Rescinnamine - Generic Drug Details

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

Rescinnamine is the generic ingredient in two branded drugs marketed by Panray and Pfizer, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for rescinnamine

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	33
DailyMed Link:	rescinnamine at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for rescinnamine

C02AA	Rauwolfia alkaloids
C02A	ANTIADRENERGIC AGENTS, CENTRALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

US Patents and Regulatory Information for rescinnamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MODERIL	rescinnamine	TABLET;ORAL	010686-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MODERIL	rescinnamine	TABLET;ORAL	010686-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Panray	CINNASIL	rescinnamine	CAPSULE;ORAL	084736-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Rescinnamine Market Dynamics, Patent Status, FDA History, and Financial Trajectory

Last updated: September 3, 2026

Rescinnamine is an obsolete antihypertensive drug with no meaningful current commercial market in the United States. Its market declined after newer ACE inhibitors, calcium-channel blockers, beta blockers, and thiazide-based therapies offered stronger clinical positioning, simpler dosing, and better commercial support. No material active patent estate, Orange Book exclusivity, Paragraph IV activity, biosimilar risk, or visible licensing market remains associated with rescinnamine. Drug-specific revenue data are not publicly reported, but commercial value is effectively negligible.

What is rescinnamine and how does it work?

Rescinnamine is an antihypertensive alkaloid derived from Rauwolfia species. It belongs to the older group of rauwolfia-derived agents used to lower blood pressure. Its pharmacology is associated primarily with depletion of catecholamines and other neurotransmitters from peripheral sympathetic nerve terminals, producing reduced sympathetic tone and lower blood pressure.

Rescinnamine is not the same molecule as modern synthetic ACE inhibitors such as captopril, enalapril, lisinopril, or ramipril. The drug predates the broad clinical adoption of those products and has a less favorable therapeutic profile.

Historical treatment limitations included:

• Slow or variable onset of blood-pressure reduction.
• Central and peripheral adverse effects associated with monoamine depletion.
• Depression and sedation concerns.
• Nasal congestion and gastrointestinal effects.
• Orthostatic hypotension.
• Drug-interaction and tolerability problems.
• Limited suitability for modern combination-treatment protocols.

The clinical category has largely moved from rauwolfia alkaloids to drugs with more predictable pharmacology and stronger cardiovascular-outcomes data. The FDA has described rauwolfia-related products in the context of older antihypertensive therapies rather than current growth products [1].

When did rescinnamine lose exclusivity?

Rescinnamine lost meaningful commercial exclusivity decades ago. The molecule is an old small-molecule active ingredient, and any original composition-of-matter or product patents would have expired long before the modern generic-drug period.

Rescinnamine patent timeline

IP or regulatory issue	Current assessment
Active ingredient patent	No commercially relevant active patent identified
Original product patents	Expired decades ago
Formulation patents	No current commercially material formulation estate identified
Method-of-use patents	No active modern method-of-use estate identified
Patent-term extension	No relevant current extension identified
Orange Book-listed patents	No current commercial protection identified
Pediatric exclusivity	None identified
New chemical entity exclusivity	Expired many decades ago
Regulatory exclusivity	No active exclusivity identified

The age of rescinnamine means the commercial question is no longer patent duration. It is whether any manufacturer has an economic reason to maintain a regulated product, obtain supply, and support distribution.

What is the FDA regulatory status of rescinnamine?

Rescinnamine has no meaningful current FDA commercial position. Historical rescinnamine products were marketed for hypertension, but the drug is not a significant component of the current U.S. antihypertensive market.

The FDA’s Drugs@FDA and Orange Book systems distinguish between active approved products, discontinued products, and historical regulatory records. A discontinued product record does not establish current market availability or current approval for commercial distribution [2][3].

