Question 1

Is there a generic for Posaconazole?

Accepted Answer

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Posaconazole, referencing the brand NOXAFIL POWDERMIX KIT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Posaconazole?

Accepted Answer

NOXAFIL POWDERMIX KIT (NDA 214770, MSD MERCK CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Posaconazole?

Accepted Answer

The Orange Book lists 6 patents against Posaconazole 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 Posaconazole have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Posaconazole. 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 Posaconazole are approved?

Accepted Answer

Posaconazole is approved in the following dosage forms: for suspension, delayed release, solution, suspension, tablet, delayed release.

Product	Applicant	Application	TE	Approved
NOXAFIL POWDERMIX KITRLD	MSD MERCK CO	NDA 214770	—	May 31, 2021
NOXAFILRLD	MERCK SHARP DOHME	NDA 205596	—	Mar 13, 2014
NOXAFILRLD	MERCK SHARP DOHME	NDA 205053	—	Nov 25, 2013
NOXAFILRLD	SCHERING	NDA 022003	AB	Sep 15, 2006

Product	Applicant	Application	TE	Approved
POSACONAZOLE	QILU PHARM HAINAN	ANDA 217720	AB	Apr 23, 2025
POSACONAZOLE	MSN	ANDA 218434	AB	Feb 24, 2025
POSACONAZOLE	ASPIRO	ANDA 219057	AP	Dec 23, 2024
POSACONAZOLE	AUROBINDO PHARMA	ANDA 217119	AB	Jul 18, 2024
POSACONAZOLE	EUGIA PHARMA	ANDA 214842	AP	Dec 26, 2023
POSACONAZOLE	FRESENIUS KABI USA	ANDA 209983	AP	Dec 26, 2023
POSACONAZOLE	GLAND	ANDA 217553	AP	Dec 26, 2023
POSACONAZOLE	MYLAN LABS LTD	ANDA 211500	AP	Dec 26, 2023
POSACONAZOLE	I 3 PHARMS	ANDA 216488	AB	Aug 28, 2023
POSACONAZOLE	WELDING	ANDA 216326	AB	Jun 20, 2023
POSACONAZOLE	AMNEAL	ANDA 216626	AB	Dec 22, 2022
POSACONAZOLE	HETERO LABS LTD III	ANDA 214321	AB	Dec 08, 2022
POSACONAZOLE	ACTAVIS LABS FL INC	ANDA 207355	—	Nov 30, 2022
POSACONAZOLE	PH HEALTH	ANDA 208768	AP	May 25, 2022
POSACONAZOLE	SPECGX LLC	ANDA 212226	AB	May 10, 2022
POSACONAZOLE	DR REDDYS	ANDA 212500	AB	Apr 07, 2022
POSACONAZOLE	BIOCON PHARMA	ANDA 214476	AB	Feb 04, 2022
POSACONAZOLE	AET PHARMA	ANDA 213454	AB	Feb 01, 2021
POSACONAZOLE	HIKMA	ANDA 208773	AB	May 15, 2020
POSACONAZOLE	SINOTHERAPEUTICS INC	ANDA 212411	AB	Aug 21, 2019

Patent	Expires	In	Type
9750822	Mar 13, 2029	in 2 yr 9 mo	Product
10117951	Mar 13, 2029	in 2 yr 9 mo	Product
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
9358297	Jun 24, 2031	in 5 yr 1 mo	ProductU-3171
9023790	Jul 04, 2031	in 5 yr 1 mo	ProductU-3171
9493582	Feb 27, 2033	in 6 yr 10 mo	Product

Posaconazole

Brand (NDA) products · for suspension, delayed release, solution, suspension, tablet, delayed release

Generic (ANDA) products (20)

Marketing exclusivity (5)

Listed patents (6)

Posaconazole — frequently asked questions

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