Drybench Patent.
MACITENTAN, NDA 204410
The patents and exclusivities FDA's Orange Book lists for NDA 204410 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. 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 18 Oct 2029, 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 · Product 001 · patent.txt line 4,669
- Latest listed date
- 18 Oct 2029US 8,268,847 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 4,670
- Latest substance patent
- 5 Jun 2026US 7,094,781 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 4,668
- Latest listed patent
- 18 Oct 2029US 8,268,847 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 4,670
- Latest exclusivity
- 28 Aug 2028PED exclusivityRule R3 · Product 001 · exclusivity.txt line 427
4 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 204410, as listed. The sections below name products by these numbers.
Product 001 · OPSUMIT
- Dosage form; route
- TABLET;ORAL
- Strength
- 10MG
- Approval date as listed
- 18 Oct 2013
- 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.
10 entries from 10 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 line 4,669- Expiry as listed
- 5 Dec 2025
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 7,094,781 with pediatric exclusivity, as listed
patent.txt line 4,668- Expiry as listed
- 5 Jun 2026
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 10,946,015, product and use patent
patent.txt line 4,667- Expiry as listed
- 11 Sep 2026
- Rule
- R1
- Flags
- product · use code U-1445
- Product numbers
- 001
US 10,946,015 with pediatric exclusivity, as listed
patent.txt line 4,666- Expiry as listed
- 11 Mar 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 9,265,762, product and use patent
patent.txt line 4,675- Expiry as listed
- 29 May 2027
- Rule
- R1
- Flags
- product · use code U-1820
- Product numbers
- 001
US 9,265,762 with pediatric exclusivity, as listed
patent.txt line 4,674- Expiry as listed
- 29 Nov 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 8,367,685, product and use patent
patent.txt line 4,673- Expiry as listed
- 4 Oct 2028
- Rule
- R1
- Flags
- product · use code U-1445
- Product numbers
- 001
US 8,367,685 with pediatric exclusivity, as listed
patent.txt line 4,672- Expiry as listed
- 4 Apr 2029
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 8,268,847, use patent
patent.txt line 4,671- Expiry as listed
- 18 Apr 2029
- Rule
- R1
- Flags
- use code U-1446
- Product numbers
- 001
US 8,268,847 with pediatric exclusivity, as listed
patent.txt line 4,670- Expiry as listed
- 18 Oct 2029
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
Listed exclusivities
Each exclusivity FDA lists for NDA 204410, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-187 exclusivity
exclusivity.txt line 426- Date
- 28 Feb 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
PED exclusivity
exclusivity.txt line 427- Date
- 28 Aug 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 204410
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 204410, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 204410
Macitentan · Tablets · 10 mg
RLD/NDA as listed: Opsumit 204410- First PIV submission
- 18 Oct 2017
- ANDAs
- 11
- 180-day status
- Eligible
- Decision posted
- 4 May 2021
- First applicant approval
- 6 Apr 2021
- First marketing
- 6 Jun 2026
- Last qualifying patent expiry (as listed by FDA)
- 18 Apr 2029
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