FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride: 2 brands, 0 generics; first approved Dec 19, 2002; on patent until Feb 28, 2027.
On patent
Generic status & protection
Protected until Feb 28, 2027 (earliest listed patent expiry).
Earliest patent expiry Feb 28, 2027
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Feb 28, 2027
in 8 mo
Originator applications
Brand (NDA) products
HALEON US HOLDINGSNDA 0215872004
HALEON US HOLDINGSNDA 0215872004
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/5ML;100MG/5ML;15MG/5ML | SUSPENSION | ORAL | OTC | — |
HALEON US HOLDINGSNDA 0214412002
HALEON US HOLDINGSNDA 0214412002
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG;200MG;30MG | TABLET | ORAL | OTC | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Orange Book patent file
Listed patents
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7863287 | Feb 28, 2027 | in 8 mo | Product |
FDA approval span
Approval history
First approval
Dec 19, 2002
23 yr 11 mo ago
Most recent approval
Feb 24, 2004
22 yr 9 mo ago
Approvals span 2002–2004 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
