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BUPIVACAINE HYDROCHLORIDE

NDA

BUPIVACAINE HYDROCHLORIDE | N018053 | HOSPIRA INC

3 strengths0 unique patents0 unique exclusivities

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Abbott Laboratories FDA-1988-P-0375 · 7 docket documents Abbott Laboratories submitted a petition on June 7, 1988, requesting ANDA status for 0.125% Bupivacaine Hydrochloride Injection, USP in 100 mL PVC flexible containers containing 125 mg total drug per container. The proposed product is identical in formulation, usage, and total drug amount to current	Other	2017-06-28	Withdrawn	Abbott Laboratories

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

500 trials from ClinicalTrials.gov — 8 recruiting, 5 active, 378 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Intralipid® 20% for Reversal of Local Anesthetics NCT03968822	Phase 4	Active	Hospital for Special Surgery, New York	18	2019-07-26 → 2026-10
Effect of Addition of Steroids on Duration of Analgesia NCT04126824	Early Phase 1	Active	University of California, Los Angeles	28	2022-01-06 → 2027-08-02
Exparel Injection for Postoperative Orbital Pain NCT02381353	Phase 4	Active	Mayo Clinic	88	2015-02 → 2026-12
Functional Endoscopic Sinus Surgery Study NCT03970655	Phase 1/2	Active	University of Florida	80	2019-09-25 → 2027-01-23
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery NCT03214510	Phase 3	Active	M.D. Anderson Cancer Center	101	2017-10-04 → 2026-07-31
Exparel Injection Effect on Postoperative Opioid Usage NCT04085913	Early Phase 1	By Invitation	University of Missouri-Columbia	100	2019-09-30 → 2025-07
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery NCT04260854	Phase 1	By Invitation	Northwestern University	100	2024-01-24 → 2028-12
Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine NCT04003506	Phase 4	Not Yet Recruiting	The University of Hong Kong	90	2024-03-01 → 2026-10
Spinal Anesthesia For Enhanced Recovery After Liver Surgery NCT03715517	N/A	Recruiting	University of Manitoba	128	2018-10-04 → 2031-12-31
Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine NCT04066296	Phase 2	Recruiting	University of Colorado, Denver	100	2019-09-08 → 2025-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs1 inactive

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

CAMBREX KARLSKOGA ABBUPIVACAINE HYDROCHLORIDE

DMF 59841985

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLBUPIVACAINE HYDROCHLORIDE

DMF 64951986

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE HYDROCHLORIDE

DMF 209592007

EXCELLA GMBH AND CO KGBUPIVACAINE HYDROCHLORIDE

DMF 211962007

MOEHS IBERICA SLBUPIVACAINE HYDROCHLORIDE

DMF 222282008

APEX HEALTHCARE LTDBUPIVACAINE HYDROCHLORIDE USP

DMF 423242025

FRESENIUS KABI ONCOLOGY LTDInactiveBUPIVACAINE HYDROCHLORIDE

DMF 266492012

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 10, 2021	SUPPL -61	View Letter (PDF)
Nov 7, 2018	SUPPL -60	View Letter (PDF)
Jul 13, 2015	SUPPL -55	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.25%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 0.75%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982