NAMENDA XR Drug Patent Profile

Which patents cover Namenda Xr, and when can generic versions of Namenda Xr launch?

Namenda Xr is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Namenda Xr

A generic version of NAMENDA XR was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14^th, 2010.

Summary for NAMENDA XR

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	76
Patent Applications:	2,697
Drug Prices:	Drug price information for NAMENDA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMENDA XR
DailyMed Link:	NAMENDA XR at DailyMed

See drug prices for NAMENDA XR

See drug sales revenues for NAMENDA XR

Recent Clinical Trials for NAMENDA XR

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

Sponsor	Phase
University of Chicago	Phase 2/Phase 3
Children's Hospital Medical Center, Cincinnati	Early Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1

See all NAMENDA XR clinical trials

Pharmacology for NAMENDA XR

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

Paragraph IV (Patent) Challenges for NAMENDA XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAMENDA XR	Extended-release Capsules	memantine hydrochloride	7 mg, 14 mg, 21 mg, and 28 mg	022525	1	2013-06-10

US Patents and Regulatory Information for NAMENDA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010		DISCN	Yes	No					Y
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010		DISCN	Yes	No					Y
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010		DISCN	Yes	No					Y

Expired US Patents for NAMENDA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010

EU/EMA Drug Approvals for NAMENDA XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merz Pharmaceuticals GmbH	Memantine Merz	memantine hydrochloride	EMEA/H/C/002711 Treatment of patients with moderate to severe Alzheimer’s disease.	Authorised	no	no	no	2012-11-22

International Patents for NAMENDA XR

See the table below for patents covering NAMENDA XR 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

Supplementary Protection Certificates for NAMENDA XR

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
0392059	90988	Luxembourg
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517

NAMENDA XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Namenda XR

Introduction

Namenda XR, a once-daily formulation of memantine hydrochloride, is a crucial drug in the treatment of moderate to severe dementia related to Alzheimer’s disease. Developed by Forest Laboratories and later managed by Actavis (now part of Allergan), the drug's market dynamics and financial trajectory are influenced by several key factors, including patent exclusivity, generic competition, and strategic marketing maneuvers.

Background of Namenda XR

Namenda XR was launched in June 2013 as a controlled-release version of the approved CNS drug memantine. It is designed to offer patients a more convenient once-daily dosing regimen compared to the twice-daily Namenda IR formulation[3].

Patent Exclusivity and Generic Competition

The patent exclusivity period for Namenda XR has been a significant factor in its market dynamics. The drug was protected from generic competition until 2029, which allowed Actavis to maintain a strong market position. However, the approach to handling the transition from Namenda IR to Namenda XR was critical in mitigating the impact of generic competition.

Actavis devised a strategy to remove Namenda IR from the market before the generic versions of Namenda IR could enter, thereby forcing patients to switch to Namenda XR. This strategy aimed to limit the financial impact of generic competition on the brand[1][4].

Financial Impact of Generic Competition

The financial implications of this strategy were substantial. According to an ASPE issue brief, if generic versions of Namenda IR had entered the market without the removal of Namenda IR, the total spending on Namenda products over a ten-year period (2015-2024) would have been significantly reduced. For instance, under a scenario where generic competition was allowed, the total spending would have dropped from approximately $37 billion to nearly $13 billion. However, with the removal of Namenda IR and the dominance of Namenda XR, the reduction in spending was limited to about $6 billion[1].

Market Strategy and Judicial Intervention

Actavis's plan to switch patients from Namenda IR to Namenda XR was challenged in court. A New York judge issued an injunction preventing Actavis from pulling Namenda IR off the market, citing concerns about the lack of a generic alternative and the potential harm to patients. This judicial intervention disrupted Actavis's strategy and set a precedent for future hard switch attempts by pharmaceutical companies[4].

Financial Performance of Namenda XR

Despite the challenges, Namenda XR has been a significant contributor to the financial performance of its parent companies. The drug's once-daily formulation and extended patent exclusivity helped maintain high sales figures. For example, the launch of Namenda XR and its combination product, Namzaric (which combines memantine with donepezil), generated substantial revenues. By 2015, these products were key components of the company's portfolio, with royalties from their sales expected to commence five years after their launch[3].

