Viewing data from:

INBRIJA

NDA

LEVODOPA | N209184 | MERZ PHARMACEUTICALS LLC

1 strength6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Feb. 3, 2029

Nov. 16, 2032

Nov. 16, 2032

Nov. 16, 2032

Nov. 16, 2032

Oct. 21, 2033

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 Inbrija (2023)

Total Spending

$27.0M

Total Claims

8,730

Beneficiaries

2,486

Avg Cost/Unit

$19.62

Spending Trend

$11.7M(2019)→$20.4M(2020)→$25.2M(2021)→$23.1M(2022)→$27.0M(2023)

YoY Change:+10.5%

5yr CAGR:+4.7%

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

API Supply Chain11 active DMFs8 inactive

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

AJINOMOTO CO INCLEVODOPA

DMF 123791997

DIVIS LABORATORIES LTDLEVODOPA USP

DMF 178742004

SHANDONG XINHUA PHARMACEUTICAL CO LTDLEVODOPA

DMF 225982009

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTDLEVODOPA

DMF 279382014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVODOPA USP

DMF 316122017

AJINOMOTO CO INCLEVODOPA

DMF 316542017

ACELLA PHARMACEUTICALS LLCLEVODOPA

DMF 320572020

MAITHRI DRUGS PRIVATE LTDLEVODOPA USP

DMF 353122020

HETERO DRUGS LTDLEVODOPA

DMF 370472022

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDLEVODOPA

DMF 406082024

MIANYANG SHENGSHI HEALTH TECHNOLOGY CO LTDLEVODOPA

DMF 425012025

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveLEVODOPA (COMPOUND 7550)

DMF 13671969

KV PHARMACEUTICAL COInactiveLEVODOPA S.R.C. 300MG

DMF 23441974

HOFFMANN LA ROCHE INCInactiveLEVODOPA INJECTABLE

DMF 26641976

DAIICHI SANKYO CHEMICAL PHARMA CO LTDInactiveLEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT

DMF 50441983

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveLEVODOPA

DMF 84441989

EGIS PHARMACEUTICALS PRIVATE LTDInactiveLEVODOPA USP BULK

DMF 125051997

DELMAR CHEMICALS INCInactiveLEVODOPA METHYL ESTER HYDROCHLORIDE

DMF 205222007

TORRENT PHARMACEUTICALS LTDInactiveLEVODOPA

DMF 254982011

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 2, 2026	SUPPL -12	View Letter (PDF)
Sep 2, 2020	SUPPL -5	View Letter (PDF)
Sep 2, 2020	SUPPL -7	View Letter (PDF)
Aug 30, 2019	SUPPL -1	View Letter (PDF)
Dec 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 42MG

RLD

6 patents0 exclusivities▴

POWDER;INHALATION | Approved: Dec 21, 2018

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE43711	Feb 3, 2029	—	—	—		—
8545878	Nov 16, 2032	—	—	Yes	—	—
8685442	Nov 16, 2032	—	—	Yes	—	—
8945612	Nov 16, 2032	—	—	Yes	—	—
9393210	Nov 16, 2032	—	—	Yes	—	—
12458615	Oct 21, 2033	—	—	—		—