FDA status indicators

FDA issue	Assessment
Current U.S. branded product	No material current product identified
Current generic competition	No active, commercially visible generic market identified
Orange Book relevance	Historical or discontinued-product relevance only
ANDA competition	No significant current ANDA market identified
NDA status	Historical product status; no active growth platform
OTC conversion	No meaningful current OTC franchise identified
Current treatment guideline role	Minimal to none

The absence of an active product does not mean that the molecule has been formally erased from every regulatory database. Older drug records can remain searchable after commercial discontinuation. Regulatory database presence should not be interpreted as evidence of current sales.

What patents protect rescinnamine today?

No active patent estate with material commercial significance is apparent for rescinnamine as an active pharmaceutical ingredient, dosage form, manufacturing process, or therapeutic use.

Composition-of-matter patents

Any original composition protection for rescinnamine would have expired long ago. The molecule was known and used clinically before the current Hatch-Waxman patent framework became the central determinant of small-molecule launch timing.

Formulation patents

No modern formulation platform is associated with rescinnamine. Historical tablets and conventional oral dosage forms would not normally support a durable present-day exclusivity strategy unless a manufacturer developed a genuinely differentiated delivery system and obtained a new patent. No such commercial platform is evident.

Method-of-use patents

No active method-of-use patent portfolio appears to protect rescinnamine for a modern hypertension subpopulation, combination regimen, or secondary indication. The drug’s conventional use in hypertension is well established and would face substantial prior-art barriers to new broad claims.

Manufacturing and process protection

Rescinnamine is a natural-product-derived alkaloid. Manufacturing value could theoretically arise from purification, synthesis, crystallization, or impurity-control processes. No publicly visible current process-IP strategy has created a meaningful market barrier. For an old, low-demand antihypertensive, process development would likely add cost without creating a sufficient price premium.

How many patents cover rescinnamine?

The commercially relevant number is effectively zero. Historical patent records may exist for the molecule, extraction methods, formulations, or early pharmaceutical products, but they do not create current market exclusivity.

A patent-count exercise should separate:

1. Expired historical patents.
2. Abandoned applications.
3. Patents unrelated to the marketed drug.
4. Patents covering a different rauwolfia alkaloid.
5. Active patents with enforceable claims against a current product.

Counting every historical document would overstate rescinnamine’s present IP position.

Which companies marketed rescinnamine?

Rescinnamine was marketed historically by companies associated with older antihypertensive products. Brand and manufacturer records vary by jurisdiction and period, and many historical labels are no longer linked to active commercial portfolios.

The market structure was typical of older prescription drugs:

• Early branded products established clinical awareness.
• Generic or multisource products reduced pricing power.
• Larger cardiovascular companies shifted resources to newer agents.
• Distribution became less attractive as demand contracted.
• Manufacturing and regulatory-maintenance costs eventually outweighed revenue.

No current major pharmaceutical company appears to treat rescinnamine as a strategic cardiovascular asset. There is no visible contemporary originator investment, branded relaunch, specialty-pharmacy strategy, or licensing campaign.

What was the historical market position of rescinnamine?

Rescinnamine competed in an earlier antihypertensive market dominated by rauwolfia alkaloids, diuretics, ganglion-blocking agents, hydralazine, and other older therapies. Its commercial relevance declined as physicians gained access to products with better tolerability, dosing convenience, and clinical evidence.

Competitive displacement

Competitor class	Commercial effect on rescinnamine
Thiazide diuretics	Lower-cost and clinically established alternatives
Beta blockers	Expanded cardiovascular treatment options
ACE inhibitors	Major pharmacologic and commercial displacement
Calcium-channel blockers	Broad use across hypertension subgroups
ARBs	Improved tolerability for renin-angiotensin-system treatment
Fixed-dose combinations	Better adherence and commercial differentiation

ACE inhibitors were particularly important because they offered a new treatment mechanism and became foundational products in hypertension and heart failure. Later, ARBs and modern fixed-dose combinations expanded the competitive gap.

Rescinnamine therefore lost share through therapeutic substitution rather than through a single patent cliff. Its decline reflected cumulative obsolescence.

What is the financial trajectory for rescinnamine?

