FDA Orange Book · active-ingredient family
Adenosine
Adenosine: 2 brands, 21 generics; first approved Oct 30, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
21
Listed patents
0
Presentations
31
Brand (NDA) products
Originator applications
- ADENOSCANRLDASTELLASNDA 02005919952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Discontinued — 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Discontinued — - ADENOCARDRLDASTELLASNDA 0199371989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (21)
Abbreviated applications
- ADENOSINEFRESENIUS KABI USAANDA 2055682018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEGLANDANDA 2067782018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEFRESENIUS KABI USAANDA 07789720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINEEUGIA PHARMAANDA 20533120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINERISINGANDA 09045020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINEAVET LIFESCIENCESANDA 20231320142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINEMYLAN ASIANDA 09021220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINEHOSPIRAANDA 20388320142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Discontinued — 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Discontinued — - ADENOSINEPHARMOBEDIENTANDA 0786402014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued — - ADENOSINERSMEITHEALANDA 07742520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/20ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP 90MG/30ML (3MG/ML) SOLUTION INTRAVENOUS Rx AP - ADENOSINEWOCKHARDTANDA 0902202009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued — - ADENOSINEMYLAN LABS LTDANDA 0786862009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEAM REGENTANDA 0900102009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued — - ADENOSINERSRISINGANDA 0780762008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINETEVA PHARMS USAANDA 0786762008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued — - ADENOSINEGLAND PHARMA LTDANDA 0772832007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEFRESENIUS KABI USAANDA 0771332005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEHIKMAANDA 0764042004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEHIKMAANDA 0765002004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Rx AP - ADENOSINEHIKMAANDA 0765012004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued — - ADENOSINETEVA PHARMS USAANDA 0765642004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
37 yr 3 mo ago
Most recent approval
8 yr 5 mo ago
Approvals span 1989–2018 across 23 FDA applications.
Brand (NDA) 29%
Generic (ANDA) 2191%
Adenosine: 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.

