Drybench Patent.
MACITENTAN; TADALAFIL, NDA 218490
The patents and exclusivities FDA's Orange Book lists for NDA 218490 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 5 Dec 2025 to 22 Sep 2031, each by its own rule; no one date stands for this product.
- Earliest listed date
- 5 Dec 2025US 7,094,781, substance and product patentRule R1 · Products 001, 002
Source lines
patent.txt lines 21,095, 21,101
- Latest listed date
- 22 Sep 2031PED exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 2,159, 2,163
- Latest substance patent
- 5 Jun 2026US 7,094,781 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 21,094, 21,100
- Latest listed patent
- 18 Oct 2029US 8,268,847 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 21,096, 21,102
- Latest exclusivity
- 22 Sep 2031PED exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 2,159, 2,163
Listed dates of other NDAs in the same years:20252026202720292031
4 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 218490, as listed. The sections below name products by these numbers.
Product 001 · OPSYNVI
- Dosage form; route
- TABLET;
ORAL - Strength
- 10MG;20MG
- Approval date as listed
- 22 Mar 2024
- Type as listed
- RX
- Applicant as listed
- ACTELION PHARMACEUTICALS US INC
Product 002 · OPSYNVI
- Dosage form; route
- TABLET;
ORAL - Strength
- 10MG;40MG
- Approval date as listed
- 22 Mar 2024
- 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.
6 entries from 12 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,094,781, substance and product patent
patent.txt lines 21,095, 21,101- Expiry as listed
- 5 Dec 2025
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 7,094,781 with pediatric exclusivity, as listed
patent.txt lines 21,094, 21,100- Expiry as listed
- 5 Jun 2026
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,946,015, product and use patent
patent.txt lines 21,093, 21,099- Expiry as listed
- 11 Sep 2026
- Rule
- R1
- Flags
- product · use code U-3881
- Product numbers
- 001, 002
US 10,946,015 with pediatric exclusivity, as listed
patent.txt lines 21,092, 21,098- Expiry as listed
- 11 Mar 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,268,847, product and use patent
patent.txt lines 21,097, 21,103- Expiry as listed
- 18 Apr 2029
- Rule
- R1
- Flags
- product · use code U-3882
- Product numbers
- 001, 002
US 8,268,847 with pediatric exclusivity, as listed
patent.txt lines 21,096, 21,102- Expiry as listed
- 18 Oct 2029
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 218490, 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 2,156, 2,160- Date
- 22 Mar 2027
- Rule
- R3
- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 2,158, 2,162- Date
- 22 Sep 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-475 exclusivity
exclusivity.txt lines 2,157, 2,161- Date
- 22 Mar 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 2,159, 2,163- Date
- 22 Sep 2031
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 218490
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 218490, 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 218490 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