FDA Orange Book · active-ingredient family
Regadenoson
Regadenoson: 1 brand, 13 generics; first approved Apr 10, 2008; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
2
Next patent expiry
Feb 02, 2027
in 5 mo
Brand (NDA) products
Originator applications
- ASTELLASNDA 0221612008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (13)
Abbreviated applications
- REGADENOSONINDIES PHARMAANDA 2180542024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONGE HEALTHCAREANDA 2159552024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Discontinued — - REGADENOSONBAXTER HLTHCARE CORPANDA 2174552023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONMYLANANDA 2138562023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONHIKMAANDA 2158272023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONEUGIA PHARMAANDA 2164372022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONHOSPIRAANDA 2143492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONGLANDANDA 2073202022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONIMS LTDANDA 2142522022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONACCORD HLTHCAREANDA 2132362022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONAPOTEXANDA 2076042022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONDR REDDYSANDA 2132102022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP - REGADENOSONMEITHEALANDA 2128062022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/5ML (0.08MG/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8106183 | in 5 mo | Substance | |
| RE47301 | in 5 mo | Product |
Approval history
FDA approval span
First approval
18 yr 8 mo ago
Most recent approval
2 yr ago
Approvals span 2008–2024 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Regadenoson: 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.
