RIMANTADINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Rimantadine Hydrochloride, and when can generic versions of Rimantadine Hydrochloride launch?
Rimantadine Hydrochloride is a drug marketed by Chartwell Rx, Impax Labs, and Impax Labs Inc. and is included in three NDAs.
The generic ingredient in RIMANTADINE HYDROCHLORIDE is rimantadine hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rimantadine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rimantadine Hydrochloride
A generic version of RIMANTADINE HYDROCHLORIDE was approved as rimantadine hydrochloride by IMPAX LABS on August 30th, 2002.
US Patents and Regulatory Information for RIMANTADINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chartwell Rx | RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 076375-001 | Jan 14, 2003 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax Labs | RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 076132-001 | Aug 30, 2002 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax Labs Inc | RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 075916-001 | Nov 2, 2001 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Summary:
Rimantadine hydrochloride, an antiviral drug primarily used to treat influenza A, has experienced declining clinical relevance due to resistance from circulating viral strains. It remains of interest for niche applications and generic markets but faces limited growth prospects. Investment in R&D or production hinges on regulatory status, resistance trends, and patent expiration. Its fundamentals indicate modest profitability unless new indications or formulations emerge.
What Is the Current Market and Regulatory Status of Rimantadine Hydrochloride?
Rimantadine hydrochloride's primary approval originated in the 1960s. The FDA revoked its indication for influenza A treatment in 2006 due to widespread resistance but retains approval for prophylaxis in certain high-risk populations. Its market presence is mostly generic, with no recent major patent protections. Globally, regulatory authorities’ stance varies. For example, EMA guidelines have deprecated its use, reducing off-label utilization.
Patent and Market Dynamics:
- Patent expiration: Generally in the early 2000s, leading to generic prevalence.
- Market size (2022): Estimated less than $50 million globally, mainly in legacy markets.
- Competition: Multiple manufacturers produce generic rimantadine, exerting price pressure.
What Are the Key Scientific and Clinical Limitations?
Resistance has rendered Rimantadine largely ineffective against current circulating influenza strains. The resistance rate in circulating viruses exceeds 90%. Its antiviral mechanism, blocking the M2 ion channel, is targeted by mutations in viral strains, increasing resistance.
Potential for New Clinical Uses:
- Limited, as resistance diminishes effectiveness.
- Minor investigations exist into off-label uses, such as Parkinsonian symptoms, but lack clinical validation.
Formulation and Delivery:
No significant innovation in dosing forms; mainly oral tablets. The development of new formulations appears commercially unattractive given resistance challenges.
How Does the Competitive Landscape Look?
- Market dominance is with generic manufacturers.
- No recent patent filings or exclusivity periods.
- Pharmaceutical thermometers or antivirals with newer mechanisms dominate influenza management.
- Investors face minimal upward potential unless a novel use or formulation is developed.
Investment Considerations:
- Existing products are mature, with little room for premium pricing.
- R&D costs are high, with low chance of success absent new indications.
- Regulatory constraints and resistance trends limit growth.
What Are the Opportunities and Risks?
Opportunities:
- Niche applications in specific populations or regions with limited access to newer antivirals.
- Development of combination therapies that include rimantadine derivatives.
- Reformulation or drug delivery innovations to improve compliance.
Risks:
- Further resistance development reducing efficacy.
- Regulatory restrictions or removal from formularies.
- Market obsolescence driven by newer therapeutics like baloxavir marboxil or favipiravir.
| Key Investment Fundamentals Summary: | Factor | Evaluation | Rationale |
|---|---|---|---|
| Patent protection | Expired, minimal current exclusivity | Generic competition dominates | |
| Market size | Small, stagnant, declining | Resistance limits use; market shrinking | |
| R&D pipeline | Minimal, no recent development | Focus on new applications unlikely | |
| Regulatory environment | Restrictive, with limited approved indications | Restrictions limit use and growth | |
| Competitive landscape | Highly commoditized, low profit margins | Competitive pressures depress pricing |
Key Takeaways:
- Rimantadine hydrochloride has limited current therapeutic value due to resistance.
- Market is mature, dominated by generics, with limited growth or pricing power.
- Investors should focus on niche applications, reformulation, or derivative development rather than core product expansion.
- Regulatory and resistance trends pose ongoing risks to market relevance.
- Exploration of new indications or delivery methods could create minimal upside but remain uncertain.
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