Impact on Healthcare Costs

The strategy of transitioning patients to Namenda XR had significant implications for healthcare costs. By limiting generic competition, Actavis's approach increased spending on Namenda products. This is particularly relevant given the rising number of individuals with dementia; the number of individuals in the U.S. over age 65 with dementia from Alzheimer’s disease is projected to rise from 4.7 million in 2010 to 14.8 million by 2050. Efforts to contain healthcare costs while maintaining clinical value are critical, and policies encouraging the use of generic drugs play a key role in cost control[1].

Industry Expert Insights

Industry experts have highlighted the importance of strategic planning in managing the transition from brand-name drugs to generics. CEO Brent Saunders of Actavis publicly stated the company's intention to move patients to the XR version to prevent the financial impact of patent loss, illustrating the proactive approach companies take to manage their product lifecycles[4].

Market Attractiveness and Patient Preferences

The market attractiveness of Namenda XR is also influenced by patient preferences and clinical benefits. The once-daily dosing regimen offers greater convenience and adherence, which can be particularly beneficial for patients with chronic conditions like Alzheimer’s disease. This convenience factor, combined with the therapeutic benefits, has helped Namenda XR maintain a strong market position despite the challenges posed by generic competition[3].

Regulatory and Developmental Aspects

The development and commercialization of Namenda XR involved a complex regulatory process. The company's integrated product development strategy, which includes in-depth knowledge of CNS markets, pharmacokinetic and pharmacodynamic competencies, and regulatory expertise, was crucial in bringing this product to market. This approach allowed for the creation of clinically differentiated products that address significant unmet clinical needs[3].

Conclusion

The market dynamics and financial trajectory of Namenda XR are characterized by a combination of strategic marketing, patent exclusivity, and regulatory factors. Actavis's attempt to transition patients from Namenda IR to Namenda XR, though challenged in court, highlights the complexities of managing brand-name drugs in the face of generic competition. The financial implications of these strategies are significant, influencing both company revenues and healthcare costs.

Key Takeaways

• Strategic Transition: Actavis's strategy to remove Namenda IR from the market to promote Namenda XR was aimed at mitigating the financial impact of generic competition.
• Financial Impact: The strategy resulted in increased spending on Namenda products, with a minimum increase of $6 billion over a ten-year period.
• Judicial Intervention: A New York judge's injunction prevented Actavis from pulling Namenda IR off the market, setting a precedent for future hard switch attempts.
• Healthcare Costs: The approach increased healthcare costs, particularly significant given the rising number of individuals with dementia.
• Market Attractiveness: Namenda XR's once-daily dosing regimen offers convenience and adherence benefits, contributing to its market attractiveness.

FAQs

Q: What is the primary difference between Namenda IR and Namenda XR? A: Namenda IR is a twice-daily formulation, while Namenda XR is a once-daily extended-release formulation of memantine hydrochloride.

Q: Why did Actavis plan to remove Namenda IR from the market? A: Actavis aimed to transition patients to Namenda XR to limit the financial impact of generic competition when the patent for Namenda IR expired.

Q: How did the judicial intervention affect Actavis's strategy? A: A New York judge's injunction prevented Actavis from pulling Namenda IR off the market, disrupting their strategy and setting a legal precedent.

Q: What are the projected healthcare cost implications of Actavis's strategy? A: The strategy is estimated to increase spending on Namenda products by at least $6 billion over a ten-year period.

Q: How does Namenda XR's dosing regimen impact patient adherence? A: The once-daily dosing regimen of Namenda XR offers greater convenience and can improve patient adherence, particularly beneficial for patients with chronic conditions like Alzheimer’s disease.

Sources

1. ASPE Issue Brief: "Generic Market Entry and the Pricing of Pharmaceuticals" - ASPE, May 2015.
2. Allergan Financial Results: "Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results" - PR Newswire, February 2020.
3. Annual Report: "Putting the Pieces in Place" - Annual Reports, 2015.
4. FiercePharma: "Marketing lesson from Actavis' Namenda ruling: For a hard switch, keep your mouths shut" - FiercePharma, December 2014.