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NDA

BUPIVACAINE | N204803 | INNOCOLL PHARMACEUTICALS LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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11400019

Jan. 12, 2041

11771624

Jan. 12, 2041

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SABUPIVACAINE HCL

DMF 29111977

SIEGFRIED EVIONNAZ SABUPIVACAINE BASE

DMF 119381996

CAMBREX KARLSKOGA ABBUPIVACAINE BASE

DMF 191772006

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE

DMF 323692017

NORTEC QUIMICA SABUPIVACAINE

DMF 332852018

JIANGSU HENGRUI PHARMACEUTICALS CO LTDBUPIVACAINE BASE

DMF 349002020

MSN LIFE SCIENCES PRIVATE LTDBUPIVACAINE

DMF 353222020

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDBUPIVACAINE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 402732024

HAICHANG BIOTECH CO LTDBUPIVACAINE

DMF 411352025

EXCELLA GMBHInactiveBUPIVACAINE (S) HYDROCHLORIDE

DMF 250902011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 4, 2022	SUPPL -1	View Letter (PDF)
Feb 3, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 660MG/5ML (132MG/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INFILTRATION | Approved: Feb 1, 2021

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11400019	Jan 12, 2041	—	—	Yes	—	—
11771624	Jan 12, 2041	—	—	—		—