FDA Orange Book · active-ingredient family
Levonorgestrel
Levonorgestrel is approved as 10 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KYLEENA · NDA 208224
10
Brand (NDA)
21
Generics (ANDA)
7
Listed patents
1
Exclusivity periods
Brand (NDA) products · implant, system, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KYLEENARLD | BAYER HLTHCARE | NDA 208224 | — | Sep 16, 2016 | |
| LILETTARLD | MEDICINES360 | NDA 206229 | — | Feb 26, 2015 | |
| SKYLARLD | BAYER HLTHCARE | NDA 203159 | — | Jan 09, 2013 | |
| PLAN B ONE-STEPRLD | FDN CONSUMER | NDA 021998 | — | Jul 10, 2009 | |
| MIRENARLD | BAYER HLTHCARE | NDA 021225 | — | Dec 06, 2000 | |
| PLAN BRLD×2 | FDN CONSUMER | NDA 021045 | — | Jul 28, 1999 | |
| JADELLERLD | POPULATION COUNCIL | NDA 020544 | — | Nov 01, 1996 | |
| LEVONORGESTREL | WYETH PHARMS INC | NDA 020627 | — | Aug 15, 1996 | |
| NORPLANT | POPULATION COUNCIL | NDA 019897 | — | Dec 10, 1990 | |
| NORPLANT SYSTEM IN PLASTIC CONTAINER | WYETH PHARMS INC | NDA 020088 | — | Dec 10, 1990 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVONORGESTREL | ANNORA PHARMA | ANDA 219102 | — | Sep 30, 2025 | |
| LEVONORGESTREL | NAARI PTE | ANDA 207660 | — | May 02, 2019 | |
| LEVONORGESTREL | XIROMED | ANDA 205329 | — | Sep 18, 2018 | |
| LEVONORGESTREL | LABORATOIRE HRA | ANDA 204044 | — | Jul 03, 2018 | |
| LEVONORGESTREL | LOTUS PHARM CO LTD | ANDA 202684 | — | Sep 02, 2016 | |
| LEVONORGESTREL | XIROMED | ANDA 202740 | — | Sep 02, 2016 | |
| LEVONORGESTREL | GLENMARK PHARMS LTD | ANDA 207044 | — | Mar 25, 2016 | |
| HER STYLE | NOVAST LABS | ANDA 207976 | — | Mar 11, 2016 | |
| ATHENTIA NEXT | AUROBINDO PHARMA | ANDA 206867 | — | Dec 08, 2015 | |
| LEVONORGESTREL | ALVOGEN | ANDA 202246 | — | Jun 05, 2015 | |
| LEVONORGESTREL | NAARI PTE | ANDA 202380 | — | May 29, 2015 | |
| LEVONORGESTREL | XIROMED | ANDA 202739 | — | Oct 31, 2014 | |
| OPCICON ONE-STEP | SUN PHARM | ANDA 202635 | — | Sep 11, 2014 | |
| LEVONORGESTREL | PERRIGO R AND D | ANDA 202334 | — | Aug 20, 2014 | |
| FALLBACK SOLO | LUPIN | ANDA 201446 | — | Jun 19, 2014 | |
| LEVONORGESTREL | NOVEL LABS INC | ANDA 202508 | — | Feb 22, 2013 | |
| LEVONORGESTREL | LUPIN LTD | ANDA 091328 | — | Jan 23, 2013 | |
| LEVONORGESTREL | FDN CONSUMER | ANDA 200670 | — | Jul 12, 2012 | |
| LEVONORGESTREL | L PERRIGO CO | ANDA 090740 | — | Dec 30, 2010 | |
| LEVONORGESTREL | FDN CONSUMER | ANDA 078665 | — | Aug 28, 2009 | |
| LEVONORGESTREL | WATSON LABS | ANDA 078666 | — | Jun 24, 2009 |
Marketing exclusivity (1)
- I-917New indication exclusivity (3 years)
Jun 29, 2026
in 10 d
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11628088 | Feb 07, 2027 | in 8 mo | Product |
| 11850182 | Sep 14, 2029 | in 3 yr 3 mo | ProductU-3819 |
| 10561524 | Sep 16, 2029 | in 3 yr 4 mo | U-2948 |
| 12004992 | Oct 06, 2033 | in 7 yr 5 mo | Substance |
| 11090186 | Oct 24, 2033 | in 7 yr 5 mo | U-2348 |
| 10028858 | Mar 22, 2034 | in 7 yr 10 mo | ProductU-2348 |
| 11571328 | Sep 07, 2040 | in 14 yr 5 mo | Product |
Levonorgestrel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
