TACRINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for tacrine hydrochloride and what is the scope of patent protection?
Tacrine hydrochloride
is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for tacrine hydrochloride.
Summary for TACRINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 5 |
| DailyMed Link: | TACRINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for TACRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Midwest Biomedical Research Foundation | Phase 2 |
| National Institute on Drug Abuse (NIDA) | Phase 2 |
| Northwell Health | Phase 4 |
Medical Subject Heading (MeSH) Categories for TACRINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TACRINE HYDROCHLORIDE
US Patents and Regulatory Information for TACRINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-001 | Sep 9, 1993 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-004 | Sep 9, 1993 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-002 | Sep 9, 1993 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-003 | Sep 9, 1993 | 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 |
Expired US Patents for TACRINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-001 | Sep 9, 1993 | 4,631,286 | ⤷ Start Trial |
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-003 | Sep 9, 1993 | 4,816,456 | ⤷ Start Trial |
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-004 | Sep 9, 1993 | 4,816,456 | ⤷ Start Trial |
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-001 | Sep 9, 1993 | 4,816,456 | ⤷ Start Trial |
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-003 | Sep 9, 1993 | 4,631,286 | ⤷ Start Trial |
| Shionogi Inc | COGNEX | tacrine hydrochloride | CAPSULE;ORAL | 020070-002 | Sep 9, 1993 | 4,816,456 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Summary
Tacrine hydrochloride was the first acetylcholinesterase inhibitor approved for Alzheimer's disease treatment. Its market presence has declined due to safety concerns and the development of superior therapies. Currently, it has minimal commercial activity, with the primary value as a research tool rather than a commercial product.
What Is the Current Market Status of Tacrine Hydrochloride?
Tacrine hydrochloride was approved by the U.S. Food and Drug Administration (FDA) in 1993 under the brand name Cognex. The drug was mainly used for mild to moderate Alzheimer's disease. Recognition of hepatotoxicity led to decreased prescribing and eventual withdrawal of some formulations. Several manufacturers ceased production or limited distribution by the early 2000s.
- Market presence: Nearly obsolete in clinical practice in North America and Europe. Limited distribution remains in some markets or for research purposes.
- Manufacturers: Most companies exited commercial manufacturing by 2005. Today, it exists primarily as a research chemical through specialty suppliers.
- Regulatory status: Withdrawn from many markets due to safety issues. United States: terminated marketing in 2013 after safety concerns escalated.
What Factors Have Driven Market Decline?
The decline stems from safety issues and the advent of better therapies.
- Hepatotoxicity: Elevated liver enzymes and instances of liver failure reported, prompting warnings and contraindications.
- Efficacy limitations: Modest benefit in cognitive functions; limited long-term impact.
- Alternative treatments: Introduction of safer and more effective drugs, such as donepezil, rivastigmine, and galantamine, which have better safety profiles.
- Regulatory actions: The FDA and European Medicines Agency (EMA) restricted or withdrew tacrine due to safety concerns.
How Does Tacrine Hydrochloride Compare to Competitors?
Compared to newer acetylcholinesterase inhibitors:
| Feature | Tacrine Hydrochloride | Donepezil | Rivastigmine | Galantamine |
|---|---|---|---|---|
| Approval Year | 1993 | 1996 | 2000 | 2001 |
| Indications | Mild to moderate Alzheimer’s | Mild to severe Alzheimer’s | Mild to moderate Alzheimer’s | Mild to moderate Alzheimer’s |
| Safety Profile | Hepatotoxicity, gastrointestinal issues | Generally well tolerated | Gastrointestinal, dizziness | Gastrointestinal, bradycardia |
| Market Availability | Minimal, research-only | Widely prescribed | Widely prescribed | Widely prescribed |
| Price (per tablet) | Historically low (generic) | Approximately $2–$4 in the U.S. | Approximately $3–$5 | Approximately $2–$4 |
What Is the Financial Trajectory for Tacrine Hydrochloride?
The financial pathway for tacrine is characterized by obsolescence.
- Sales volume: Virtually nonexistent in recent years; earlier sales peaked in the early 2000s before rapidly declining.
- Revenue: Estimated at hundreds of thousands of dollars globally until market withdrawal; negligible thereafter.
- Research use: Maintains some niche value in academic and preclinical research.
- Impact on companies: Manufacturing ceased, and no major biotech firms currently patent or sell tacrine for marketed indications.
What Are Future Trends and Opportunities?
Given its safety profile, tacrine's future resides mainly in niche or experimental settings.
- Research applications: Murine models and in vitro studies benefit from its mechanism.
- Developmental insights: Lessons inform safety considerations for acetylcholinesterase inhibitors.
- Market prospects: No significant commercial development expected; potential licensing or generic manufacturing remains theoretical.
Summary of Market and Financial Outlook
Tacrine hydrochloride has little to no commercial presence and is effectively obsolete in the treatment of Alzheimer's disease. Its primary value is as a historical benchmark and research reagent. The shift towards safer, more efficacious drugs has eliminated profitability from market sales. Any ongoing financial activity involves minimal licensing, research use, or residual royalties from early patents.
Key Takeaways
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