Question 1

Is there a generic for Trilaciclib dihydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Trilaciclib dihydrochloride?

Accepted Answer

COSELA (NDA 214200, PHARMACOSMOS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Trilaciclib dihydrochloride?

Accepted Answer

The Orange Book lists 14 patents against Trilaciclib dihydrochloride 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 Trilaciclib dihydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Trilaciclib dihydrochloride is approved in the following dosage form: powder.

Patent	Expires	In	Type
11040042	Oct 25, 2031	in 5 yr 5 mo	Product
10189850	Oct 25, 2031	in 5 yr 5 mo	Product
10189849	Oct 25, 2031	in 5 yr 5 mo	Substance
10927120	Oct 25, 2031	in 5 yr 5 mo	Product
9957276	Oct 25, 2031	in 5 yr 5 mo	Substance
8598197	Oct 25, 2031	in 5 yr 5 mo	SubstanceProduct
9487530	Mar 14, 2034	in 7 yr 10 mo	U-3079
10085992	Mar 14, 2034	in 7 yr 10 mo	U-3081
11717523	Mar 14, 2034	in 7 yr 10 mo	U-3678
10966984	Mar 14, 2034	in 7 yr 10 mo	U-3079
8598186	Dec 30, 2034	in 8 yr 8 mo	SubstanceProduct
12527798	Dec 05, 2037	in 11 yr 8 mo	U-3504
11529352	Jul 23, 2039	in 13 yr 3 mo	U-3504
12168666	Nov 13, 2040	in 14 yr 7 mo	SubstanceProduct

Trilaciclib dihydrochloride

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (14)

Trilaciclib dihydrochloride — frequently asked questions

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