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PARGYLINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for pargyline hydrochloride and what is the scope of freedom to operate?
Pargyline hydrochloride
is the generic ingredient in one branded drug marketed by Abbott and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for PARGYLINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 100 |
| Clinical Trials: | 1 |
| DailyMed Link: | PARGYLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PARGYLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| US Department of Veterans Affairs | |
| VA Office of Research and Development |
Medical Subject Heading (MeSH) Categories for PARGYLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PARGYLINE HYDROCHLORIDE
US Patents and Regulatory Information for PARGYLINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | EUTONYL | pargyline hydrochloride | TABLET;ORAL | 013448-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbott | EUTONYL | pargyline hydrochloride | TABLET;ORAL | 013448-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbott | EUTONYL | pargyline hydrochloride | TABLET;ORAL | 013448-002 | Approved Prior to Jan 1, 1982 | 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 |
Pargyline Hydrochloride Market Dynamics and Financial Trajectory
Pargyline hydrochloride is a discontinued monoamine oxidase inhibitor that was marketed historically as an antihypertensive, primarily under the brand name Eutonyl. It has no meaningful current commercial market, no identifiable active U.S. sponsor, no current FDA marketing position, and no publicly reported revenue base. Its patent and exclusivity profile is commercially immaterial because the product’s historical protection expired decades ago and the drug is no longer a mainstream development asset.
What is the current market status of pargyline hydrochloride?
Pargyline hydrochloride is not an active commercial pharmaceutical product in the United States. Historical use centered on hypertension before newer antihypertensive classes displaced irreversible monoamine oxidase inhibitors.
| Metric | Pargyline hydrochloride status |
|---|---|
| Active ingredient | Pargyline hydrochloride |
| Pharmacology | Irreversible monoamine oxidase inhibitor |
| Historical indication | Hypertension |
| Historical brand | Eutonyl |
| Current U.S. commercial status | Discontinued |
| Current FDA promotional market | None identified |
| Current generic competition | No meaningful active market identified |
| Current biosimilar risk | Not applicable |
| Current branded revenue | No publicly reported revenue |
| Commercial development activity | No material current activity identified |
Pargyline is listed in public drug databases as a discontinued drug. PubChem identifies pargyline hydrochloride as the hydrochloride salt of pargyline and records its monoamine oxidase inhibitor activity. The product is absent from current mainstream hypertension treatment because its risk-benefit profile is less favorable than that of ACE inhibitors, angiotensin receptor blockers, calcium-channel blockers, thiazide diuretics, and beta blockers.[1]
When did pargyline hydrochloride lose exclusivity?
Pargyline hydrochloride lost practical market exclusivity many decades ago. The product was developed and commercialized during the mid-20th century, before the modern Hatch-Waxman framework and current patent-term-restoration system.
No active U.S. composition-of-matter patent or market exclusivity period is commercially relevant today. Any original compound patent would have expired long before the present period. Historical formulations and method-of-use claims also would not support a present-day branded monopoly absent a new, valid, and enforceable patent, and no such current estate is evident in public U.S. regulatory records.
Historical exclusivity timeline
| Period | Commercial and legal position |
|---|---|
| Mid-20th century | Pargyline developed as an irreversible monoamine oxidase inhibitor |
| Historical launch period | Marketed as Eutonyl for hypertension |
| 1970s-1980s | Older antihypertensive product class displaced by newer agents |
| Pre-Hatch-Waxman era | Historical patent rights would have run under older patent-term rules |
| Current period | No meaningful patent exclusivity or regulatory exclusivity |
The absence of current patent protection does not create a viable generic market by itself. Commercial demand, physician adoption, regulatory status, manufacturing economics, and safety considerations determine whether a discontinued compound can support a new launch.
What is the FDA regulatory status of pargyline hydrochloride?
Pargyline hydrochloride does not have an active U.S. regulatory position comparable to a currently marketed prescription drug. It is not a current standard-of-care treatment for hypertension, and it does not appear to have a current commercial labeling platform supported by an active sponsor.
The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is designed to identify approved prescription drug products and therapeutic-equivalence determinations. A discontinued historical drug may have appeared in earlier regulatory records without representing an active commercial opportunity today.[2]
No current Orange Book-based competitive market can be identified for pargyline hydrochloride. The absence of an active listing or active marketed product is more important commercially than the existence of historical approval records.
What is the Orange Book status of pargyline hydrochloride?
Pargyline hydrochloride has no apparent current Orange Book market comparable to active products with listed patents, exclusivities, and marketed reference products. No active Orange Book patent dispute, current reference-listed-drug strategy, or commercial Paragraph IV campaign is associated with the compound.
Historical approval does not establish current substitutability. A new sponsor seeking to commercialize pargyline hydrochloride would need to determine whether an existing FDA regulatory pathway remains available, whether a reference product exists, and whether the product would require a new drug application or another regulatory strategy.
