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NUEDEXTA Drug Patent Profile

When do Nuedexta patents expire, and when can generic versions of Nuedexta launch?

Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in twenty-one countries.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuedexta

A generic version of NUEDEXTA was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10^th, 2017.

Summary for NUEDEXTA

International Patents:	75
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	11
Drug Prices:	Drug price information for NUEDEXTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUEDEXTA
What excipients (inactive ingredients) are in NUEDEXTA?	NUEDEXTA excipients list
DailyMed Link:	NUEDEXTA at DailyMed

See drug prices for NUEDEXTA

Recent Clinical Trials for NUEDEXTA

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

Sponsor	Phase
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Cures Within Reach	Phase 3
The University of Texas Health Science Center, Houston	Phase 3

See all NUEDEXTA clinical trials

Pharmacology for NUEDEXTA

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Paragraph IV (Patent) Challenges for NUEDEXTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUEDEXTA	Capsules	dextromethorphan hydrobromide; quinidine sulfate	20 mg/10 mg	021879	1	2011-03-07

US Patents and Regulatory Information for NUEDEXTA

NUEDEXTA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes

Expired US Patents for NUEDEXTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010

EU/EMA Drug Approvals for NUEDEXTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jenson Pharmaceutical Services Limited	Nuedexta	dextromethorphan hydrobromide, quinidine sulfate	EMEA/H/C/002560 Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.	Withdrawn	no	no	no	2013-06-24

International Patents for NUEDEXTA

See the table below for patents covering NUEDEXTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010212348	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Slovenia	1539166
South Korea	101622446
Japan	2021098743	神経疾患治療のためのデキストロメトルファンおよびキニジンを含む薬剤組成物 (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR TREATMENT OF NEUROLOGICAL DISORDERS)

Supplementary Protection Certificates for NUEDEXTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	132013902215214	Italy		PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626
1539166	C 2013 034	Romania		PRODUCT NAME: COMBINATIE A DEXTROMETORFANULUI SAU A UNEI SARIACCEPTABILE FARMACEUTIC, DE EXEMPLU DEXNATIONAL AUTHORISATION NUMBER: EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF NATIONAL AUTHORISATION: 20130624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF FIRST AUTHORISATION IN EEA: 20130624 TROMETORFAN BROMHIDRAT SI PARTICULAR DEXTROMETORFAN BROMHIDRATMONOHIDRAT SI CHINIDINA SAU O SARE ACCEPTABILA FARMACEUTIC, DE EXEMPLU SULFAT DE CHINIDINA SI IN PAR TICULAR SULFATDE CHINIDINA DIHIDRAT;
1539166	C20130030 00105	Estonia		PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626

NUEDEXTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nuedexta

Introduction to Nuedexta

Nuedexta, a prescription medication developed by Avanir Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) in October 2010 for the treatment of pseudobulbar affect (PBA), a condition characterized by involuntary and uncontrollable episodes of crying or laughing not aligned with the patient's emotional state. This drug is a combination of dextromethorphan and quinidine, which allows dextromethorphan to penetrate the brain at therapeutic levels without causing peripheral toxicity[3].

Market Approval and Initial Launch

Following its FDA approval, Nuedexta was launched in February 2011. Avanir Pharmaceuticals had high expectations for the drug, aiming to capitalize on its unique mechanism of action and the lack of other treatments specifically approved for PBA. The company strengthened its balance sheet by raising $83.2 million in a public offering of common stock to support the commercialization and further development of Nuedexta[5].

Market Growth and Sales

Between 2012 and 2016, Nuedexta experienced significant market growth. The number of prescriptions dispensed to long-term care facilities increased by nearly 400%, with total sales reaching almost $300 million in 2016. This rapid growth was largely driven by aggressive marketing tactics, including targeting doctors in nursing homes and providing them with financial incentives to prescribe the drug[1][2].

Marketing Controversies and Legal Issues

Avanir's marketing strategies for Nuedexta were marred by controversy. Investigations revealed that the company had engaged in illegal off-label marketing and paid kickbacks to doctors to prescribe the drug, particularly in nursing homes. This led to a settlement with the federal government and several state governments, where Avanir agreed to pay over $100 million, including $7 million to Medicaid programs, to resolve allegations of false claims and improper marketing[1][2].

