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MAVYRET

NDA

GLECAPREVIR; PIBRENTASVIR | N209394 | ABBVIE INC

1 strength10 unique patents6 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

Dec. 10, 2028

ODE-233

Dec. 10, 2028

I-967

Dec. 10, 2028

ODE-372

Dec. 10, 2028

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

16 trials from ClinicalTrials.gov — 1 recruiting, 12 completed

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 → 2028-03-03
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment NCT03069365	Phase 3	Completed	AbbVie	101	2017-03-28 → 2018-06-05
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection NCT04042740	Phase 2	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	45	2019-11-20 → 2023-08-22
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection NCT02966795	Phase 3	Completed	AbbVie	84	2017-01-25 → 2018-08-29
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)NCT02692703	Phase 3	Completed	AbbVie	100	2016-04-22 → 2017-06-29
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1 NCT03212521	Phase 3	Completed	AbbVie	230	2017-08-07 → 2018-08-13
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection NCT03235349	Phase 3	Completed	AbbVie	160	2017-09-29 → 2019-02-25
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection NCT03067129	Phase 2/3	Completed	AbbVie	129	2017-03-20 → 2022-09-12
Multi-center Study to Transplant Hepatitis-C Infected Kidneys NCT03781726	Phase 4	Completed	Raymond Chung	30	2019-04-10 → 2021-12-31
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection NCT03222583	Phase 3	Completed	AbbVie	546	2017-10-04 → 2019-02-15

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$152.89

per ea

Lowest NADAC/Unit

$152.89

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00074262584MAVYRET 100-40 MG TABLET	$152.89	EA	Brand	—	2026-10-21
00074262504MAVYRET 100-40 MG TABLET	$152.89	EA	Brand	—	2026-10-21
00074262528MAVYRET 100-40 MG TABLET	$152.89	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$7242.22

Highest Price

$9684.42

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-2625-04MAVYRET 100MG-40MG, TABLET	$9329.46	Big4	Abbvie US LLC	07/31/2030
00074-2625-04MAVYRET 100MG-40MG, TABLET	$9684.42	FSS	Abbvie US LLC	07/31/2030
00074-2625-28MAVYRET 100MG-40MG, TABLET	$9329.46	Big4	Abbvie US LLC	07/31/2030
00074-2625-28MAVYRET 100MG-40MG, TABLET	$9684.42	FSS	Abbvie US LLC	07/31/2030
00074-2625-84MAVYRET 100MG-40MG, TABLET	$7242.22	Big4	Abbvie US LLC	07/31/2030
00074-2625-84MAVYRET 100MG-40MG, TABLET	$9684.42	FSS	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Mavyret (2024)

Total Spending

$165.3M

Total Claims

12,457

Beneficiaries

6,721

Avg Cost/Unit

$155.84

Spending Trend

$538.9M(2019)→$295.8M(2020)→$259.7M(2021)→$235.1M(2022)→$233.0M(2023)→$165.3M(2024)

YoY Change:-6.3%

5yr CAGR:-0.9%

Source: CMS Medicare Part D Spending by Drug (2024). 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

20 patents6 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 2017

Patents (20)

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		—
8648037	Jan 19, 2032PED: Jul 19, 2032	PED	Yes	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	—	—		—
9586978	Nov 6, 2030PED: May 6, 2031	PED	—	—		—
9586978	Nov 6, 2030PED: May 6, 2031	PED	—	—		—
10028937	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10028937	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10028937	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10039754	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10039754	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10039754	Jun 10, 2030PED: Dec 10, 2030	PED	—	—		—
10286029	Mar 14, 2034PED: Sep 14, 2034	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	—	—		—
11484534	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—

Exclusivities (6)

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	Dec 10, 2028	Active
PED	Oct 30, 2026	Expired