FDA Orange Book · active-ingredient family
Cyclophosphamide
Cyclophosphamide: 8 brands, 23 generics; first approved Feb 16, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 23 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
8
Generics (ANDA)
23
Listed patents
5
Next patent expiry
Jun 26, 2035
in 8 yr 10 mo
Brand (NDA) products
Originator applications
- CYCLOPHOSPHAMIDERLDRSSANDOZNDA 21715020233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Rx — 2GM/20ML (100MG/ML) SOLUTION INTRAVENOUS Rx — - CYCLOPHOSPHAMIDERLDRSBAXTER HLTHCARE CORPNDA 21765120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/2.5ML (200MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/5ML (200MG/ML) SOLUTION INTRAVENOUS Rx — - AVYXA HOLDINGSNDA 21085220233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/ML (500MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/2ML (500MG/ML) SOLUTION INTRAVENOUS Rx — 2GM/4ML (500MG/ML) SOLUTION INTRAVENOUS Rx — - CYCLOPHOSPHAMIDERLDRSEUGIA PHARMA SPECLTSNDA 21073520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/2.5ML (200MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/5ML (200MG/ML) SOLUTION INTRAVENOUS Rx — 2GM/10ML (200MG/ML) SOLUTION INTRAVENOUS Rx — - CYCLOPHOSPHAMIDERLDRSDR REDDYSNDA 21250120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/2.5ML (200MG/ML) SOLUTION INTRAVENOUS Rx AP 1GM/5ML (200MG/ML) SOLUTION INTRAVENOUS Rx AP 2GM/10ML (200MG/ML) SOLUTION INTRAVENOUS Rx — - CYCLOPHOSPHAMIDERLDHIKMANDA 20385620132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYTOXANRLDBAXTER HLTHCARENDA 012142—10 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 200MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — 100MG/VIAL INJECTABLE INJECTION Discontinued — 200MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — - CYTOXANRLDBAXTER HLTHCARENDA 012141—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx — 25MG TABLET ORAL Rx —
Generic (ANDA) products (23)
Abbreviated applications
- CYCLOPHOSPHAMIDEHAINAN POLYANDA 21863220243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDEEPIC PHARMA LLCANDA 21864420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDEEIRGENANDA 21828220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYCLOPHOSPHAMIDENEXUSANDA 21678320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/2.5ML (200MG/ML) SOLUTION INTRAVENOUS Rx AP 1GM/5ML (200MG/ML) SOLUTION INTRAVENOUS Rx AP - CYCLOPHOSPHAMIDEHIKMAANDA 21695820233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDEZYDUS LIFESCIENCESANDA 21155220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYCLOPHOSPHAMIDESUNNYANDA 21508920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDESAGENT PHARMS INCANDA 21452920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDEALEMBICANDA 21589220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYCLOPHOSPHAMIDEXGEN PHARMSANDA 21175720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDECIPLAANDA 21160820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYCLOPHOSPHAMIDEAMNEALANDA 21004620183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDESENORES PHARMSANDA 20987220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - CYCLOPHOSPHAMIDEANI PHARMSANDA 20701420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - CYCLOPHOSPHAMIDEHENGRUI PHARMAANDA 20455520143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDERSBAXTER HLTHCAREANDA 04074520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP 2GM/VIAL INJECTABLE INJECTION Rx AP - CYCLOPHOSPHAMIDEROXANEANDA 04003219992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - TEVA PARENTERALANDA 04001519935 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 200MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued — - CYCLOPHOSPHAMIDEBAXTER HLTHCAREANDA 0883741986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Discontinued — - CYCLOPHOSPHAMIDEBAXTER HLTHCAREANDA 0883711986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - CYCLOPHOSPHAMIDEBAXTER HLTHCAREANDA 0883721986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/VIAL INJECTABLE INJECTION Discontinued — - CYCLOPHOSPHAMIDEBAXTER HLTHCAREANDA 0883731986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — - BEDFORDANDA 08744219835 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 200MG/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — 2GM/VIAL INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9662342 | in 8 yr 10 mo | Product | |
| 10849916 | in 8 yr 11 mo | Product | |
| 11382923 | in 9 yr 3 mo | Product | |
| 10993952 | in 9 yr 6 mo | Product | |
| 12329767 | in 9 yr 6 mo | Product |
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
1 yr 10 mo ago
Approvals span 1982–2024 across 31 FDA applications.
Brand (NDA) 826%
Generic (ANDA) 2374%
Cyclophosphamide: 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.
