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NAMZARIC Drug Patent Profile

Which patents cover Namzaric, and what generic alternatives are available?

Namzaric is a drug marketed by Abbvie and is included in one NDA. There are twelve patents protecting this drug and three Paragraph IV challenges.

This drug has sixty-seven patent family members in nineteen countries.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Namzaric

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (donepezil hydrochloride; memantine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NAMZARIC

International Patents:	67
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	34
Drug Prices:	Drug price information for NAMZARIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMZARIC
What excipients (inactive ingredients) are in NAMZARIC?	NAMZARIC excipients list
DailyMed Link:	NAMZARIC at DailyMed

See drug prices for NAMZARIC

Recent Clinical Trials for NAMZARIC

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

Sponsor	Phase
Duke University	Phase 3
Varian Medical Systems	Phase 3
Allergan	Phase 3

See all NAMZARIC clinical trials

Pharmacology for NAMZARIC

Drug Class	Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cholinesterase Inhibitors NMDA Receptor Antagonists

Paragraph IV (Patent) Challenges for NAMZARIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	7 mg/10 mg	206439	1	2016-09-26
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	21 mg/10 mg	206439	1	2016-09-23
NAMZARIC	Capsules	donepezil hydrochloride; memantine hydrochloride	14 mg/10 mg and 28 mg/10 mg	206439	1	2015-05-18

US Patents and Regulatory Information for NAMZARIC

NAMZARIC is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No

Expired US Patents for NAMZARIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014

EU/EMA Drug Approvals for NAMZARIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
H. Lundbeck A/S	Acrescent	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002424 Treatment of Alzheimers disease	Refused	no	no	no		2013-02-20
Merz Pharmaceuticals GmbH	Balaxur	memantine hydrochloride, donepezil hydrochloride	EMEA/H/C/002708	Refused	no	no	no		2013-02-20

International Patents for NAMZARIC

When does loss-of-exclusivity occur for NAMZARIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NAMZARIC around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	215592	Eljárás adamantánszármazékokat tartalmazó agyi ischemia megelőzésére és kezelésére alkalmas gyógyászati készítmények előállítására (PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION CONTAINING ADAMANTANE DERIVATIVES FOR TREATING AND PROFILACTING CEREBRAL ISCHEMIA)
Mexico	2007006120	METODO Y COMPOSICION PARA ADMINISTRAR A UN SUJETO UN ANTAGONISTA DEL RECEPTOR DE NMDA. (COMPOSITION COMPRISING A SUSTAINED RELEASE COATING OR MATRIX AND AN NMDA RECEPTOR ANTAGONIST, METHOD FOR ADMINISTRATION SUCH NMDA ANTAGONIST TO A SUBJECT.)
Denmark	1874282
European Patent Office	1789028	COMPOSITIONS POUR LE TRAITEMENT DE LA DOULEUR NOCICEPTIVE (COMPOSITIONS FOR TREATING NOCICEPTIVE PAIN)
South Africa	200709535	Methods and compositions for the treatment of CNS-related conditions
Spain	2059602

Supplementary Protection Certificates for NAMZARIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0296560	SPC/GB97/023	United Kingdom		PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
0392059	90988	Luxembourg
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0296560	2/1998	Austria		PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0392059	SPC/GB02/046	United Kingdom		PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515

NAMZARIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NAMZARIC

Introduction

NAMZARIC, a combination drug of donepezil and memantine, was launched in the US in 2015 for the treatment of moderate-to-severe Alzheimer’s disease. Here, we delve into the market dynamics and financial trajectory of NAMZARIC, highlighting its performance, market impact, and future projections.

Market Launch and Initial Performance

NAMZARIC was introduced to the market in May 2015, combining two commonly prescribed Alzheimer’s drugs, donepezil and memantine, into a single capsule. Despite the lack of significant differentiation from generic versions of these drugs, NAMZARIC has managed to generate substantial revenue. In its first year, the drug achieved sales of around $90 million, which steadily increased to over $200 million annually by 2017[3].

