Is there a generic for Bupivacaine hydrochloride?

Yes. The FDA Orange Book lists 29 approved generic (ANDA) applications for Bupivacaine hydrochloride, referencing the brand XARACOLL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bupivacaine hydrochloride?

XARACOLL (NDA 209511, INNOCOLL PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bupivacaine hydrochloride?

The Orange Book lists 2 patents against Bupivacaine hydrochloride products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Bupivacaine hydrochloride are approved?

Bupivacaine hydrochloride is approved in the following dosage forms: implant, injectable.

FDA Orange Book · active-ingredient family

Bupivacaine hydrochloride

Bupivacaine hydrochloride: 6 brands, 29 generics; first approved May 04, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 29 ANDA applications approved.

Earliest patent expiry May 20, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 20, 2029

in 2 yr 10 mo

Brand (NDA) products

Originator applications

XARACOLLRLD
INNOCOLL PHARMSNDA 2095112020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG IMPLANT IMPLANTATION Discontinued —
MARCAINERLDRS
HOSPIRANDA 0186921984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	IMPLANT	IMPLANTATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Rx	AP

MARCAINE HYDROCHLORIDERLDRS

HOSPIRANDA 016964—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	INJECTABLE	INJECTION	Rx	AP
0.5%	INJECTABLE	INJECTION	Rx	AP
0.5%	INJECTABLE	INJECTION	Rx	AP
0.75%	INJECTABLE	INJECTION	Rx	AP
0.25%	INJECTABLE	INJECTION	Rx	AP

SENSORCAINERLD
FRESENIUS KABI USANDA 018304—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE KIT
HOSPIRANDA 01997819923 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.075% INJECTABLE INJECTION Discontinued —
0.114% INJECTABLE INJECTION Discontinued —
0.23% INJECTABLE INJECTION Discontinued —
BUPIVACAINE HYDROCHLORIDE
HOSPIRANDA 018053—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued —
0.25% INJECTABLE INJECTION Discontinued —
0.75% INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.075%	INJECTABLE	INJECTION	Discontinued	—
0.114%	INJECTABLE	INJECTION	Discontinued	—
0.23%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Discontinued	—
0.25%	INJECTABLE	INJECTION	Discontinued	—
0.75%	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (29)

Abbreviated applications

BUPIVACAINE HYDROCHLORIDE
ANTHEA PHARMAANDA 22049320263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
ASPIROANDA 21782120243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
MEITHEALANDA 21604020233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
SOMERSETANDA 21779220232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
MEITHEALANDA 21603920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HIKMA PHARMSANDA 20514120212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
HIKMA PHARMSANDA 20484220213 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HUONSANDA 2128222019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Rx AP
BUPIVACAINE HYDROCHLORIDE
B BRAUN MEDICALANDA 2090872019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Rx AP
BUPIVACAINE HYDROCHLORIDE
CIVICAANDA 2110962019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued —
BUPIVACAINE HYDROCHLORIDE
BAXTER HLTHCARE CORPANDA 2072662016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Discontinued —
BUPIVACAINE HYDROCHLORIDE
EUGIA PHARMAANDA 20718320162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
EUGIA PHARMAANDA 20389520133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
ONESOURCE SPECIALTYANDA 09150320112 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
ONESOURCE SPECIALTYANDA 09148720113 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
0.25% INJECTABLE INJECTION Rx AP
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATEDANDA 07601220023 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Discontinued —
0.5% INJECTABLE INJECTION Discontinued —
0.75% INJECTABLE INJECTION Discontinued —
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0718101987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Rx AP
SENSORCAINE
FRESENIUS KABI USAANDA 0712021987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE SPINAL Discontinued —
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705861987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Discontinued —
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705971987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0706091987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705851987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705871987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE INJECTION Discontinued —
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705831987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705901987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
SENSORCAINE
FRESENIUS KABI USAANDA 0705521986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% INJECTABLE INJECTION Rx AP
SENSORCAINE
FRESENIUS KABI USAANDA 0705531986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
SENSORCAINE
FRESENIUS KABI USAANDA 0705541986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75% INJECTABLE INJECTION Rx AP
BUPIVACAINE HYDROCHLORIDE
HOSPIRAANDA 0705841986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Rx	AP
0.25%	INJECTABLE	INJECTION	Rx	AP
0.75%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	INJECTABLE	INJECTION	Discontinued	—
0.5%	INJECTABLE	INJECTION	Discontinued	—
0.75%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	SPINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Rx	AP

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE47826	May 20, 2029	in 2 yr 10 mo	U-2949
11746141	Jan 09, 2033	in 6 yr 6 mo	Product

Approval history

FDA approval span

First approval

May 04, 1984

42 yr 11 mo ago

Most recent approval

Apr 22, 2026

4 mo ago

Approvals span 1984–2026 across 35 FDA applications.

Brand (NDA) 617%

Generic (ANDA) 2983%

Bupivacaine hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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