Rescinnamine has no publicly reported stand-alone revenue trajectory. Public company filings do not identify a material current revenue stream attributable to the drug, and no major company appears to disclose rescinnamine sales as a reportable product line.

Financial trajectory

Period	Market condition	Financial implication
Early commercialization	Prescription antihypertensive use	Revenue generated through branded sales
Generic-era expansion	Multisource competition	Price and margin erosion
ACE-inhibitor adoption	Rapid therapeutic substitution	Volume contraction
Mature decline	Limited physician use	Minimal commercial support
Current period	No material active market	Negligible identifiable revenue

The likely financial path was:

1. Initial revenue from branded prescription sales.
2. Gradual erosion as generic and alternative products expanded.
3. Loss of promotional value after newer antihypertensives became standard.
4. Product discontinuation or near-discontinuation.
5. Residual demand limited to historical prescribing, niche markets, or isolated jurisdictions.

No reliable public basis exists for assigning a current annual revenue estimate. The appropriate commercial conclusion is that rescinnamine has no material standalone investment value as a prescription-drug franchise.

What generic entry risks exist for rescinnamine?

Generic entry risk is no longer the central threat because the market has already passed through the generic-entry phase. Any entrant would face a different risk profile: insufficient demand.

Principal commercial risks

• Low prescription volume.
• Physician unfamiliarity.
• Strong substitution by inexpensive modern therapies.
• Limited reimbursement leverage.
• Difficulty achieving manufacturing scale.
• Regulatory-maintenance costs.
• Supply-chain fragility for an old active ingredient.
• Low probability of meaningful price premium.
• Limited hospital or guideline demand.

A manufacturer could theoretically enter with an approved product if regulatory and supply requirements were satisfied. The commercial launch would still be difficult because an old molecule without exclusivity cannot easily support sales, promotion, or channel investment.

Are there Paragraph IV challenges or generic litigation involving rescinnamine?

No active, commercially material Paragraph IV campaign is associated with rescinnamine. Paragraph IV litigation generally matters when a branded reference drug has unexpired Orange Book patents. Rescinnamine lacks that present-day structure.

Litigation issue	Current assessment
Active Paragraph IV challenge	None of material commercial significance identified
Orange Book patent litigation	None of material commercial significance identified
ANDA injunction risk	No current branded patent estate identified
Hatch-Waxman settlement	No current settlement market identified
Patent-term dispute	No current dispute identified
Antitrust exposure	No contemporary patent-related issue identified

Historical litigation may exist in broader records, but it would not materially affect current entry timing or valuation.

What patent litigation affects rescinnamine?

No current patent litigation materially affects rescinnamine’s commercial status. The principal barrier is market economics, not enforceable intellectual property.

A potential entrant would still need to assess:

• FDA approval requirements.
• Current pharmacopeial standards.
• Active pharmaceutical ingredient sourcing.
• Manufacturing reproducibility.
• Labeling and safety requirements.
• State substitution rules.
• Pharmacovigilance obligations.
• Product-liability exposure.

These factors are regulatory and operational rather than patent-based.

Is rescinnamine exposed to biosimilar competition?

No. Rescinnamine is a chemically defined small molecule, not a biologic. Biosimilar pathways under the Biologics Price Competition and Innovation Act do not apply.

The relevant competitive category is generic small-molecule competition. Even that category is largely theoretical today because current commercial demand is limited.

What licensing deals involve rescinnamine?

No significant current licensing deal involving rescinnamine is publicly visible. The drug has no evident strategic value for major pharmaceutical licensors, specialty generics companies, or platform-technology developers.

A historical license or distribution arrangement may have existed in a particular jurisdiction, but such agreements would not represent a current growth transaction unless tied to an active product, a protected formulation, or a differentiated market. No such transaction is apparent.

How does rescinnamine compare with modern antihypertensive drugs?

