FDA Orange Book · active-ingredient family
Posaconazole
Posaconazole: 4 brands, 21 generics; first approved Sep 15, 2006; generic available.
Generic available5 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
4
Generics (ANDA)
21
Listed patents
6
Next patent expiry
Mar 13, 2029
in 2 yr 8 mo
Brand (NDA) products
Originator applications
- MSD MERCK CONDA 2147702021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG FOR SUSPENSION, DELAYED RELEASE ORAL Rx — - NOXAFILRLDMERCK SHARP DOHMENDA 2055962014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Discontinued — - NOXAFILRLDMERCK SHARP DOHMENDA 2050532013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Discontinued — - SCHERINGNDA 0220032006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Rx AB
Generic (ANDA) products (21)
Abbreviated applications
- POSACONAZOLEAPOTEXANDA 2133312026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEQILU PHARM HAINANANDA 2177202025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEMSNANDA 2184342025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEASPIROANDA 2190572024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLEAUROBINDO PHARMAANDA 2171192024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEEUGIA PHARMAANDA 2148422023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLEFRESENIUS KABI USAANDA 2099832023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLERSGLANDANDA 2175532023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLEMYLAN LABS LTDANDA 2115002023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLEI 3 PHARMSANDA 2164882023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEWELDINGANDA 2163262023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEAMNEALANDA 2166262022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEHETERO LABS LTD IIIANDA 2143212022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEACTAVIS LABS FL INCANDA 2073552022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Discontinued — - POSACONAZOLEPH HEALTHANDA 2087682022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/16.7ML (18MG/ML) SOLUTION INTRAVENOUS Rx AP - POSACONAZOLESPECGX LLCANDA 2122262022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEDR REDDYSANDA 2125002022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEBIOCON PHARMAANDA 2144762022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLERSAET PHARMAANDA 2134542021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB - POSACONAZOLEHIKMAANDA 2087732020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML SUSPENSION ORAL Rx AB - POSACONAZOLESINOTHERAPEUTICS INCANDA 2124112019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, DELAYED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-984New indication exclusivity (3 years)
in 2 yr 6 mo
- NPPNew patient population exclusivity (3 years)
in 2 yr 6 mo
- ODE-355Orphan-drug exclusivity (7 years)
in 1 yr 11 mo
- NPPNew patient population exclusivity (3 years)
in 2 yr 6 mo
- ODE-355Orphan-drug exclusivity (7 years)
in 1 yr 11 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9750822 | in 2 yr 8 mo | Product | |
| 10117951 | in 2 yr 8 mo | Product | |
| 8410077 | in 2 yr 8 mo | Product | |
| 9358297 | in 5 yr | ProductU-3171 | |
| 9023790 | in 5 yr | ProductU-3171 | |
| 9493582 | in 6 yr 8 mo | Product |
Approval history
FDA approval span
First approval
20 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 2006–2026 across 25 FDA applications.
Brand (NDA) 416%
Generic (ANDA) 2184%
Posaconazole: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
