Viewing data from:

TALICIA

NDA

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN | N213004 | TALICIA HOLDINGS INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Feb. 12, 2034

Feb. 12, 2034

Feb. 12, 2034

Feb. 12, 2034

Feb. 12, 2034

May. 27, 2042

Feb. 12, 2034

Nov. 1, 2022

GAIN

Nov. 1, 2027

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 Talicia (2023)

Total Spending

$3.3M

Total Claims

4,147

Beneficiaries

4,049

Avg Cost/Unit

$4.78

Spending Trend

$760K(2020)→$2.3M(2021)→$3.1M(2022)→$3.3M(2023)

YoY Change:+8.5%

5yr CAGR:+6.4%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 2, 2024	SUPPL -14	View Letter (PDF)
Sep 11, 2023	SUPPL -10	View Letter (PDF)
Jul 19, 2023	SUPPL -12	View Letter (PDF)
Mar 7, 2022	SUPPL -7	View Letter (PDF)
Oct 5, 2021	SUPPL -4	View Letter (PDF)
Dec 1, 2020	SUPPL -2	View Letter (PDF)
Nov 7, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG;EQ 10MG BASE;12.5MG

RLD

7 patents2 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Nov 1, 2019

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9050263	Feb 12, 2034	—	—	Yes		—
9498445	Feb 12, 2034	—	—	Yes		—
9603806	Feb 12, 2034	—	—	Yes		—
10238606	Feb 12, 2034	—	—	Yes	—	—
11135172	Feb 12, 2034	—	—	Yes		—
11878011	May 27, 2042	—	—	—		—
11931463	Feb 12, 2034	—	—	Yes		—

Exclusivities (2)

Code	Date	Status
GAIN	Nov 1, 2027	Active
NP	Nov 1, 2022	Expired