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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

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Aether Therapeutics Inc. v. AstraZeneca AB et al 1:2020cv00381	D. Del.	2020-03-18	Terminated 2023-04-06	—
AstraZeneca AB et al v. Aurobindo Pharma USA Inc. 1:2019cv02113	D. Del.	2019-11-08	Terminated 2021-09-22	—
AstraZeneca AB et al v. MSN Pharmaceuticals, Inc. et al 1:2018cv02051	D. Del.	2018-12-26	Terminated 2021-03-25	—
AstraZeneca AB et al v. Apotex Inc. et al 1:2018cv02010	D. Del.	2018-12-18	Terminated 2021-07-22	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$14.61

per ea

Lowest NADAC/Unit

$14.61

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82625880201MOVANTIK 25 MG TABLET	$14.61	EA	Brand	—	2026-06-17
82625880203MOVANTIK 25 MG TABLET	$14.61	EA	Brand	—	2026-06-17
57841130101MOVANTIK 25 MG TABLET	$14.61	EA	Brand	—	2026-06-17
57841130103MOVANTIK 25 MG TABLET	$14.61	EA	Brand	—	2026-06-17
82625880101MOVANTIK 12.5 MG TABLET	$14.61	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 | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$314.37

Highest Price

$1381.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82625-8801-01MOVANTIK 12.5MG TAB	$414.46	FSS	Averitas Pharma, Inc.	09/28/2030
82625-8801-01MOVANTIK 12.5MG TAB	$314.39	Big4	Averitas Pharma, Inc.	09/28/2030
82625-8802-01MOVANTIK 25MG TAB	$414.46	FSS	Averitas Pharma, Inc.	09/28/2030
82625-8802-01MOVANTIK 25MG TAB	$314.37	Big4	Averitas Pharma, Inc.	09/28/2030
82625-8802-03MOVANTIK 25MG TAB	$1381.57	FSS	Averitas Pharma, Inc.	09/28/2030
82625-8802-03MOVANTIK 25MG TAB	$1048.16	Big4	Averitas Pharma, Inc.	09/28/2030

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

Medicare Part D Spending

CMS annual spending data for Movantik (2024)

Total Spending

$153.3M

Total Claims

336,315

Beneficiaries

80,688

Avg Cost/Unit

$13.50

Spending Trend

$12.4M(2020)→$93.5M(2021)→$121.4M(2022)→$140.6M(2023)→$153.3M(2024)

YoY Change:-3.0%

5yr CAGR:+2.7%

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