Viewing data from:

KYLEENA

NDA

LEVONORGESTREL | N208224 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (1)Active (2)Today

2027

2028

2029

Today

10561524

Sep. 16, 2029

11628088

Feb. 7, 2027

11850182

Sep. 14, 2029

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 Kyleena (2023)

Total Spending

$49K

Total Claims

Beneficiaries

Avg Cost/Unit

$1164.52

Spending Trend

$46K(2019)→$45K(2020)→$38K(2021)→$40K(2022)→$49K(2023)

YoY Change:+4.2%

5yr CAGR:+4.4%

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

5 letters from Drugs@FDA

Date	Submission	Document
May 5, 2023	SUPPL -5	View Letter (PDF)
Jan 11, 2022	SUPPL -4	View Letter (PDF)
Apr 27, 2021	SUPPL -2	View Letter (PDF)
Mar 5, 2018	SUPPL -1	View Letter (PDF)
Sep 20, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 19.5MG

RLD

3 patents0 exclusivities▴

SYSTEM;INTRAUTERINE | Approved: Sep 16, 2016

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10561524	Sep 16, 2029	—	—	—		—
11628088	Feb 7, 2027	—	—	Yes	—	—
11850182	Sep 14, 2029	—	—	Yes		—