FDA Orange Book · active-ingredient family
Ranolazine
Ranolazine: 2 brands, 27 generics; first approved Jan 27, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
27
Listed patents
3
Next patent expiry
Jan 24, 2038
in 11 yr 6 mo
Brand (NDA) products
Originator applications
- SPILNDA 21601820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG GRANULE, EXTENDED RELEASE ORAL Discontinued — 1GM GRANULE, EXTENDED RELEASE ORAL Discontinued — - RANEXARLDMENARINI INTLNDA 02152620072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — 500MG TABLET, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (27)
Abbreviated applications
- RANOLAZINEUMEDICAANDA 21455120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEJUBILANT GENERICSANDA 21136120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINETORRENTANDA 21040720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINENOVAST LABSANDA 21066820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEPIRAMALANDA 21308520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEUNICHEMANDA 21308320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEAUROBINDO PHARMAANDA 20908120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEHETERO LABS LTD IIIANDA 21278820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEI3 PHARMSANDA 21351720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEVKT PHARMAANDA 21403520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEACCORD HLTHCAREANDA 21293020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINEAMNEALANDA 20769020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINERISINGANDA 21288920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEALKEM LABS LTDANDA 20995320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEARTHUR GRPANDA 21278120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINESUNSHINEANDA 21186520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEMICRO LABSANDA 21174520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEMANKIND PHARMAANDA 21228420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEANI PHARMSANDA 21048220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINERSCADILAANDA 21018820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEGLENMARK PHARMS LTDANDA 21108220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINESCIEGEN PHARMSANDA 21182920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINEACTAVIS ELIZABETHANDA 20886220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINEAJANTA PHARMA LTDANDA 21005420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB - RANOLAZINECIPLAANDA 21129120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINESUN PHARMANDA 21170720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - RANOLAZINECHARTWELL RXANDA 20104620132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 1GM TABLET, EXTENDED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11510878 | in 11 yr 6 mo | Product | |
| 12161761 | in 11 yr 6 mo | Product | |
| 10898444 | in 11 yr 6 mo | Product |
Approval history
FDA approval span
First approval
20 yr 11 mo ago
Most recent approval
1 mo ago
Approvals span 2006–2026 across 29 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2793%
Ranolazine: 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.
