Viewing data from:

VIVITROL

NDA

NALTREXONE | N021897 | ALKERMES INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

2027

2028

2029

Today

7919499

Oct. 15, 2029IPR×2

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2025-00514	7919499	IPR	Apotex Inc. et al.	Discretionary Denial	2025-01-30	2025-07-02
IPR2018-00943	7919499	IPR	Amneal Pharmaceuticals LLC	Terminated-Settled	2018-04-20	—

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/019,779Ex ParteCertificate Issued

Patent: 7919499Filed: 2024-12-16Certificate: 2025-10-15

NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE

Recent Events

2025-08-19RXLITSRLitigation Search Conducted

2025-01-13RXRLFLitigation Found

2025-01-13RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALKERMES, INC. et al v. TEVA PHARMACEUTICAL INDUSTRIES USA,INC 2:2020cv12470 1 patentANDA 213195naltrexone	D.N.J.	2020-09-09	Terminated 2023-08-30	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

282 trials from ClinicalTrials.gov — 1 recruiting, 239 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Opioids and Social Support Enhanced Extinction Effects NCT04166071	Early Phase 1	By Invitation	University of California, Los Angeles	60	2021-12-13 → 2026-09
Naltrexone for Early Problem Drinkers NCT00000455	Phase 4	Completed	UConn Health	160	— → 2002-09
The Effect of Regular Naltrexone Dosing on Disordered Gamblers NCT02537197	Phase 1	Completed	University of Calgary	35	2016-04 → 2022-05-26
Double-Blind Naltrexone in Kleptomania NCT00332579	Phase 2	Completed	University of Minnesota	25	2006-05-01 → 2008-09-01
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment NCT00938886	Phase 2	Completed	Brown University	150	2009-10 → 2015-12
Medication-Assisted Treatment for Youth With Substance Use Disorders NCT02593474	Phase 1	Completed	New York State Psychiatric Institute	11	2015-09 → 2018-04
Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)NCT00453609	Phase 4	Completed	State University of New York - Upstate Medical University	15	2007-04 → 2008-10
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention NCT01528007	Phase 4	Completed	Finnish Institute for Health and Welfare	100	2011-01 → 2013-09
Biomarkers of Injectable Extended Release Naltrexone Treatment NCT02324725	Phase 4	Completed	University of Pennsylvania	32	2011-10 → 2021-12
Trial of Naltrexone and Dextromethorphan for Gulf War Illness NCT02206490	Phase 2	Completed	East Carolina University	60	2012-01 → 2016-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1717.19

per ea

Lowest NADAC/Unit

$1717.19

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65757030001VIVITROL 380 MG VIAL-DILUENT	$1717.19	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1156.61

Highest Price

$1510.31

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
65757-0300-01VIVITROL 380MG/VIL INJ,SUSP,SA	$1510.31	FSS	Alkermes, Inc.	07/31/2026
65757-0300-01VIVITROL 380MG/VIL INJ,SUSP,SA	$1156.61	Big4	Alkermes, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Vivitrol (2024)

Total Spending

$73.1M

Total Claims

44,521

Beneficiaries

9,867

Avg Cost/Unit

$1621.97

Spending Trend

$36.0M(2019)→$36.7M(2020)→$43.3M(2021)→$50.7M(2022)→$62.2M(2023)→$73.1M(2024)

YoY Change:-2.9%

5yr CAGR:+4.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Vivitrol (2024)

Total Spending

$2.6M

Total Claims

2,228

Beneficiaries

601

ASP Price

$4.03

Spending Trend

$1.6M(2019)→$1.7M(2020)→$2.1M(2021)→$2.5M(2022)→$2.3M(2023)→$2.6M(2024)

YoY Change:+2.8%

5yr CAGR:+5.9%

HCPCS: J2315 — Injection, naltrexone, depot form, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain6 active DMFs5 inactive

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

SPECGX LLCNALTREXONE HCL

DMF 62651986

SPECGX LLCNALTREXONE BASE

DMF 95721992

NORAMCO LLCNALTREXONE DRUG SUBSTANCE

DMF 229922009

CHONGQING LAND TOWER PHARMACEUTICAL CO LTDNALTREXONE

DMF 296192015

SANECA PHARMACEUTICALS ASNALTREXONE

DMF 316912017

SIEGFRIED AGNALTREXONE

DMF 404142024

MALLINCKRODT CHEMICAL INCInactiveNALTREXONE METHOBROMIDE

DMF 89481991

TASMANIAN ALKALOIDS PTY LTDInactiveNALTREXONE BENZOATE

DMF 123491997

DIOSYNTH BVInactiveNALTREXONE

DMF 152212001

SPECGX LLCInactiveNALTREXONE METHOBROMIDE

DMF 158372002

NV ORGANONInactiveNALTREXONE

DMF 175632004

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -61	View Letter (PDF)
May 10, 2021	SUPPL -55	View Letter (PDF)
Mar 5, 2021	SUPPL -52	View Letter (PDF)
May 11, 2020	SUPPL -49	View Letter (PDF)
Sep 9, 2019	SUPPL -45	View Letter (PDF)
Dec 30, 2018	SUPPL -42	View Letter (PDF)
May 19, 2016	SUPPL -32	View Letter (PDF)
Dec 29, 2015	SUPPL -29	View Letter (PDF)
Jul 31, 2013	SUPPL -20	View Letter (PDF)
Jul 31, 2013	SUPPL -23	View Letter (PDF)
Oct 13, 2010	SUPPL -15	View Letter (PDF)
Mar 25, 2010	SUPPL -10	View Letter (PDF)
Mar 25, 2010	SUPPL -5	View Letter (PDF)
Nov 8, 2007	SUPPL -3	View Letter (PDF)
Apr 21, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 380MG/VIAL

RLD

1 patent0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Apr 13, 2006

Patents (1) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7919499	Oct 15, 2029	—	—	—		—