Naloxegol oxalate - Generic Drug Details

What are the generic drug sources for naloxegol oxalate and what is the scope of freedom to operate?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Valinor and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has one hundred and sixteen patent family members in forty-four countries.

There are three drug master file entries for naloxegol oxalate. Three suppliers are listed for this compound.

Summary for naloxegol oxalate

International Patents:	116
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxegol oxalate
What excipients (inactive ingredients) are in naloxegol oxalate?	naloxegol oxalate excipients list
DailyMed Link:	naloxegol oxalate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for naloxegol oxalate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for naloxegol oxalate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut Paoli-Calmettes	Phase 2

See all naloxegol oxalate clinical trials

Pharmacology for naloxegol oxalate

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for naloxegol oxalate

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVANTIK	Tablets	naloxegol oxalate	12.5 mg and 25 mg	204760	2	2018-09-17

US Patents and Regulatory Information for naloxegol oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y

Expired US Patents for naloxegol oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014

International Patents for naloxegol oxalate

Country	Patent Number	Title	Estimated Expiration
Ukraine	112847	ОКСАЛАТНА СІЛЬ КОН'ЮГАТА mPEG7-O-НАЛОКСОЛУ (ВАРІАНТИ), СПОСІБ ЇЇ ОТРИМАННЯ (ВАРІАНТИ) ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ
Spain	2654819
Hungary	S1500026
Spain	2817799
Hong Kong	1210418	單分散性聚乙二醇化納洛醇組合物 (MONODISPERSE PEGYLATED NALOXOL COMPOSITIONS)
Colombia	6700851	Conjugado de naloxol-peg cristalino

Supplementary Protection Certificates for naloxegol oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	592	Finland
1694363	C01694363/01	Switzerland		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363	PA2015019	Lithuania		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	2015/024	Ireland		PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	SPC/GB15/026	United Kingdom		PRODUCT NAME: NALOXEGOL OXALATE; REGISTERED: UK EU/1/14/962/001-011 20141210
1694363	1590027-7	Sweden		PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210

Naloxegol oxalate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naloxegol Oxalate

Introduction

Naloxegol oxalate, marketed under the brand name Movantik, is a peripherally acting μ-opioid receptor antagonist (PAMORA) designed to treat opioid-induced constipation (OIC). Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Approval and Regulatory Milestones

Naloxegol oxalate received its first approval in the United States in September 2014, marking a crucial milestone in the treatment of OIC. This approval was a result of extensive clinical trials that demonstrated the drug's safety and efficacy[4].

Market Need and Target Population

Opioid-induced constipation is a common side effect of opioid therapy, particularly in patients with chronic non-cancer pain. Naloxegol oxalate addresses this need by targeting the μ opioid receptor without affecting the central nervous system, thereby alleviating constipation without compromising pain management[4].

Competitive Landscape

The market for OIC treatments is niche but growing, driven by the increasing use of opioids for pain management. Naloxegol oxalate competes with other treatments such as lubiprostone and methylnaltrexone, but its unique mechanism of action as a PAMORA sets it apart[5].

Commercialization and Licensing

AstraZeneca, the originator of naloxegol oxalate, has engaged in several licensing agreements to expand the drug's reach. In 2016, AstraZeneca divested the rights in Europe to ProStrakan Group (now KKI) and in Canada and Israel to Knight Therapeutics. In 2020, AstraZeneca sublicensed the global rights (excluding Europe, Canada, and Israel) to RedHill Biopharma[3].

Financial Performance

In 2019, Movantik generated $96 million in sales in the United States alone. The divestment to RedHill Biopharma included an upfront payment of $52.5 million and a further non-contingent payment of $15 million in 2021. These financial transactions reflect the drug's commercial viability and the value it brings to patients and healthcare providers[3].

Manufacturing and Supply

As part of the licensing agreement with RedHill Biopharma, AstraZeneca continues to manufacture and supply Movantik during a transition period. This ensures uninterrupted availability of the drug to patients, which is crucial for maintaining market presence and customer trust[3].

