Ramipril - Generic Drug Details

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

Ramipril is the generic ingredient in three branded drugs marketed by King Pharms Llc, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Cipla, Corepharma, Hikma, Lupin, Ranbaxy Labs Ltd, Senores Pharms, Teva Pharms, Watson Labs, Zydus Pharms Usa, Rosemont Pharms, King Pfizer, Apotex, Natco Pharma, and Zydus Pharms Usa Inc, and is included in twenty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ramipril has three patent family members in two countries.

There are nineteen drug master file entries for ramipril. Seventeen suppliers are listed for this compound.

Summary for ramipril

International Patents:	3
US Patents:	1
Tradenames:	3
Applicants:	20
NDAs:	20
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	177
Patent Applications:	7,524
Drug Prices:	Drug price trends for ramipril
Drug Sales Revenues:	Drug sales revenues for ramipril
What excipients (inactive ingredients) are in ramipril?	ramipril excipients list
DailyMed Link:	ramipril at DailyMed

See drug prices for ramipril

See drug sales revenues for ramipril

Recent Clinical Trials for ramipril

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

Sponsor	Phase
Abant Izzet Baysal University	NA
Evi Liliek Wulandari	PHASE4
The University of Hong Kong	PHASE4

See all ramipril clinical trials

Pharmacology for ramipril

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for ramipril

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for ramipril

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for ramipril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Senores Pharms	RAMIPRIL	ramipril	CAPSULE;ORAL	078191-002	Jun 18, 2008	AB	RX	No	No
Apotex	RAMIPRIL	ramipril	TABLET;ORAL	091069-002	Dec 2, 2015		DISCN	No	No
Actavis Elizabeth	RAMIPRIL	ramipril	CAPSULE;ORAL	077513-004	Jun 18, 2008		DISCN	No	No
Chartwell Rx	RAMIPRIL	ramipril	CAPSULE;ORAL	077514-002	Jun 18, 2008		DISCN	No	No

Expired US Patents for ramipril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007	7,368,469
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991	5,403,856
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991	5,403,856
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007	5,061,722

International Patents for ramipril

Country	Patent Number	Title	Estimated Expiration
United Kingdom	202103724
World Intellectual Property Organization (WIPO)	2020039262
United Kingdom	2591389

Supplementary Protection Certificates for ramipril

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0265685	99C0001	Belgium		PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919

RAMIPRIL: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What does the RAMIPRIL commercial market look like by regulatory reality?

Ramipril is an ACE inhibitor with a long commercial history and broad global availability, which makes pricing and margins primarily a function of generic competition, tendering, and national reimbursement rules rather than ongoing patent-led exclusivity.

Regulatory status (commercial implication)

• Originator era has ended in most major markets, leaving the market to generic manufacturers.
• Brand-to-generic transition is typically mature, so growth is driven by population needs, hypertension prevalence, and formulary placement, not by new molecular innovation.

What the market structure means for pricing

• Generic-heavy supply compresses ex-manufacturer pricing.
• Tender and reimbursement controls dominate retail outcomes.
• Competitive intensity is driven by:
  • availability of multiple ANDA/MAH supply chains,
  • ability to pass quality and bioequivalence requirements at low cost,
  • national prescribing habits and local formulary rules.

How does ramipril demand typically evolve in key therapeutic demand drivers?

Ramipril is used across chronic cardiovascular indications where adherence and long-term treatment persistence matter.

Main demand drivers

• Hypertension management: long-duration therapy supports baseline demand.
• Cardiovascular risk reduction: persistent patient pools from chronic disease and comorbidity management.
• Post-event treatment in appropriate labeled settings increases stickiness because discontinuation rates are low under guideline-driven care.

Demand elasticity and mix shifts

• Low price elasticity in chronic use: patients and clinicians typically accept switch-to-generic once tolerated.
• Mix shifts occur between:
  • single-drug ACE inhibitors and fixed-dose combinations,
  • ACE inhibitors versus ARBs in markets with higher ARB penetration.
• Ramipril tends to maintain share where it is embedded in long-standing guideline regimens and stable formularies.

What does pricing pressure look like over time for ramipril?

For older ACE inhibitors, the pricing trajectory is shaped by stepwise generic entry rather than continuous erosion from a single event.

Typical financial pattern after generic entry

• Initial generic entry creates a rapid price drop from brand pricing to low-cost generic levels.
• Subsequent entries usually reduce prices further but at a slower rate as the market approaches a lower cost floor tied to:
  • manufacturing scale,
  • API sourcing costs,
  • logistics and tender pricing dynamics,
  • regulatory compliance costs.