Attribute	Rescinnamine	Lisinopril	Losartan	Amlodipine
Drug class	Rauwolfia-derived antihypertensive	ACE inhibitor	ARB	Calcium-channel blocker
Current clinical role	Minimal	Broad	Broad	Broad
Patent position	Expired	Expired for original product	Expired for original product	Expired for original product
Generic availability	Limited or inactive	Extensive	Extensive	Extensive
Commercial demand	Negligible	High-volume generic	High-volume generic	High-volume generic
Modern guideline relevance	Low	High	High	High
Biosimilar exposure	None	None	None	None
Reimbursement position	Weak	Strong generic access	Strong generic access	Strong generic access

The comparison shows why rescinnamine has little residual market value. Its patents are not the only issue. Modern competitors have stronger clinical adoption, broader supply, greater guideline support, and larger established generic markets.

What geographic markets may still have rescinnamine demand?

Any remaining use is likely to be geographically fragmented and difficult to quantify. Older antihypertensive products can persist in selected countries because of historical prescribing patterns, local registration, or availability through small distributors.

No broad multinational commercial strategy is apparent. Geographic risk factors include:

• Country-specific product registrations.
• Local discontinuation dates.
• National formularies.
• Import controls.
• API availability.
• Pharmacopoeial requirements.
• Local substitution practices.
• Informal or nonstandard supply channels.

A historical brand name in a national database does not establish active sales. The strongest conclusion is that any residual demand is niche, nontransparent, and commercially weak.

How strong is the rescinnamine patent estate?

The patent estate is commercially weak to nonexistent. It has no visible active composition, formulation, use, or manufacturing protection capable of supporting premium pricing or deterring generic entry.

The only potentially meaningful barriers are:

1. Regulatory cost relative to demand.
2. API sourcing and quality control.
3. Product liability and safety management.
4. Lack of distribution scale.
5. Physician and payer substitution.

These barriers protect neither a branded franchise nor a durable licensing position. They reduce the attractiveness of entry for all manufacturers.

Key Takeaways

• Rescinnamine is an obsolete rauwolfia-derived antihypertensive.
• Its original exclusivity expired decades ago.
• No meaningful active patent estate, Orange Book protection, or Paragraph IV market is apparent.
• No current biosimilar issue applies because rescinnamine is a small molecule.
• Modern antihypertensive classes displaced it through superior adoption, tolerability, and clinical positioning.
• Current FDA relevance is historical or discontinued-product oriented.
• No material current revenue stream is publicly identifiable.
• Commercial risk is driven by weak demand and operating economics, not patent litigation.
• Any remaining geographic demand is likely fragmented and low value.
• Rescinnamine has negligible standalone investment, licensing, or business-development value.

FAQs

Is rescinnamine still prescribed for high blood pressure?

Rescinnamine is rarely used in contemporary hypertension practice. Modern guidelines and formularies generally favor thiazide diuretics, ACE inhibitors, ARBs, calcium-channel blockers, and other better-established therapies.

Does rescinnamine have an Orange Book patent?

No current commercially meaningful Orange Book patent protection is apparent for rescinnamine. Historical regulatory records should not be treated as evidence of active patent exclusivity.

Can a generic manufacturer launch rescinnamine without patent litigation?

Patent litigation risk appears minimal because no active branded patent estate is evident. The principal launch obstacles are regulatory compliance, supply, demand, and commercial viability.

Is rescinnamine the same as reserpine?

No. Both are rauwolfia-derived alkaloids, but rescinnamine and reserpine are different chemical entities. They have related historical antihypertensive uses but are not interchangeable active ingredients.

Could rescinnamine be revived as a low-cost hypertension drug?

A revival would face weak commercial prospects. Low manufacturing scale, limited guideline support, safety and tolerability concerns, and extensive generic competition from modern antihypertensives would constrain demand.

References

1. U.S. Food and Drug Administration. (2023). Regulatory history and labeling resources for antihypertensive drugs. FDA.

2. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/

4. National Library of Medicine. (2024). Rescinnamine. MedlinePlus and related drug-information resources. https://www.nlm.nih.gov/

5. World Health Organization. (2023). WHO guideline for the pharmacological treatment of hypertension in adults. World Health Organization.