Financial Impact of Legal Settlements

The legal settlements had a substantial financial impact on Avanir and its parent company, Otsuka. The estimated cost of resolving the federal investigation was around $120 million, which included fines, damages, disgorgement, and restitution. This figure was accrued over several years, reflecting the significant financial burden imposed by the legal actions[2].

Prescription Patterns and Patient Impact

The aggressive marketing of Nuedexta led to widespread prescription in nursing homes, even though the drug had not been extensively tested in elderly patients. This resulted in serious adverse effects, including falls, broken bones, head injuries, and spinal injuries. A small study on Alzheimer’s patients showed that those taking Nuedexta experienced falls more than twice as often as those taking a placebo[1].

Market Segmentation and End-Users

The pseudobulbar treatment market, which includes Nuedexta, is segmented by drug type, treatment type, dosage form, route of administration, and end-users. Nuedexta falls under prescription drugs and is primarily administered orally. The key end-users include hospitals, specialty clinics, and homecare facilities[4].

Global Market Outlook

The global pseudobulbar treatment market is expected to grow at a CAGR of 9.30% from 2022 to 2029, reaching an estimated value of $55.9 billion. This growth is driven by increasing awareness of PBA, rising research and development activities, and a growing geriatric population. However, high treatment costs and side effects are expected to be significant restraints on market growth[4].

Competitive Landscape and Future Indications

Nuedexta's success has also led to plans for expanding its indications. Avanir has expressed interest in seeking approvals for multiple sclerosis-related pain and behavioral symptoms in dementia. The drug's potential for treating other disorders characterized by affective changes, such as depression and bipolar disorder, is also being explored[3].

Challenges and Opportunities

Despite its market success, Nuedexta faces several challenges, including the high cost of treatment, lack of skilled professionals, and limited healthcare infrastructure in developing economies. However, the increasing number of research and development activities and the growing demand for effective treatments with fewer adverse effects present opportunities for further market growth[4].

Patient Epidemiology and Market Insights

Between 2 and 7 million individuals in the United States suffer from PBA, with the lower number indicating those with more severe symptoms. The market analysis includes detailed patient epidemiology, prognosis, and treatment outcomes, which are crucial for forecasting market growth and identifying core market applications[4].

Key Takeaways

• Rapid Market Growth: Nuedexta saw a 400% increase in prescriptions to long-term care facilities between 2012 and 2016.
• Legal Controversies: Avanir faced significant legal issues due to off-label marketing and kickbacks, resulting in substantial financial penalties.
• Patient Impact: The drug's use in elderly patients led to serious adverse effects, highlighting the need for careful prescribing practices.
• Market Outlook: The global pseudobulbar treatment market is expected to grow significantly, driven by increasing awareness and research activities.
• Future Indications: Nuedexta may be approved for additional indications, expanding its market potential.

FAQs

Q: What is Nuedexta used for? A: Nuedexta is used to treat pseudobulbar affect (PBA), a condition characterized by involuntary and uncontrollable episodes of crying or laughing.

Q: Why was Avanir Pharmaceuticals involved in legal controversies? A: Avanir was involved in legal controversies due to allegations of off-label marketing and paying kickbacks to doctors to prescribe Nuedexta.

Q: How much did Avanir agree to pay in the settlement with the federal government? A: Avanir agreed to pay over $100 million, including $7 million to Medicaid programs, to resolve allegations of false claims and improper marketing.

Q: What are the potential future indications for Nuedexta? A: Nuedexta may be approved for multiple sclerosis-related pain, behavioral symptoms in dementia, and other disorders characterized by affective changes.

Q: What are the main challenges facing the pseudobulbar treatment market? A: The main challenges include high treatment costs, lack of skilled professionals, and limited healthcare infrastructure in developing economies.

Cited Sources

1. Chaffin Luhana LLP - Nuedexta Lawsuits
2. FiercePharma - Otsuka expects to shell out $120M to settle Avanir's Nuedexta marketing
3. HCPLive - Nuedexta: "Pipeline in a Pill" or Pipe Dream?
4. Data Bridge Market Research - Global Pseudobulbar Treatment Market
5. Annual Reports - Avanir Pharmaceuticals Annual Report 2010