Clinical Trials and Efficacy

The efficacy of naloxegol oxalate was evaluated in two replicate double-blind, placebo-controlled trials involving over 1,300 patients. These trials demonstrated significant improvements in bowel movement frequency and quality of life for patients with OIC. The drug's safety profile, including cardiovascular safety, was also favorable, with low incidence rates of major adverse cardiovascular events (MACE)[5].

Post-Marketing Commitments

Following its approval, the FDA required AstraZeneca to conduct post-marketing studies to further assess the potential interaction of naloxegol with the hepatic CYP 2C8 enzyme. These studies are part of ongoing efforts to ensure the drug's long-term safety and efficacy[5].

Market Expansion and Growth Prospects

The divestment to RedHill Biopharma is expected to enhance the global reach of Movantik, particularly in regions where opioid use is prevalent. The growing need for effective OIC treatments, coupled with the drug's proven efficacy and safety, positions naloxegol oxalate for continued market growth.

Challenges and Opportunities

Despite its advantages, naloxegol oxalate faces challenges such as competition from other OIC treatments and the need for ongoing regulatory compliance. However, its unique mechanism of action and strong clinical data provide opportunities for market differentiation and expansion into new therapeutic areas.

Financial Projections

Given the drug's established market presence and the growing demand for OIC treatments, naloxegol oxalate is expected to continue generating significant revenue. The financial projections are positive, with potential for increased sales as the drug becomes more widely adopted globally.

Conclusion

Naloxegol oxalate has established itself as a critical treatment for opioid-induced constipation, with a robust market presence and a promising financial trajectory. The drug's unique mechanism, favorable safety profile, and ongoing market expansion efforts position it for continued success in the pharmaceutical market.

Key Takeaways

• Approval and Regulatory Milestones: Naloxegol oxalate was approved in the US in 2014.
• Market Need: Addresses opioid-induced constipation, a common side effect of opioid therapy.
• Commercialization and Licensing: AstraZeneca has engaged in several licensing agreements to expand the drug's reach.
• Financial Performance: Generated $96 million in US sales in 2019; significant upfront and non-contingent payments in the divestment to RedHill Biopharma.
• Clinical Trials and Efficacy: Demonstrated significant improvements in bowel movement frequency and quality of life.
• Post-Marketing Commitments: Ongoing studies to assess potential interactions with the hepatic CYP 2C8 enzyme.
• Market Expansion and Growth Prospects: Expected to enhance global reach and grow market share.

FAQs

What is naloxegol oxalate used for?

Naloxegol oxalate is used to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Who developed naloxegol oxalate?

Naloxegol oxalate was developed by AstraZeneca PLC, using Nektar Therapeutics' oral small-molecule polymer conjugate technology[3].

What is the unique mechanism of action of naloxegol oxalate?

Naloxegol oxalate is a peripherally acting μ-opioid receptor antagonist (PAMORA), which targets the μ opioid receptor without affecting the central nervous system[4].

How was the efficacy of naloxegol oxalate evaluated?

The efficacy was evaluated in two replicate double-blind, placebo-controlled trials involving over 1,300 patients, demonstrating significant improvements in bowel movement frequency and quality of life[5].

What are the financial implications of the divestment to RedHill Biopharma?

The divestment included an upfront payment of $52.5 million and a further non-contingent payment of $15 million in 2021, reflecting the drug's commercial value[3].

Sources

1. Improved Process for the Preparation of Naloxegol Oxalate - ACS Omega, 2023.
2. Australian public assessment for naloxegol oxalate - TGA, 2016.
3. AstraZeneca divests global rights to Movantik - AstraZeneca, 2020.
4. Deep Scientific Insights on Naloxegol Oxalate's R&D Progress - Synapse, 2023.
5. 204760Orig1s000 - accessdata.fda.gov - FDA, 2014.