Drybench Patent.

CARVEDILOL PHOSPHATE, NDA 022012

The patents and exclusivities FDA's Orange Book lists for NDA 022012 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.

Open in the app CARVEDILOL PHOSPHATE in the molecule app

Listed protection

Listed dates run from 11 Sep 2025 to 11 Mar 2026, each by its own rule; no one date stands for this product.

Earliest listed date: 11 Sep 2025US 8,101,209, product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 902, 904, 906, 908
Latest listed date: 11 Mar 2026US 8,101,209 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 901, 903, 905, 907
Latest substance patent: None listed
Latest listed patent: 11 Mar 2026US 8,101,209 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 901, 903, 905, 907
Latest exclusivity: None listed

Products

Each product number FDA lists under NDA 022012, as listed. The sections below name products by these numbers.

Product 001 · COREG CR
Dosage form; route
CAPSULE, EXTENDED RELEASE;ORAL
Strength
10MG
Approval date as listed
20 Oct 2006
Type as listed
RX
Applicant as listed
WAYLIS THERAPEUTICS LLC
Product 002 · COREG CR
Dosage form; route
CAPSULE, EXTENDED RELEASE;ORAL
Strength
20MG
Approval date as listed
20 Oct 2006
Type as listed
RX
Applicant as listed
WAYLIS THERAPEUTICS LLC
Product 003 · COREG CR
Dosage form; route
CAPSULE, EXTENDED RELEASE;ORAL
Strength
40MG
Approval date as listed
20 Oct 2006
Type as listed
RX
Applicant as listed
WAYLIS THERAPEUTICS LLC
Product 004 · COREG CR
Dosage form; route
CAPSULE, EXTENDED RELEASE;ORAL
Strength
80MG
Approval date as listed
20 Oct 2006
Type as listed
RX
Applicant as listed
WAYLIS THERAPEUTICS LLC

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.

2 entries from 8 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,101,209, product patent
patent.txt lines 902, 904, 906, 908
Expiry as listed
11 Sep 2025
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004
US 8,101,209 with pediatric exclusivity, as listed
patent.txt lines 901, 903, 905, 907
Expiry as listed
11 Mar 2026
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004

Listed exclusivities

Each exclusivity FDA lists for NDA 022012, 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 022012.

Paragraph IV list rows giving NDA 022012

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 022012, 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 022012

Carvedilol Phosphate · Extended-release Capsules · 10 mg and 20 mg
RLD/NDA as listed: Coreg CR 22012
First PIV submission
18 Mar 2008
ANDAs
1
180-day status
Deferred
Decision posted
7 Apr 2020
First applicant approval
25 Oct 2017
First marketing
8 Nov 2017
Last qualifying patent expiry (as listed by FDA)
27 Dec 2023
Carvedilol Phosphate · Extended-release Capsules · 40 mg
RLD/NDA as listed: Coreg CR 22012
First PIV submission
21 Dec 2007
ANDAs
1
180-day status
Deferred
Decision posted
7 Apr 2020
First applicant approval
25 Oct 2017
First marketing
8 Nov 2017
Last qualifying patent expiry (as listed by FDA)
27 Dec 2023
Carvedilol Phosphate · Extended-release Capsules · 80 mg
RLD/NDA as listed: Coreg CR 22012
First PIV submission
19 Nov 2007
ANDAs
1
180-day status
Deferred
Decision posted
7 Apr 2020
First applicant approval
25 Oct 2017
First marketing
8 Nov 2017
Last qualifying patent expiry (as listed by FDA)
27 Dec 2023

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