Are there Paragraph IV challenges involving pargyline hydrochloride?
No active or commercially significant Paragraph IV challenge involving pargyline hydrochloride is publicly apparent.
Paragraph IV litigation requires a generic applicant to challenge listed patents for an active reference product. Pargyline hydrochloride does not have a current branded market with an identifiable active patent estate. That eliminates the normal economic basis for a Paragraph IV filing.
| Litigation issue | Current assessment |
|---|---|
| Active listed patent | None of commercial significance identified |
| Current reference product | No active U.S. branded market identified |
| Paragraph IV notice | No material current activity identified |
| ANDA litigation | No material current activity identified |
| Settlement agreement | No material current settlement identified |
What patents protect pargyline hydrochloride?
No current patent estate of commercial significance protects the historical pargyline hydrochloride product.
Potential historical protection categories would have included:
- Composition-of-matter patents covering pargyline or related compounds.
- Salt-form protection covering pargyline hydrochloride.
- Tablet or dosage-form claims.
- Method-of-use claims for hypertension.
- Manufacturing claims involving synthesis, purification, or salt formation.
Those categories do not create current exclusivity. Any historical patents would have expired, and no current formulation or method-of-use portfolio is publicly associated with an active sponsor.
Are formulation patents relevant to pargyline hydrochloride?
Formulation patents are unlikely to create a meaningful barrier. Pargyline hydrochloride was historically administered in conventional oral dosage forms rather than through a complex delivery system. There is no recognized current long-acting injectable, transdermal, controlled-release, inhaled, or device-based pargyline product generating formulation-based exclusivity.
A new formulation could theoretically receive patent protection if it satisfied novelty, non-obviousness, written-description, and enablement requirements. That would not restore the commercial position of the historical product without clinical and regulatory support.
How strong is the patent estate for pargyline hydrochloride?
The current patent estate is commercially weak to nonexistent.
| Patent-estate factor | Assessment |
|---|---|
| Core compound patent | Expired |
| Salt patent | No current commercial protection identified |
| Formulation patent | No active marketed formulation identified |
| Method-of-use patent | No active commercially relevant claim identified |
| Manufacturing patent | No current barrier identified |
| Patent-term extension | Not commercially relevant |
| Regulatory exclusivity | None identified |
| Freedom-to-operate risk | Likely low for expired historical technology, subject to jurisdiction-specific review |
The principal barriers are regulatory and commercial rather than intellectual-property based. A sponsor would face the cost of establishing product quality, clinical utility, labeling, pharmacovigilance, and reliable manufacturing for an obsolete antihypertensive mechanism.
What is the financial trajectory for pargyline hydrochloride?
The financial trajectory is a decline from historical product revenue to negligible or zero current branded revenue.
No reliable public source reports current sales, operating profit, market share, or forecast revenue for pargyline hydrochloride. The product predates modern public pharmaceutical-product reporting practices, and historical sales were not separately disclosed in a manner that supports a defensible revenue series.
Financial trajectory
| Phase | Financial position |
|---|---|
| Historical launch | Revenue generated through branded antihypertensive sales |
| Expansion period | Limited by adverse-effect burden and competition from newer therapies |
| Mature period | Demand contracted as safer and more effective alternatives gained adoption |
| Discontinuation period | Product revenue declined toward immaterial levels |
| Current period | No verified commercial revenue base |
Pargyline’s commercial decline was driven by therapeutic substitution. Irreversible monoamine oxidase inhibition creates dietary and drug-interaction restrictions and can produce clinically significant adverse effects. Those limitations reduced its attractiveness for chronic hypertension compared with later therapies.
No public company currently identifies pargyline hydrochloride as a material revenue contributor. Revenue exposure for large pharmaceutical companies is therefore effectively zero. Any residual demand would likely arise from research use, historical pharmacology work, or highly limited special-access or compounding activity rather than a conventional prescription market.
Which companies are challenging or commercializing pargyline hydrochloride?
No current major pharmaceutical company is publicly identified as commercializing or challenging pargyline hydrochloride in the United States.
The historical commercial association is with Abbott Laboratories through Eutonyl-era marketing. That historical association does not establish a current Abbott product, active license, or continuing revenue stream.
| Company or group | Current relationship |
|---|---|
| Abbott Laboratories | Historical commercial association; no current marketed product identified |
| Generic manufacturers | No significant current commercial activity identified |
| Specialty pharmaceutical companies | No material current development program identified |
| Compounding pharmacies | Possible limited activity cannot be quantified from public market data |
| Research suppliers | Potential non-therapeutic supply, distinct from an FDA-approved commercial product |
What generic launch risks exist for pargyline hydrochloride?
A generic launch would face low patent risk but high commercial and regulatory risk.
