Viewing data from:

MAVYRET

NDA

GLECAPREVIR; PIBRENTASVIR | N209394 | ABBVIE INC

1 strength10 unique patents5 unique exclusivities

Patent Timeline

10 unique patents, 4 exclusivities by expiration date

Active (10)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Nov. 8, 2035

Jul. 19, 2032

Nov. 18, 2032

Dec. 5, 2035

May. 6, 2031

Dec. 10, 2030

Dec. 10, 2030

Sep. 14, 2034

Dec. 24, 2036

Sep. 14, 2034

ODE-232

Oct. 30, 2026

ODE-233

Oct. 30, 2026

I-967

Oct. 30, 2026

ODE-372

Oct. 30, 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV NCT07040319	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	30	2026-06-25 → 2027-10-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Mavyret (2023)

Total Spending

$233.0M

Total Claims

16,579

Beneficiaries

8,771

Avg Cost/Unit

$166.23

Spending Trend

$538.9M(2019)→$295.8M(2020)→$259.7M(2021)→$235.1M(2022)→$233.0M(2023)

YoY Change:+0.8%

5yr CAGR:+0.7%

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Apr 7, 2026	SUPPL -18	View Letter (PDF)
Jun 12, 2025	SUPPL -19	View Letter (PDF)
Oct 26, 2023	SUPPL -16	View Letter (PDF)
Sep 29, 2021	SUPPL -14	View Letter (PDF)
Jun 14, 2021	SUPPL -13	View Letter (PDF)
Apr 13, 2020	SUPPL -10	View Letter (PDF)
Sep 27, 2019	SUPPL -7	View Letter (PDF)
Sep 27, 2019	SUPPL -8	View Letter (PDF)
Apr 30, 2019	SUPPL -6	View Letter (PDF)
Aug 7, 2018	SUPPL -2	View Letter (PDF)
Dec 18, 2017	SUPPL -3	View Letter (PDF)
Aug 7, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG;40MG

RLD

10 patents5 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 2017

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE48923	May 8, 2035PED: Nov 8, 2035	PED	Yes	—	—	—
8648037	Jan 19, 2032PED: Jul 19, 2032	PED	Yes	Yes		—
8937150	May 18, 2032PED: Nov 18, 2032	PED	Yes	Yes	—	—
9321807	Jun 5, 2035PED: Dec 5, 2035	PED	Yes	—	—	—
9586978	Nov 6, 2030PED: May 6, 2031	PED	—	—		—
10028937	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10039754	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10286029	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—
11246866	Jun 24, 2036PED: Dec 24, 2036	PED	—	Yes	—	—
11484534	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—

Exclusivities (5)

Code	Date	Status
I-967	Jun 10, 2028	Active
ODE-232	Apr 30, 2026	Expired
ODE-233	Apr 30, 2026	Expired
ODE-372	Jun 10, 2028	Active
PED	Oct 30, 2026	< 1 year