FDA Orange Book · active-ingredient family
Lubiprostone
Lubiprostone: 1 brand, 6 generics; first approved Jan 31, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
3
Next patent expiry
Jan 23, 2027
in 3 mo
Brand (NDA) products
Originator applications
- AMITIZARLDSUCAMPO PHARMA LLCNDA 02190820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MCG CAPSULE ORAL Rx AB 8MCG CAPSULE ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- LUBIPROSTONEASCENT PHARMS INCANDA 21864020252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Rx AB 24MCG CAPSULE ORAL Rx AB - LUBIPROSTONEZYDUS PHARMSANDA 21413120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Rx AB 24MCG CAPSULE ORAL Rx AB - LUBIPROSTONEPH HEALTHANDA 20144220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Discontinued — 24MCG CAPSULE ORAL Discontinued — - LUBIPROSTONEDR REDDYSANDA 20699420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Rx AB 24MCG CAPSULE ORAL Rx AB - LUBIPROSTONETEVA PHARMS USA INCANDA 20992020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Rx AB 24MCG CAPSULE ORAL Rx AB - LUBIPROSTONEAMNEALANDA 20945020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MCG CAPSULE ORAL Rx AB 24MCG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8779187 | in 3 mo | Product | |
| 8338639 | in 3 mo | Product | |
| 8026393 | in 1 yr 1 mo | Product |
Approval history
FDA approval span
First approval
21 yr ago
Most recent approval
1 yr 10 mo ago
Approvals span 2006–2025 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Lubiprostone: 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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