Viewing data from:

TARPEYO

NDA

BUDESONIDE | N215935 | CALLIDITAS THERAPEUTICS AB

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

May. 7, 2029

Jan. 23, 2043

Jan. 23, 2043

Jan. 23, 2043

Jan. 23, 2043

ODE-389

Dec. 15, 2028

ODE-464

Dec. 20, 2030

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

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
Calliditas Therapeutics AB v. Qilu Pharmaceutical Co., Ltd. et al 1:2026cv00197 4 patentsANDA 221134budesonide	D. Del.	2026-02-24	Active	—
Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al 1:2025cv00368 3 patentsANDA 218685budesonide	D. Del.	2025-03-25	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Tarpeyo (2023)

Total Spending

$16.0M

Total Claims

1,061

Beneficiaries

247

Avg Cost/Unit

$131.12

Spending Trend

$2.5M(2022)→$16.0M(2023)

YoY Change:+6.8%

5yr CAGR:+6.8%

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

API Supply Chain25 active DMFs4 inactive

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

ASPEN OSS BVBUDESONIDE

DMF 104931993

TAPI NL BVBUDESONIDE

DMF 109761994

TAPI NL BVBUDESONIDE

DMF 169322003

FARMABIOS SPABUDESONIDE

DMF 189102005

CURIA SPAIN SAUBUDESONIDE STERILE MICRONIZED

DMF 195282006

INDUSTRIALE CHIMICA SRLBUDESONIDE USP

DMF 200102006

AARTI PHARMALABS LTDBUDESONIDE USP

DMF 206092007

STERLING SPABUDESONIDE

DMF 226412009

NEWCHEM SPABUDESONIDE MICRONIZED

DMF 253192011

FARMABIOS SPABUDESONIDE MICRONIZED STERILE

DMF 256152011

CURIA SPAIN SAUBUDESONIDE MICRONIZED

DMF 256292011

SUN PHARMACEUTICAL INDUSTRIES LTDBUDESONIDE USP

DMF 264452013

APOTEX INCBUDESONIDE USP

DMF 274512013

CIPLA LTDBUDESONIDE USP

DMF 274612014

MINAKEMBUDESONIDE MICRONIZED

DMF 284412014

CORAL DRUGS PRIVATE LTDBUDESONIDE

DMF 305342017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBUDESONIDE USP BULK API

DMF 321952017

ASTRAZENECA PHARMACEUTICAL LPBUDESONIDE

DMF 331712018

AMPHASTAR NANJING PHARMACEUTICALS INCBUDESONIDE USP

DMF 337142019

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDBUDESONIDE

DMF 342682019

HENAN LIHUA PHARMACEUTICAL CO LTDBUDESONIDE

DMF 358592021

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND STERILE)

DMF 383732023

CHEMO IBERICA SABUDESONIDE MICRONIZED STERILE

DMF 395042024

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND NON-MICRONIZED)

DMF 396912024

AURISCO PHARMACEUTICAL CO LTDBUDESONIDE

DMF 412332025

FARMABIOS SRLInactiveBUDESONIDE

DMF 130131998

FARMABIOS SPAInactiveBUDESONIDE

DMF 152982001

ELAN PHARMACEUTICAL TECHNOLOGIESInactiveBUDESONIDE NANOCRISTAL COLLOIDAL DISPERSION

DMF 156622001

INDUSTRIALE CHIMICA SRLInactiveBUDESONIDE

DMF 158772002

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -5	View Letter (PDF)
Dec 22, 2023	SUPPL -3	View Letter (PDF)
Dec 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG

RLD

5 patents2 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Dec 15, 2021

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8491932	May 7, 2029	—	—	Yes		—
11896719	Jan 23, 2043	—	—	—		—
12171882	Jan 23, 2043	—	—	—		—
12171883	Jan 23, 2043	—	—	Yes	—	—
12311057	Jan 23, 2043	—	—	Yes		—

Exclusivities (2)

Code	Date	Status
ODE-389	Dec 15, 2028	Active
ODE-464	Dec 20, 2030	Active