Question 1

Is there a generic for Eravacycline dihydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Eravacycline dihydrochloride?

Accepted Answer

XERAVA (NDA 211109, TETRAPHASE PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Eravacycline dihydrochloride?

Accepted Answer

The Orange Book lists 4 patents against Eravacycline dihydrochloride 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.

Question 4

Does Eravacycline dihydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Eravacycline 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 Eravacycline dihydrochloride are approved?

Accepted Answer

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

Patent	Expires	In	Type
8796245	Aug 07, 2029	in 3 yr 2 mo	U-2380
8906887	Aug 27, 2032	in 6 yr 3 mo	Product
11578044	Oct 19, 2037	in 11 yr 6 mo	Substance
10961190	Oct 19, 2037	in 11 yr 6 mo	Substance

Eravacycline dihydrochloride

Brand (NDA) products · powder

Marketing exclusivity (4)

Listed patents (4)

Eravacycline dihydrochloride — frequently asked questions

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