul 2019
Type as listed
DISCN
Applicant as listed
TEVA PHARMACEUTICAL INDUSTRIES LTD

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.

14 entries from 58 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 10,195,375, product patent
patent.txt lines 9,520, 9,528, 9,534, 9,540, 9,554, 9,566
Expiry as listed
14 Feb 2031
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
US 10,195,375 with pediatric exclusivity, as listed
patent.txt lines 9,519, 9,527, 9,533, 9,539, 9,553, 9,565
Expiry as listed
14 Aug 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
US 9,066,957, product and use patent
patent.txt lines 9,524, 9,532, 9,538, 9,550, 9,564, 9,576
Expiry as listed
6 Oct 2034
Rule
R1
Flags
product · use code U-645
Product numbers
001, 002, 003, 004, 005, 006
US 9,415,008, product and use patent
patent.txt lines 9,526, 9,552
Expiry as listed
6 Oct 2034
Rule
R1
Flags
product · use code U-645
Product numbers
001, 004
US 9,066,957 with pediatric exclusivity, as listed
patent.txt lines 9,523, 9,531, 9,537, 9,549, 9,563, 9,575
Expiry as listed
6 Apr 2035
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
US 9,415,008 with pediatric exclusivity, as listed
patent.txt lines 9,525, 9,551
Expiry as listed
6 Apr 2035
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 004
US 10,918,816, product patent
patent.txt lines 9,542, 9,556, 9,568
Expiry as listed
14 Dec 2035
Rule
R1
Flags
product
Product numbers
004, 005, 006
US 10,918,816 with pediatric exclusivity, as listed
patent.txt lines 9,541, 9,555, 9,567
Expiry as listed
14 Jun 2036
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
004, 005, 006
US 11,969,544, product patent
patent.txt lines 9,522, 9,530, 9,536, 9,548, 9,562, 9,574
Expiry as listed
20 Aug 2039
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
US 11,344,685, product patent
patent.txt lines 9,546, 9,560, 9,572
Expiry as listed
26 Sep 2039
Rule
R1
Flags
product
Product numbers
004, 005, 006
US 11,969,544 with pediatric exclusivity, as listed
patent.txt lines 9,521, 9,529, 9,535, 9,547, 9,561, 9,573
Expiry as listed
20 Feb 2040
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
US 11,344,685 with pediatric exclusivity, as listed
patent.txt lines 9,545, 9,559, 9,571
Expiry as listed
26 Mar 2040
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
004, 005, 006
US 11,173,259, product patent
patent.txt lines 9,544, 9,558, 9,570
Expiry as listed
6 Jul 2040
Rule
R1
Flags
product
Product numbers
004, 005, 006
US 11,173,259 with pediatric exclusivity, as listed
patent.txt lines 9,543, 9,557, 9,569
Expiry as listed
6 Jan 2041
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
004, 005, 006

Listed exclusivities

Each exclusivity FDA lists for NDA 208799, 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 208799.

Paragraph IV list rows giving NDA 208799

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 208799, 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 208799 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 exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week