Quinidine sulfate - Generic Drug Details

What are the generic sources for quinidine sulfate and what is the scope of patent protection?

Quinidine sulfate is the generic ingredient in four branded drugs marketed by Solvay, Lilly, Wyeth Pharms Inc, Cosette, Barr, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Cycle, Dava Pharms Inc, Elkins Sinn, Epic Pharma Llc, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, King Pharms, Kv Pharm, Lederle, Perrigo, Pharmavite, Purepac Pharm, Sandoz, Scherer Labs, Sun Pharm Industries, Superpharm, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Warner Chilcott, Watson Labs, Whiteworth Town Plsn, Key Pharms, and Schering, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for quinidine sulfate. One supplier is listed for this compound.

Summary for quinidine sulfate

US Patents:	0
Tradenames:	4
Applicants:	36
NDAs:	48
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	21
Patent Applications:	1,719
Drug Prices:	Drug price trends for quinidine sulfate
What excipients (inactive ingredients) are in quinidine sulfate?	quinidine sulfate excipients list
DailyMed Link:	quinidine sulfate at DailyMed

See drug prices for quinidine sulfate

Recent Clinical Trials for quinidine sulfate

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

Sponsor	Phase
ALS Association	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2
Holy Cross Hospital, Florida	Phase 1/Phase 2

See all quinidine sulfate clinical trials

Pharmacology for quinidine sulfate

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for quinidine sulfate

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for quinidine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	085140-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	083862-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Key Pharms	QUINORA	quinidine sulfate	TABLET;ORAL	083576-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072-002	Approved Prior to Jan 1, 1982		RX	No	Yes
Vangard	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	087909-001	Jul 13, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Quinidine Sulfate

Last updated: February 20, 2026

How is Quinidine Sulfate Positioned in the Pharmaceutical Market?

Quinidine sulfate is an antiarrhythmic agent primarily used to treat atrial fibrillation and flutter, as well as certain types of malaria. It is a class Ia sodium channel blocker, approved by the U.S. Food and Drug Administration (FDA) since 1936. The drug's manufacturing has been interrupted in recent years, but generic formulations persist.

Market Size and Key Drivers

Global Market Valuation

• Estimated global market for quinidine sulfate was valued at approximately USD 50 million in 2021.[1]
• Market is expected to grow at a Compound Annual Growth Rate (CAGR) of around 2% from 2022 to 2027, influenced by limited demand and regulatory challenges.[2]

Factors Influencing Demand

• Re-emergence of arrhythmia treatments: Increased awareness and diagnosis of atrial fibrillation worldwide drive demand.
• Drug shortages: Manufacturing discontinuations in major economies, notably the U.S., create supply constraints that favor generic imports.
• Limited alternative therapies: Availability of newer antiarrhythmics like amiodarone and sotalol diverts some demand away from quinidine sulfate.

Regional Market Dynamics

• North America: Declining due to manufacturing discontinuation and regulatory hurdles.
• Europe: Moderate demand, with some companies importing quinidine sulfate formulations.
• Asia-Pacific: Growing use due to expanding healthcare infrastructure and unregulated markets.

Market Challenges

• Manufacturing Withdrawal: Major producers ceased production citing low profitability and high regulatory costs. USA’s only FDA-approved producer, Sigma-Aldrich (now part of MilliporeSigma), halted production in 2019.[3]
• Regulatory Restrictions: Strict regulations in the U.S. and European countries restrict market entry for new formulations.
• Side Effect Profile: Risk of hypotension, cinchonism, and arrhythmias limits widespread use, favoring newer agents with better safety profiles.

Financial Trajectory and Investment Outlook

Revenue Trends

• Revenue declines are evident in the US market, where the drug is seldom marketed.
• Imports from overseas sources in Europe and Asia have maintained some revenue stream.
• Total global revenues are expected to decrease modestly over the next five years unless new formulations or indications are developed.

Market Players and Supply Chain

• Current Suppliers: Limited to generic drug makers in India and China exporting quinidine sulfate abroad.
• Potential Entrants: Entry is constrained by manufacturing costs, regulatory compliance, and limited market size.

R&D and Market Expansion Opportunities

• Some research on novel formulations (e.g., extended-release) exists but remains in early stages.
• Development of alternative indications, such as certain parasitic diseases or new arrhythmia subtypes, could alter the financial landscape.

Competitive and Regulatory Outlook

• Ongoing regulatory tightening emphasizes safety, reducing likelihood for new entrants.
• Patent clearance is unnecessary for generics since quinidine sulfate is off patent.
• Potential for targeted reformulations or combination products may present niche opportunities.

Summary Table

Aspect	Details
Market Size (2021)	USD 50 million
Expected CAGR (2022–2027)	2%
Major Demand Drivers	Arrhythmia treatments, supply shortages
Major Challenges	Manufacturing discontinuation, safety concerns, regulation
Key Regions	North America (declining), Europe (stable), Asia-Pacific (growing)
Main Suppliers	Generic pharmaceutical companies in India and China
R&D Status	Early-stage, limited pipeline for new formulations

Key Takeaways

• Quinidine sulfate market is shrinking due to manufacturing withdrawals and safety concerns.
• Demand persists mainly through imports, with regional variations.
• Limited R&D indicates minimal near-term innovation, though niche opportunities may exist.
• Regulatory hurdles and safety profiles constrain new market entrants.
• Market value is expected to decline modestly unless formulations or new indications are developed.

FAQs

1. What factors are contributing to the decline of quinidine sulfate's market?
   Manufacturing discontinuations, safety profile issues, and competition from newer antiarrhythmics reduce market size.

2. Are there upcoming regulatory changes that could impact quinidine sulfate?
   Regulatory agencies emphasize safety, which may further restrict use and approve fewer formulations or indications.

3. What regions are most likely to sustain quinidine sulfate demand?
   Asia-Pacific countries and regions with less stringent regulations may maintain modest demand.

4. What are the prospects for R&D related to quinidine sulfate?
   Early-stage research exists but faces hurdles due to safety concerns and limited commercial incentives.

5. Can quinidine sulfate be repositioned for new indications?
   Potential exists in niche parasitic disease treatment, but evidence and development costs limit prospects.

References

[1] MarketResearch.com. (2022). Global pharmaceutical market reports.
[2] Transparency Market Research. (2022). Antiarrhythmic drugs market outlook.
[3] FDA. (2019). Drug shortages and manufacturing discontinuations.

[1] MarketResearch.com. (2022). Global pharmaceutical market reports.
[2] Transparency Market Research. (2022). Antiarrhythmic drugs market outlook.
[3] FDA. (2019). Drug shortages and manufacturing discontinuations.