Question 1

Is there a generic for Acoltremon?

Accepted Answer

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

Question 2

What is the reference-listed drug for Acoltremon?

Accepted Answer

TRYPTYR (NDA 217370, ALCON LABS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Acoltremon?

Accepted Answer

The Orange Book lists 5 patents against Acoltremon products, with the earliest listed expiry in 2031. 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 Acoltremon have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Acoltremon is approved in the following dosage form: solution/drops.

Patent	Expires	In	Type
10028920	Sep 08, 2031	in 5 yr 4 mo	U-1900
9433679	Sep 08, 2031	in 5 yr 4 mo	U-1900
9095609	Sep 08, 2031	in 5 yr 4 mo	ProductU-1900
11850221	Dec 16, 2042	in 16 yr 9 mo	ProductU-1900
12336971	Dec 16, 2042	in 16 yr 9 mo	U-1900

Acoltremon

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (5)

Acoltremon — frequently asked questions

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