Viewing data from:

LILETTA

NDA

LEVONORGESTREL | N206229 | MEDICINES360

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Mar. 22, 2034

Oct. 24, 2033

Sep. 7, 2040

Oct. 6, 2033

I-917

Jun. 29, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Liletta (2023)

Total Spending

$28K

Total Claims

Beneficiaries

Avg Cost/Unit

$871.21

Spending Trend

$15K(2019)→$13K(2020)→$33K(2021)→$24K(2022)→$28K(2023)

YoY Change:-1.3%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs7 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGLEVONORGESTREL

DMF 41781981

INDUSTRIALE CHIMICA SRLLEVONORGESTREL USP

DMF 166962003

SCINOPHARM TAIWAN LTDLEVONORGESTREL USP

DMF 170672003

CIPLA LTDLEVONORGESTREL USP

DMF 215472008

FORMOSA LABORATORIES INCLEVONORGESTREL

DMF 216342008

LUPIN LTDLEVONORGESTREL USP

DMF 225082009

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTDLEVONORGESTREL (MICRONIZED)

DMF 276922013

SYMBIOTEC PHARMALAB PRIVATE LTDLEVONORGESTREL EP/USP, MICRONIZED

DMF 278672014

STERLING CHEMICAL MALTA LTDLEVONORGESTREL

DMF 285022014

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 330002022

HUNAN KYF PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 374432022

VALARY LAB PRIVATE LTDLEVONORGESTREL

DMF 421412025

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 428742025

BIOTEK INCInactiveLEVONORGESTREL MICROCAPSULES

DMF 51561983

LEIRAS PHARMACEUTICALSInactiveLEVONORGESTREL INTRAUTERINE DEVICE

DMF 61751986

BIOTEK INCInactiveLEVONORGESTREL MICROCAPSULES

DMF 62251986

YANGZHOU PHARMACEUTICAL FACTORYInactiveLEVONORGESTREL USP 23

DMF 129341998

HOECHST MARION ROUSSELInactiveLEVONORGESTREL

DMF 142881999

BAYER PHARMA AGInactiveLEVONORGESTREL (DCM)

DMF 184032005

INDO PHYTO CHEMICALS PRIVATE LTDInactiveLEVONORGESTREL USP

DMF 260642012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2024	ORIG -1	View Letter (PDF)
Jun 30, 2023	SUPPL -13	View Letter (PDF)
Nov 14, 2022	SUPPL -11	View Letter (PDF)
Nov 14, 2022	SUPPL -12	View Letter (PDF)
Apr 29, 2020	SUPPL -10	View Letter (PDF)
Oct 29, 2019	SUPPL -8	View Letter (PDF)
Oct 17, 2018	SUPPL -7	View Letter (PDF)
Aug 7, 2017	SUPPL -4	View Letter (PDF)
Feb 1, 2016	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 52MG

RLD

4 patents1 exclusivity▴

SYSTEM;INTRAUTERINE | Approved: Feb 26, 2015

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10028858	Mar 22, 2034	—	—	Yes		—
11090186	Oct 24, 2033	—	—	—		—
11571328	Sep 7, 2040	—	—	Yes	—	—
12004992	Oct 6, 2033	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
I-917	Jun 29, 2026	Expired