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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
IPR2018-00943	7919499	IPR	Amneal Pharmaceuticals LLC	Terminated-Settled	2018-04-20	—
IPR2025-00514	7919499	IPR	Apotex Inc. et al.	Discretionary Denial	2025-01-30	2025-07-02

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/019,779Ex PartePending

Patent: 7919499Filed: 2024-12-16

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vivitrol (2023)

Total Spending

$62.2M

Total Claims

37,159

Beneficiaries

8,594

Avg Cost/Unit

$1669.62

Spending Trend

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

YoY Change:+8.0%

5yr CAGR:+5.7%

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

Medicare Part B Spending

CMS physician-administered drug spending for Vivitrol (2023)

Total Spending

$2.3M

Total Claims

1,999

Beneficiaries

546

ASP Price

—

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

Source: CMS Medicare Part B Spending by Drug (2023). 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)

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