FDA Orange Book · active-ingredient family
Droxidopa
Droxidopa: 1 brand, 16 generics; first approved Feb 18, 2014; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
16
Listed patents
0
Presentations
51
Brand (NDA) products
Originator applications
- NORTHERARLDLUNDBECK NA LTDNDA 20320220143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB
Generic (ANDA) products (16)
Abbreviated applications
- DROXIDOPACHARTWELL RXANDA 21421720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - DROXIDOPAADAPTISANDA 21526520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPAANNORAANDA 21172620213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - DROXIDOPASOMERSET THERAPS LLCANDA 21454320213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPABIONPHARMAANDA 21303320213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPAALKEM LABS LTDANDA 21391120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPAAUROBINDO PHARMA LTDANDA 21438720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPAHIKMAANDA 21283520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - DROXIDOPAJUBILANT CADISTAANDA 21439120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPALUPIN PHARMSANDA 21165220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - DROXIDOPAMSN PHARMS INCANDA 21174120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPASCIEGEN PHARMSANDA 21401720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPASUN PHARMANDA 21438420213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - DROXIDOPATEVA PHARMS USA INCANDA 21316220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - DROXIDOPAUPSHER SMITH LABSANDA 21366120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - DROXIDOPAZYDUS PHARMSANDA 21181820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
12 yr 8 mo ago
Most recent approval
4 yr 4 mo ago
Approvals span 2014–2022 across 17 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1694%
Droxidopa: 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.
