FDA Orange Book · active-ingredient family
Calcipotriene
Calcipotriene: 4 brands, 8 generics; first approved Dec 29, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
8
Listed patents
2
Next patent expiry
May 26, 2026
3 mo ago
Brand (NDA) products
Originator applications
- MAYNE PHARMANDA 0225632010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% AEROSOL, FOAM TOPICAL Rx — - DOVONEXRLDLEO PHARMNDA 0206111997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Discontinued — - LEO PHARMA ASNDA 0205541996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% CREAM TOPICAL Rx AB - DOVONEXRLDLEO PHARMA ASNDA 0202731993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% OINTMENT TOPICAL Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- CALCIPOTRIENECHARTWELL RXANDA 2071632017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Rx AT - CALCIPOTRIENEGLENMARK SPECLTANDA 2057722015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% CREAM TOPICAL Rx AB - CALCIPOTRIENECHARTWELL RXANDA 2009352012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% CREAM TOPICAL Discontinued — - CALCIPOTRIENERSCOSETTE PHARMS NCANDA 0784682011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Rx AT - CALCIPOTRIENERSGLENMARK PHARMSANDA 0906332010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% OINTMENT TOPICAL Rx AB - CALCIPOTRIENECHARTWELL RXANDA 0770292009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Discontinued — - CALCIPOTRIENEHIKMAANDA 0775792009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Discontinued — - CALCIPOTRIENEFOUGERA PHARMSANDA 0783052008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005% SOLUTION TOPICAL Rx AT
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8629128 | 3 mo ago | ProductU-1280 | |
| 8263580 | in 1 yr 9 mo | ProductU-1280 |
Approval history
FDA approval span
First approval
33 yr 1 mo ago
Most recent approval
8 yr 9 mo ago
Approvals span 1993–2017 across 12 FDA applications.
Brand (NDA) 433%
Generic (ANDA) 867%
Calcipotriene: 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.