The main risks are:
- No established prescription demand.
- No active reference product supporting a conventional generic strategy.
- Potential need to recreate historical regulatory documentation.
- Limited physician willingness to prescribe an irreversible monoamine oxidase inhibitor for hypertension.
- Safety monitoring and drug-interaction concerns.
- Small manufacturing scale and weak pricing power.
- Competition from inexpensive, widely available antihypertensive drugs.
- Potential difficulty establishing a profitable distribution channel.
A low-cost active ingredient does not solve those problems. Manufacturing pargyline hydrochloride may be technically feasible, but commercial manufacturing requires validated specifications, impurity controls, stability data, qualified suppliers, and a viable regulatory dossier.
What manufacturing and intellectual-property barriers affect the product?
Manufacturing barriers are moderate from a technical perspective and high from a commercial perspective.
The active pharmaceutical ingredient is an older small molecule rather than a biologic or complex peptide. It does not face biosimilar development risk, cold-chain requirements, or device-specific barriers. The relevant technical issues would include synthetic-route control, salt formation, impurity characterization, residual-solvent limits, stability, and dosage-form validation.
The absence of complex IP does not guarantee supply. A sponsor would still need current good manufacturing practice compliance, analytical methods, qualified raw materials, and sufficient demand to support production.
How does pargyline hydrochloride compare with modern antihypertensive drugs?
Pargyline is commercially disadvantaged against every major first-line antihypertensive class.
| Factor | Pargyline hydrochloride | Modern antihypertensive drugs |
|---|---|---|
| Mechanism | Irreversible MAO inhibition | Multiple validated mechanisms |
| Current guideline role | None | Established first-line and add-on roles |
| Safety profile | Significant interaction and dietary concerns | Generally more manageable |
| Generic availability | No meaningful active market | Broad generic supply |
| Physician adoption | Minimal | High |
| Patent opportunity | Expired historical technology | Product- and formulation-specific |
| Revenue potential | Negligible | Varies from mature generic to blockbuster brand |
Pargyline also has no biosimilar market because it is a small-molecule drug, not a biologic. Its competitive threat comes from generic substitution and therapeutic substitution, not biosimilar entry.
What litigation and settlement activity affects pargyline hydrochloride?
No material current patent litigation or settlement activity is associated with pargyline hydrochloride. There is no identified active dispute involving Orange Book patents, Paragraph IV certifications, formulation claims, licensing rights, or market-entry timing.
The lack of litigation reflects the product’s commercial inactivity rather than strong patent protection.
Key Takeaways
- Pargyline hydrochloride is a discontinued historical antihypertensive associated with Eutonyl.
- The compound has no meaningful current U.S. branded market or reported revenue stream.
- Historical composition, formulation, and method-of-use protection has no current commercial force.
- No active Paragraph IV campaign, Orange Book dispute, or patent settlement is identified.
- Biosimilar risk is not applicable because pargyline is a small molecule.
- The main obstacles to re-commercialization are regulatory validation, safety concerns, weak demand, and competition from inexpensive modern antihypertensives.
- Current financial exposure for major pharmaceutical companies appears negligible.
- Any residual activity is more likely to involve research supply or limited special-access use than a conventional prescription market.
FAQs About Pargyline Hydrochloride
Is pargyline hydrochloride still prescribed for hypertension?
Pargyline hydrochloride is not a standard current treatment for hypertension. Modern guidelines favor drugs with stronger clinical evidence, broader use, and more manageable safety profiles.
Is pargyline hydrochloride available as a generic?
No meaningful active U.S. generic market is publicly identifiable. Historical availability does not establish current commercial supply or FDA-supported generic substitution.
Does pargyline hydrochloride have an active patent?
No active patent of material commercial significance is publicly associated with the historical product. Any original compound and product patents would have expired.
Can pargyline hydrochloride be revived as an orphan drug?
Hypertension is a common disease and would not ordinarily support orphan-drug designation. A different rare-disease indication would require new clinical evidence and a separate regulatory strategy.
Is pargyline hydrochloride useful in pharmaceutical research?
Pargyline can remain relevant as a pharmacological research tool because it inhibits monoamine oxidase. Research relevance does not create a viable therapeutic market or indicate current FDA approval for clinical use.
References
- National Center for Biotechnology Information. (n.d.). Pargyline hydrochloride. PubChem Compound Summary. https://pubchem.ncbi.nlm.nih.gov/
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
- U.S. Food and Drug Administration. (n.d.). Discontinued drug product list. https://www.fda.gov/drugs/drug-approvals-and-databases/discontinued-drug-product-list
- National Library of Medicine. (n.d.). DailyMed: Pargyline hydrochloride drug information. https://dailymed.nlm.nih.gov/
- World Health Organization. (2021). WHO guideline for the pharmacological treatment of hypertension in adults. World Health Organization.
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