FDA Orange Book · active-ingredient family
Bivalirudin
Bivalirudin: 3 brands, 11 generics; first approved Dec 15, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
11
Listed patents
8
Next patent expiry
Jul 27, 2028
in 1 yr 11 mo
Brand (NDA) products
Originator applications
- MAIA PHARMS INCNDA 2112152019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/50ML (5MG/ML) SOLUTION INTRAVENOUS Rx — - BAXTER HLTHCARE CORPNDA 20837420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/50ML (5MG/ML) SOLUTION INTRAVENOUS Discontinued — 500MG/100ML (5MG/ML) SOLUTION INTRAVENOUS Discontinued — - SANDOZNDA 0208732000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP
Generic (ANDA) products (11)
Abbreviated applications
- BIVALIRUDINSLATE RUN PHARMAANDA 2130782021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINSHUANGCHENGANDA 2100312019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINEUGIA PHARMAANDA 2059622018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - BIVALIRUDINMEITHEALANDA 0916022018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINMYLAN INSTITUTIONALANDA 2024712018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINACCORD HLTHCAREANDA 2065512017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINAPOTEXANDA 2048762017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - BIVALIRUDINDR REDDYSANDA 2015772017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINFRESENIUS KABI USAANDA 0901892016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Rx AP - BIVALIRUDINHOSPIRAANDA 0908112015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - BIVALIRUDINHOSPIRAANDA 0908162015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL INJECTABLE INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7582727 | in 1 yr 11 mo | Product | |
| 7598343 | in 1 yr 11 mo | Product | |
| 7582727*PED | in 2 yr 6 mo | ||
| 7598343*PED | in 2 yr 6 mo | ||
| 11903993 | in 12 yr 11 mo | U-3817 | |
| 12472224 | in 12 yr 11 mo | ProductU-3817 | |
| 11918622 | in 12 yr 11 mo | U-3817 | |
| 11992514 | in 12 yr 11 mo | Product |
Approval history
FDA approval span
First approval
26 yr 1 mo ago
Most recent approval
5 yr 4 mo ago
Approvals span 2000–2021 across 14 FDA applications.
Brand (NDA) 321%
Generic (ANDA) 1179%
Bivalirudin: 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.
