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MOVANTIK

NDA

NALOXEGOL OXALATE | N204760 | AVERITAS PHARMA INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

Today

7786133

Sep. 16, 2028IPR

9012469

Apr. 2, 2032

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00049	7786133	IPR	Neptune Generics, LLC	Institution Denied	2015-10-15	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Movantik (2023)

Total Spending

$140.6M

Total Claims

297,091

Beneficiaries

73,045

Avg Cost/Unit

$13.91

Spending Trend

$12.4M(2020)→$93.5M(2021)→$121.4M(2022)→$140.6M(2023)

YoY Change:+3.0%

5yr CAGR:+4.7%

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

API Supply Chain3 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LIFE SCIENCES PRIVATE LTDNALOXEGOL OXALATE

DMF 325352018

MSN LIFE SCIENCES PRIVATE LTDNALOXEGOL OXALATE (PREMIX)

DMF 325622018

APITORIA PHARMA PRIVATE LTDNALOXEGOL OXALATE PREMIX

DMF 334052018

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Apr 15, 2020	SUPPL -9	View Letter (PDF)
Jun 4, 2019	SUPPL -8	View Letter (PDF)
Mar 1, 2018	SUPPL -7	View Letter (PDF)
Aug 2, 2017	SUPPL -5	View Letter (PDF)
Aug 22, 2016	SUPPL -2	View Letter (PDF)
Aug 22, 2016	SUPPL -3	View Letter (PDF)
Jul 26, 2016	SUPPL -1	View Letter (PDF)
Sep 17, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 12.5MG BASE

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 16, 2014

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7786133	Sep 16, 2028	—	Yes	Yes	—	—
9012469	Apr 2, 2032	—	Yes	Yes	—	—

#002 — EQ 25MG BASE

RLD

2 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 16, 2014