Drybench Patent.
FDA Paragraph IV list: U
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with U, grouped by the NDA number the list gives.
FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.
FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.
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.
Ubrogepant
NDA 211765 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 50 mg and 100 mg
RLD/NDA as listed: Ubrelvy 211765- First PIV submission
- 26 Dec 2023
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Dec 2041
Ulipristal Acetate
NDA 022474 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 30 mg
RLD/NDA as listed: Ella 22474- First PIV submission
- 13 Aug 2014
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Aug 2020
- First applicant approval
- 13 Feb 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Jun 2030
Unoprostone Isopropyl
NDA 021214 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 1.5E-3
RLD/NDA as listed: Rescula 21214- First PIV submission
- 12 May 2014
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 9 Jul 2021
Upadacitinib
NDA 211675 · 3 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 15 mg
RLD/NDA as listed: Rinvoq 211675- First PIV submission
- 16 Aug 2023
- ANDAs
- 5
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 9 Mar 2038
Extended-release Tablets · 30 mg
RLD/NDA as listed: Rinvoq 211675- First PIV submission
- 16 Aug 2023
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 9 Mar 2038
Extended-release Tablets · 45 mg
RLD/NDA as listed: Rinvoq 211675- First PIV submission
- 16 Aug 2023
- ANDAs
- 3
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 9 Mar 2038
Upadacitinib
NDA 218347 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 1 mg/mL
RLD/NDA as listed: Rinvoq LQ 218347- First PIV submission
- 2 Mar 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Oct 2036