Question 1

Is there a generic for Indigotindisulfonate sodium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Indigotindisulfonate sodium. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Indigotindisulfonate sodium?

Accepted Answer

BLUDIGO (NDA 216264, PROVEPHARM SAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Indigotindisulfonate sodium?

Accepted Answer

The Orange Book lists 3 patents against Indigotindisulfonate sodium products, with the earliest listed expiry in 2036. 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 Indigotindisulfonate sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Indigotindisulfonate sodium. 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 Indigotindisulfonate sodium are approved?

Accepted Answer

Indigotindisulfonate sodium is approved in the following dosage form: solution.

Patent	Expires	In	Type
11845867	Nov 25, 2036	in 10 yr 7 mo	Substance
10927258	Dec 23, 2037	in 11 yr 8 mo	Substance
11499050	Dec 23, 2037	in 11 yr 8 mo	Substance

Indigotindisulfonate sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (3)

Indigotindisulfonate sodium — frequently asked questions

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