Sales Growth and Revenue

The sales of NAMZARIC have shown a consistent growth pattern. From 2015 to 2020, the drug's annual sales ranged from $90 million to $267 million. This growth is notable, especially considering that the drug has not been actively promoted since 2018. By 2020, NAMZARIC's yearly sales had stabilized around $200-250 million[3].

Market Share and Competition

NAMZARIC operates in a competitive Alzheimer’s disease market, where it faces competition from both branded and generic versions of its constituent drugs. Despite this, it has managed to capture a significant market share. The drug's sales are driven by its convenience as a single-dose capsule, although many physicians still prescribe the generic versions of donepezil and memantine separately[1].

Financial Projections

Financial projections indicate that NAMZARIC's sales will continue to grow, albeit at a slower rate. By 2025, the peak sales of NAMZARIC are forecast to reach $574.1 million, after which they are expected to decline due to the expiration of its patent and the subsequent availability of generic versions[1].

Impact on the Alzheimer’s Disease Market

NAMZARIC's presence in the Alzheimer’s disease market has been significant, particularly in the moderate-to-severe segment. However, its impact is overshadowed by the broader market dynamics, which are driven by the development of novel disease-modifying therapies (DMTs). The Alzheimer’s disease market is expected to grow at a Compound Annual Growth Rate (CAGR) of 17.5% from 2016 to 2026, driven by the introduction of biologics and other DMTs[1].

Regional Access and Pricing

NAMZARIC has a wide reach, with approximately 75% of Medicare Advantage lives having access to the drug. The average co-pay for NAMZARIC ranges from $50 to $67.50, and the average retail price is around $667.74. This pricing strategy has helped maintain a steady customer base despite the lack of active promotion[3].

Future Outlook

The future outlook for NAMZARIC is mixed. While it is expected to continue generating revenue, its sales will likely decline post-2025 due to patent expiration. The broader Alzheimer’s disease market, however, is poised for significant growth driven by innovative therapies. Monoclonal antibody-based immunotherapies and BACE inhibitors are expected to dominate the market, with drugs like aducanumab leading the charge[1].

Conclusion on Market Dynamics

NAMZARIC's market dynamics are characterized by steady sales growth despite minimal differentiation and lack of promotion. Its financial trajectory is marked by peak sales in the mid-2020s followed by a decline. The drug's success underscores the demand for convenient treatment options in the Alzheimer’s disease market, even as the market shifts towards more innovative and disease-modifying therapies.

Key Takeaways

• Steady Sales Growth: NAMZARIC has shown consistent sales growth since its launch in 2015.
• Peak Sales Forecast: Peak sales are expected to reach $574.1 million by 2025.
• Decline Post-Patent Expiration: Sales are anticipated to decline after 2025 due to patent expiration.
• Market Competition: Faces competition from generic versions of donepezil and memantine.
• Broader Market Trends: The Alzheimer’s disease market is growing rapidly due to the introduction of novel DMTs.

FAQs

What is NAMZARIC and how does it treat Alzheimer’s disease?

NAMZARIC is a combination drug of donepezil and memantine, used to treat moderate-to-severe Alzheimer’s disease. It combines two commonly prescribed drugs into a single capsule for convenience.

How has NAMZARIC performed in terms of sales since its launch?

NAMZARIC has shown steady sales growth since its launch in 2015, reaching annual sales of over $200 million by 2017 and stabilizing around $200-250 million by 2020.

What are the financial projections for NAMZARIC?

Peak sales of NAMZARIC are forecast to reach $574.1 million by 2025, after which sales are expected to decline due to patent expiration.

How does NAMZARIC fit into the broader Alzheimer’s disease market?

NAMZARIC operates in a competitive market but has managed to capture a significant share. However, the broader market is driven by the development of novel disease-modifying therapies.

What factors contribute to the pricing and access of NAMZARIC?

NAMZARIC has wide access with approximately 75% of Medicare Advantage lives covered, and it has an average co-pay of $50 to $67.50, with an average retail price of around $667.74.

Sources

1. MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026) - Drug Development
2. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results - AbbVie News
3. Corporate Presentation - Alpha Cognition
4. Alzheimers Drugs Market Size, Share | Forecast Report [2030] - Fortune Business Insights
5. Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results - AbbVie News