Drybench Patent.
ROPIVACAINE HYDROCHLORIDE, NDA 020533
The patents and exclusivities FDA's Orange Book lists for NDA 020533 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 appROPIVACAINE HYDROCHLORIDE in the molecule app
Listed protection
Listed dates run from 28 Nov 2026 to 28 Nov 2026, each by its own rule; no one date stands for this product.
- Earliest listed date
- 28 Nov 2026US 7,857,802, product patentRule R1 · Products 006, 007 · patent.txt lines 186–187
- Latest listed date
- 28 Nov 2026US 7,857,802, product patentRule R1 · Products 006, 007 · patent.txt lines 186–187
- Latest substance patent
- None listed
- Latest listed patent
- 28 Nov 2026US 7,857,802, product patentRule R1 · Products 006, 007 · patent.txt lines 186–187
- Latest exclusivity
- None listed
Products
Each product number FDA lists under NDA 020533, as listed. The sections below name products by these numbers.
Product 001 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 20MG/10ML (2MG/ML)
- Approval date as listed
- 1 May 1998
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 002 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 40MG/20ML (2MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 003 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 100MG/20ML (5MG/ML)
- Approval date as listed
- 1 May 1998
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 004 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 150MG/20ML (7.5MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 005 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 100MG/10ML (10MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 006 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 200MG/100ML (2MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 007 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 400MG/200ML (2MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 008 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 150MG/30ML (5MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 009 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 500MG/100ML (5MG/ML)
- Approval date as listed
- 4 Jan 2011
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 010 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 1GM/200ML (5MG/ML)
- Approval date as listed
- 4 Jan 2011
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 011 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 200MG/20ML (10MG/ML)
- Approval date as listed
- 24 Sep 1996
- Type as listed
- RX
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 012 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 24 Sep 1996
- Type as listed
- DISCN
- Applicant as listed
- FRESENIUS KABI USA LLC
Product 013 · NAROPIN
- Dosage form; route
- SOLUTION;INJECTION
- Strength
- 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 1 May 1998
- Type as listed
- DISCN
- Applicant as listed
- FRESENIUS KABI USA 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.
1 entry from 2 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,857,802, product patent
patent.txt lines 186–187- Expiry as listed
- 28 Nov 2026
- Rule
- R1
- Flags
- product
- Product numbers
- 006, 007
Listed exclusivities
Each exclusivity FDA lists for NDA 020533, 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 020533.
Paragraph IV list rows giving NDA 020533
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 020533, 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 020533
Ropivacaine Hydrochloride · Injection · 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials
RLD/NDA as listed: Naropin 20533- First PIV submission
- 13 Nov 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 23 Mar 2021
- First applicant approval
- 17 Jul 2014
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Sep 2014
Ropivacaine Hydrochloride · Injection · 2 mg/mL, 100 mL
RLD/NDA as listed: Naropin 20533- First PIV submission
- 30 Jan 2015
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 13 Jul 2016
- First marketing
- 15 Sep 2016
- Last qualifying patent expiry (as listed by FDA)
- 28 Nov 2026
Ropivacaine Hydrochloride · Injection · 2 mg/mL, 200 mL
RLD/NDA as listed: Naropin 20533- First PIV submission
- 3 Sep 2015
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Jun 2019
- First applicant approval
- 16 Mar 2018
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Nov 2026
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