FDA Orange Book · active-ingredient family
Levonorgestrel
Levonorgestrel: 10 brands, 21 generics; first approved Dec 10, 1990; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
10
Generics (ANDA)
21
Listed patents
7
Next patent expiry
Feb 07, 2027
in 4 mo
Brand (NDA) products
Originator applications
- BAYER HLTHCARENDA 2082242016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 19.5MG SYSTEM INTRAUTERINE Rx — - MEDICINES360NDA 2062292015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 52MG SYSTEM INTRAUTERINE Rx — - BAYER HLTHCARENDA 2031592013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 13.5MG SYSTEM INTRAUTERINE Rx — - FDN CONSUMERNDA 0219982009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - BAYER HLTHCARENDA 0212252000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 52MG SYSTEM INTRAUTERINE Rx — - PLAN BRLDFDN CONSUMERNDA 02104519992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — 0.75MG TABLET ORAL Discontinued — - JADELLERLDPOPULATION COUNCILNDA 0205441996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/IMPLANT IMPLANT IMPLANTATION Discontinued — - LEVONORGESTRELWYETH PHARMS INCNDA 0206271996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/IMPLANT IMPLANT IMPLANTATION Discontinued — - POPULATION COUNCILNDA 0198971990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 36MG/IMPLANT IMPLANT IMPLANTATION Discontinued — - WYETH PHARMS INCNDA 0200881990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 36MG/IMPLANT IMPLANT IMPLANTATION Discontinued —
Generic (ANDA) products (21)
Abbreviated applications
- LEVONORGESTRELANNORA PHARMAANDA 2191022025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELNAARI PTEANDA 2076602019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELXIROMEDANDA 2053292018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELLABORATOIRE HRAANDA 2040442018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELLOTUS PHARM CO LTDANDA 2026842016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - LEVONORGESTRELXIROMEDANDA 2027402016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - LEVONORGESTRELGLENMARK PHARMS LTDANDA 2070442016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - NOVAST LABSANDA 2079762016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - AUROBINDO PHARMAANDA 2068672015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELALVOGENANDA 2022462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Discontinued — - LEVONORGESTRELNAARI PTEANDA 2023802015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELXIROMEDANDA 2027392014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - SUN PHARMANDA 2026352014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELPERRIGO R AND DANDA 2023342014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LUPINANDA 2014462014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELNOVEL LABS INCANDA 2025082013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL OTC — - LEVONORGESTRELLUPIN LTDANDA 0913282013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - LEVONORGESTRELFDN CONSUMERANDA 2006702012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Discontinued — - LEVONORGESTRELL PERRIGO COANDA 0907402010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - LEVONORGESTRELFDN CONSUMERANDA 0786652009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - LEVONORGESTRELWATSON LABSANDA 0786662009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-917New indication exclusivity (3 years)
3 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11628088 | in 4 mo | Product | |
| 11850182 | in 3 yr | ProductU-3819 | |
| 10561524 | in 3 yr | U-2948 | |
| 12004992 | in 7 yr 1 mo | Substance | |
| 11090186 | in 7 yr 2 mo | U-2348 | |
| 10028858 | in 7 yr 7 mo | ProductU-2348 | |
| 11571328 | in 14 yr 1 mo | Product |
Approval history
FDA approval span
First approval
36 yr 4 mo ago
Most recent approval
1 yr ago
Approvals span 1990–2025 across 31 FDA applications.
Brand (NDA) 1032%
Generic (ANDA) 2168%
Levonorgestrel: 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.
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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.
