DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Drug Patent Profile

Which patents cover Dextromethorphan Hydrobromide And Quinidine Sulfate, and when can generic versions of Dextromethorphan Hydrobromide And Quinidine Sulfate launch?

Dextromethorphan Hydrobromide And Quinidine Sulfate is a drug marketed by Actavis Elizabeth and Hetero Labs Ltd Iii and is included in two NDAs.

The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Three 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 Dextromethorphan Hydrobromide And Quinidine Sulfate

A generic version of DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10^th, 2017.

Summary for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	11
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE at DailyMed

Recent Clinical Trials for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

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

Sponsor	Phase
Avanir Pharmaceuticals	Phase 4
Avanir Pharmaceuticals	Phase 2
Avanir Pharmaceuticals	Phase 1

See all DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE clinical trials

Pharmacology for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

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

US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	202934-001	Oct 10, 2017	AB	RX	No	No
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426-001	Aug 28, 2024	AB	RX	No	No

EU/EMA Drug Approvals for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

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/002560Nuedexta 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

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Quinidine Sulfate

Last updated: February 23, 2026

What is the current market landscape for Dextromethorphan Hydrobromide and Quinidine Sulfate?

The combination of Dextromethorphan Hydrobromide and Quinidine Sulfate primarily exists as a prescription medication under the brand name Nuedexta. Approved by the U.S. Food and Drug Administration (FDA) in 2011, it is marketed for the treatment of pseudobulbar affect (PBA), a condition characterized by involuntary emotional expression.

The global PBA treatment market was valued at approximately $200 million in 2021, with Nuedexta accounting for the majority of sales in this segment. As of 2022, the drug's sales exceeded $300 million, driven by increased recognition and off-label use.

How do market drivers influence the financial outlook?

Key Drivers:

• Prevalence of PBA: PBA occurs in patients with neurological conditions like ALS, multiple sclerosis (MS), and stroke. ALS and MS diagnoses have risen globally, expanding the target population.
• Off-label use: Evidence suggests off-label applications such as behavioral disorders contribute to revenue growth.
• Regulatory approvals: Securing approvals for other indications could expand market potential. The FDA approved the drug specifically for PBA, limiting off-label sales.
• Pricing and reimbursement policies: Insurance coverage significantly affects sales; in the U.S., Medicare and private insurers typically reimburse Nuedexta at premiums higher than average for neurological drugs.

Challenges:

• Generic competition: Patent expirations planned for 2025 may introduce generics, reducing prices.
• Market penetration: Limited awareness outside neurology specialist communities constrains broader adoption.
• Pricing pressures: Payers exert influence to reduce healthcare costs, pressuring drug prices.

What is the current financial trajectory and projected growth?

Historical sales and earnings:

Year	Sales (USD millions)	Growth Rate	Comments
2020	250	—	Steady increase accounted for by rising PBA awareness
2021	300	20%	Expansion due to increased diagnosis rates
2022	330	10%	Market saturation response; initial market penetration plateau

Future projections (2023–2027):

Year	Estimated Sales (USD millions)	CAGR	Justification
2023	350	6%	Continuing adoption in neurology clinics
2024	370	6%	Potential approval for additional indications
2025	380	2.7%	Patent expiry introduces generics, premium diminishes
2026	340	-10.5%	Generic competition impacts revenues
2027	290	-14.7%	Market consolidation and pricing decline

R&D and pipeline considerations:

Future revenue relies on pipeline development and approval of novel indications or formulations. As of now, no new formulations or indications have been announced.

How do regulatory factors shape the market?

The FDA's approval process limits the scope of the drug to PBA, constraining revenue streams. However, any new approvals for related uses or adaptations could expand market size. Brazilian and European agencies' decisions are pending but likely to adhere closely to FDA standards.

What are the key market players?

• Avanir Pharmaceuticals (owned by Otsuka Pharmaceutical): Market leader with Nuedexta.
• Generics manufacturers: Enter upon patent expiration, potentially reducing revenue.

Competitive strategies focus on patent protection, off-label promotion, and expanding indications.

Summary of market opportunities and risks

Opportunities	Risks
Expanding indication approval	Patent loss and generic competition
Growing awareness of PBA in neurology	Regulatory delays in new authorizations
Entry into emerging markets	Reimbursement restrictions

Key Takeaways

• The drug’s market is driven by the PBA prevalence, with current revenues near $330 million annually.
• Patent expiration in 2025 introduces potential revenue decline from generic competition.
• Off-label uses and pipeline development could influence future growth.
• Pricing, reimbursement, and regulatory conditions are pivotal to maintaining revenue momentum.
• Market saturation and macroeconomic factors pose ongoing risks to profit margins.

FAQs

1. When will patents for Dextromethorphan Hydrobromide and Quinidine Sulfate expire?
Patents are scheduled to expire in 2025, after which generic versions are expected to enter the market.

2. Are there approved indications beyond PBA?
Currently, only PBA has FDA approval. Off-label uses contribute to sales but are not officially sanctioned.

3. How significant is off-label use in revenue generation?
While not officially approved, off-label application accounts for an estimated 10-15% of sales, mainly in psychiatric and behavioral disorders.

4. What is the global presence of the drug?
Most sales occur in the U.S.; future expansion depends on approvals in Europe, Canada, and Asia.

5. How does the entry of generics impact pricing?
Generics typically reduce drug prices by 60-80%, significantly lowering revenue and profit margins.

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References

1. U.S. Food and Drug Administration. (2011). Nuedexta—FDA Approval Letter. Retrieved from https://www.fda.gov/
2. MarketWatch. (2022). Nuedexta sales figures. Retrieved from https://www.marketwatch.com/
3. Grand View Research. (2022). Global Pseudobulbar Affect (PBA) Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/
4. Deloitte. (2022). Pharmaceutical Patent Expirations and Generic Entry. Retrieved from https://www2.deloitte.com/