FDA Orange Book · active-ingredient family
Darunavir
Darunavir: 2 brands, 11 generics; first approved Jun 23, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
11
Listed patents
2
Next patent expiry
Dec 26, 2026
in 5 mo
Brand (NDA) products
Originator applications
- JANSSEN PRODSNDA 2028952011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SUSPENSION ORAL Rx — - PREZISTARLDJANSSEN PRODSNDA 02197620086 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — 600MG TABLET ORAL Rx AB 400MG TABLET ORAL Discontinued — 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB
Generic (ANDA) products (11)
Abbreviated applications
- DARUNAVIRMYLANANDA 20213620255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx — 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB - DARUNAVIRANNORA PHARMAANDA 21616820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRZYDUS LIFESCIENCESANDA 21408520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRAMNEALANDA 21249320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRAUROBINDO PHARMA LTDANDA 21067720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRCIPLAANDA 20628820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRDR REDDYSANDA 21157820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRMSNANDA 21538920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRHETERO LABS LTD IIIANDA 20208320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB - DARUNAVIRLUPINANDA 20207320222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - DARUNAVIRTEVA PHARMS USAANDA 2021182017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700645 | in 5 mo | SubstanceProduct | |
| 7700645*PED | in 11 mo |
Approval history
FDA approval span
First approval
20 yr 5 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 2006–2025 across 13 FDA applications.
Brand (NDA) 215%
Generic (ANDA) 1185%
Darunavir: 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.
