FDA Orange Book · active-ingredient family
Carbinoxamine maleate
Carbinoxamine maleate: 3 brands, 10 generics; first approved Mar 19, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
10
Listed patents
2
Next patent expiry
Jun 15, 2027
in 10 mo
Brand (NDA) products
Originator applications
- AYTUNDA 0225562013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/5ML SUSPENSION, EXTENDED RELEASE ORAL Rx — - CLISTINRLDMCNEILNDA 008955—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/5ML ELIXIR ORAL Discontinued — - CLISTINRLDORTHO MCNEIL PHARMNDA 008915—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- CARBINOXAMINE MALEATELEADINGANDA 2154762024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB - CARBINOXAMINE MALEATERSMIKARTANDA 2074842016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx AB - CARBINOXAMINE MALEATEMISSION PHARMACALANDA 0907562011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA - CARBINOXAMINE MALEATECYPRESS PHARMANDA 0904172010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CARBINOXAMINE MALEATECYPRESS PHARMANDA 0904182010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/5ML SOLUTION ORAL Discontinued — - CARBINOXAMINE MALEATESENORES PHARMSANDA 0904352010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CARBINOXAMINE MALEATESTRIDES PHARMA INTLANDA 0406392008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - CARBINOXAMINE MALEATEPH HEALTHANDA 0408142008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/5ML SOLUTION ORAL Discontinued — - CARBINOXAMINE MALEATERSGENUSANDA 0404582003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG/5ML SOLUTION ORAL Rx — - CARBINOXAMINE MALEATERSGENUSANDA 0404422003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AA
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9522191 | in 10 mo | Product | |
| 8062667 | in 2 yr 8 mo | Product |
Approval history
FDA approval span
First approval
23 yr 9 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 2003–2024 across 13 FDA applications.
Brand (NDA) 323%
Generic (ANDA) 1077%
Carbinoxamine maleate: 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.
