FDA Orange Book · active-ingredient family
Lansoprazole
Lansoprazole: 6 brands, 30 generics; first approved May 10, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 30 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
30
Listed patents
2
Next patent expiry
Apr 21, 2036
in 9 yr 8 mo
Brand (NDA) products
Originator applications
- PERRIGO PHARMA INTLNDA 0223272009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL OTC - - PREVACID IVRLDTAKEDA PHARMS NANDA 0215662004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/VIAL INJECTABLE INTRAVENOUS Discontinued - - PREVACIDRLDTAKEDA PHARMS USANDA 02142820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - PREVACIDRLDTAKEDA PHARMS USANDA 02040619952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEDEXCELNDA 2080252016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL OTC - - TAKEDA PHARMS NANDA 02128120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Discontinued - 30MG/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Discontinued -
Generic (ANDA) products (30)
Abbreviated applications
- LANSOPRAZOLEMACLEODS PHARMSANDA 20867120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLEAUROBINDO PHARMA LTDANDA 20716720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - LANSOPRAZOLEDR REDDYSANDA 21046520212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - LANSOPRAZOLEHETERO LABS LTD IIIANDA 20308320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEALKEM LABS LTDANDA 20739420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEMYLANANDA 20239620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - LANSOPRAZOLEZYDUS PHARMSANDA 20081620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - LANSOPRAZOLENOVITIUM PHARMAANDA 20396420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLELANNETT CO INCANDA 2071572017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLECHARTWELL MOLECULARANDA 20715620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLETEVA PHARMS USAANDA 20878420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Rx AB - LANSOPRAZOLEINVENTIAANDA 20586820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEAJANTA PHARMA LTDANDA 20395720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLEXIROMEDANDA 20320320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEMYLANANDA 2031872016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLENATCOANDA 2033062016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL OTC - - LANSOPRAZOLEKRKA TOVARNA ZDRAVILANDA 09121220132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLESUN PHARMANDA 2026372013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLESUN PHARMANDA 0915092013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLEZYDUS HLTHCAREANDA 20236620132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLENATCO PHARMA LTDANDA 20192120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEAPOTEXANDA 20217620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEDR REDDYS LABS LTDANDA 2021942012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL OTC - - LANSOPRAZOLEGLENMARK PHARMSANDA 2027272012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL OTC - - LANSOPRAZOLEPERRIGO R AND DANDA 2023192012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL OTC - - LANSOPRAZOLEDR REDDYS LABS LTDANDA 09126920102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLEANI PHARMSANDA 07873020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Discontinued - 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Discontinued - - LANSOPRAZOLESANDOZANDA 09033120102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - 30MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - LANSOPRAZOLEMYLAN PHARMS INCANDA 09076320092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB - LANSOPRAZOLETEVA PHARMSANDA 07725520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB 30MG CAPSULE, DELAYED REL PELLETS ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11077055 | in 9 yr 8 mo | Product | |
| 11986554 | in 9 yr 8 mo | Product |
Approval history
FDA approval span
First approval
31 yr 11 mo ago
Most recent approval
2 yr ago
Approvals span 1995–2024 across 36 FDA applications.
Brand (NDA) 617%
Generic (ANDA) 3083%
Lansoprazole: 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.
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