FDA Orange Book · active-ingredient family
Isotretinoin
Isotretinoin: 3 brands, 16 generics; first approved May 07, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
2
Next patent expiry
May 29, 2035
in 8 yr 10 mo
Brand (NDA) products
Originator applications
- ABSORICA LDRLDSUN PHARMNDA 21191320196 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG CAPSULE ORAL Rx — 16MG CAPSULE ORAL Rx — 20MG CAPSULE ORAL Discontinued — 24MG CAPSULE ORAL Rx — 28MG CAPSULE ORAL Discontinued — 32MG CAPSULE ORAL Rx — - ABSORICARLDSUN PHARM INDS INCNDA 02195120126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB2 20MG CAPSULE ORAL Rx AB2 30MG CAPSULE ORAL Rx AB2 40MG CAPSULE ORAL Rx AB2 25MG CAPSULE ORAL Rx AB2 35MG CAPSULE ORAL Rx AB2 - ACCUTANERLDHOFFMANN LA ROCHENDA 01866219823 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 40MG CAPSULE ORAL Discontinued — 20MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- ISOTRETINOINAUROBINDO PHARMA LTDANDA 22033620263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 - ISOTRETINOINAMNEAL PHARMS NYANDA 21609720256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 20MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — 30MG CAPSULE ORAL Discontinued — 35MG CAPSULE ORAL Discontinued — 40MG CAPSULE ORAL Discontinued — - ISOTRETINOINZYDUS PHARMSANDA 21663320256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB2 20MG CAPSULE ORAL Rx AB2 25MG CAPSULE ORAL Rx AB2 30MG CAPSULE ORAL Rx AB2 35MG CAPSULE ORAL Rx AB2 40MG CAPSULE ORAL Rx AB2 - ISOTRETINOINAUROBINDO PHARMAANDA 21819420246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB2 20MG CAPSULE ORAL Rx AB2 25MG CAPSULE ORAL Rx AB2 30MG CAPSULE ORAL Rx AB2 35MG CAPSULE ORAL Rx AB2 40MG CAPSULE ORAL Rx AB2 - ISOTRETINOINZYDUS PHARMSANDA 21156820234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 - ISOTRETINOINUPSHER SMITH LABSANDA 21233320213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB2 20MG CAPSULE ORAL Rx AB2 30MG CAPSULE ORAL Rx AB2 - ISOTRETINOINUPSHER SMITH LABSANDA 2135712021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE ORAL Rx AB2 - ISOTRETINOINACTAVIS LABS FLANDA 20506320216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB2 20MG CAPSULE ORAL Rx AB2 25MG CAPSULE ORAL Rx AB2 30MG CAPSULE ORAL Rx AB2 35MG CAPSULE ORAL Rx AB2 40MG CAPSULE ORAL Rx AB2 - ISOTRETINOINAMNEAL PHARMS NYANDA 20779220174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 - DR REDDYS LABS LTDANDA 20209920134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 - UPSHER SMITH LABSANDA 07648520124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 - SUN PHARM INDS LTDANDA 0765032003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Discontinued — - TEVA PHARMS USAANDA 0763562003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 - TEVA PHARMS USAANDA 07613520033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1 - SUN PHARM INDS LTDANDA 07604120023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 20MG CAPSULE ORAL Discontinued — 40MG CAPSULE ORAL Discontinued — - MYLAN PHARMS INCANDA 07594520024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB1 20MG CAPSULE ORAL Rx AB1 40MG CAPSULE ORAL Rx AB1 30MG CAPSULE ORAL Rx AB1
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9750711 | in 8 yr 10 mo | Product | |
| 9700535 | in 9 yr | Product |
Approval history
FDA approval span
First approval
45 yr ago
Most recent approval
12 d ago
Approvals span 1982–2026 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Isotretinoin: 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
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- 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.
