Question 1

Is there a generic for Bupivacaine?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Bupivacaine, referencing the brand POSIMIR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Bupivacaine?

Accepted Answer

POSIMIR (NDA 204803, INNOCOLL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Bupivacaine?

Accepted Answer

The Orange Book lists 23 patents against Bupivacaine products, with the earliest listed expiry in 2041. 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.

Question 4

Does Bupivacaine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Bupivacaine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Bupivacaine are approved?

Accepted Answer

Bupivacaine is approved in the following dosage forms: injectable, liposomal, solution.

Product	Applicant	Application	TE	Approved
POSIMIRRLD	INNOCOLL	NDA 204803	—	Feb 01, 2021
EXPARELRLD×2	PACIRA PHARMS INC	NDA 022496	—	Oct 28, 2011

Patent	Expires	In	Type
11771624	Jan 12, 2041	in 14 yr 9 mo	U-3724
11400019	Jan 12, 2041	in 14 yr 9 mo	Product
11452691	Jan 22, 2041	in 14 yr 10 mo	ProductU-3439
11819575	Jan 22, 2041	in 14 yr 10 mo	ProductU-3250
11033495	Jan 22, 2041	in 14 yr 10 mo	ProductU-3182
12144890	Jan 22, 2041	in 14 yr 10 mo	ProductU-4033
11179336	Jan 22, 2041	in 14 yr 10 mo	ProductU-3250
11426348	Jan 22, 2041	in 14 yr 10 mo	ProductU-3380
12296047	Jan 22, 2041	in 14 yr 10 mo	ProductU-4184
11357727	Jan 22, 2041	in 14 yr 10 mo	ProductU-3380
11311486	Jan 22, 2041	in 14 yr 10 mo	ProductU-3250
11278494	Jan 22, 2041	in 14 yr 10 mo	ProductU-3250
11304904	Jan 22, 2041	in 14 yr 10 mo	ProductU-3346
11819574	Jan 22, 2041	in 14 yr 10 mo	ProductU-3250
11925706	Jan 22, 2041	in 14 yr 10 mo	ProductU-3380
12151024	Jan 22, 2041	in 14 yr 10 mo	ProductU-4037
11931459	Mar 17, 2042	in 16 yr	U-3839
12226610	Feb 02, 2043	in 16 yr 10 mo	U-4148
11918565	Feb 02, 2043	in 16 yr 10 mo	U-3841
12318483	Jul 02, 2044	in 18 yr 4 mo	U-4152
12370142	Jul 02, 2044	in 18 yr 4 mo	ProductU-4152
12251468	Jul 02, 2044	in 18 yr 4 mo	ProductU-4152
12156940	Jul 02, 2044	in 18 yr 4 mo	Product

Bupivacaine

Brand (NDA) products · injectable, liposomal, solution

Generic (ANDA) products (1)

Marketing exclusivity (2)

Listed patents (23)

Bupivacaine — frequently asked questions

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