Profit model under generic competition

• Sustained profitability depends on:
  • scale manufacturing and stable API supply,
  • tight cost structure and tender wins,
  • minimal formulation differentiation risk (few meaningful product differentiators beyond bioequivalence, packaging, and supply reliability).

How does financial trajectory differ by business type: originator vs generics vs combination brands?

Ramipril’s financial story is mostly a story of business model, not molecule growth.

Originator P&L trajectory (brand)

• Post exclusivity end typically means:
  • share loss to generics,
  • gross margin compression,
  • brand shrink unless the originator maintains defensive pricing in high-retention segments.
• Revenues track prescriptions and remaining brand share rather than unit growth in the molecule overall.

Generic manufacturers (core driver of current economics)

• Revenue grows with:
  • volume capture in tenders and formularies,
  • ability to supply consistently.
• Margin depends on:
  • API cost, batch yield, and fixed cost absorption,
  • tender pricing and contract duration.

Combination strategy (fixed-dose positioning)

• Where regulators and clinicians prefer fixed-dose combinations, ramipril can shift from standalone to combo products.
• Financial trajectory then depends on:
  • the combo’s ability to win formulary placement,
  • competitive combination ecosystems from multiple ACE inhibitor partners.

What is the likely trajectory for RAMIPRIL revenues and margins in the near-to-mid term?

Given the molecule’s maturity and broad generic availability, near-to-mid-term dynamics are typically characterized by:

• stable-to-slow revenue growth tied to underlying cardiovascular prevalence and adherence,
• continued margin compression where new entrants or aggressive tenders occur,
• offset from volume retention as switching stabilizes.

Revenue trajectory (directional)

• Volume: generally stable with growth tied to demographics and treatment rates.
• Value: can be pressured where payer systems push lowest-price supply.
• Share: shifts among generic suppliers based on tender cycles and supply continuity.

Margin trajectory (directional)

• Gross margin: pressured by price competition and API volatility.
• Operating margin: increasingly dependent on scale and manufacturing efficiency.
• Risk: disruptions in API supply can briefly improve prices for compliant suppliers, but the effect typically fades as alternative sources enter.

How do tenders, reimbursement, and switching policies drive quarter-by-quarter outcomes?

For mature ACE inhibitors, the main financial variability is operational and payer-driven.

Key levers

• Hospital and national tenders
  • winners can lock in volume for months to a year,
  • losers can experience sharp revenue declines even with stable underlying demand.
• Reimbursement rules
  • reference pricing and substitution policies determine retail and payer reimbursement.
• Switching behavior
  • once patients stabilize, switching is less frequent unless mandated by payer policy.

What financial analysts should watch

• tender award timing and contract expiries,
• supplier qualification changes,
• reference price updates,
• wholesale inventory cycles around contract changes.

What competitive landscape factors shape market share for ramipril tablets/capsules?

Competition is not only about price; it also includes quality, supply reliability, and packaging.

Market-share determinants

• Bioequivalence compliance and regulatory track record
• Supply reliability during tight tender timelines
• Manufacturing capacity and API sourcing resilience
• Packaging and labeling suitability for local formularies and substitution rules

Differentiation limits

• In a generic-heavy market, differentiation is mostly procedural:
  • availability,
  • stability and quality,
  • logistics,
  • documentation strength.

What macro and healthcare-policy factors can alter the financial trajectory?

Ramipril’s usage depends on cardiovascular care delivery and drug-policy enforcement.

Macro factors

• demographic growth in treated populations,
• changes in hypertension detection and treatment rates,
• economic pressure increasing payer sensitivity to lowest-cost options.

Policy factors

• generic substitution enforcement,
• price renegotiations,
• inclusion/exclusion in reimbursement lists,
• procurement reforms favoring multi-supplier tenders or sole-source contracts.

What does this imply for investment or R&D strategy tied to RAMIPRIL?

Ramipril’s commercial economics typically reward:

• supply-scale businesses,
• manufacturers with reliable API procurement,
• firms positioned to win tender-driven volume.

Where value can be created

• Manufacturing efficiency and cost absorption at high batch volumes.
• Geographic portfolio across multiple tender regimes to smooth revenue variability.
• Combination or lifecycle stewardship if the firm controls an in-formulary combination portfolio.

Where value leakage tends to occur

• reliance on single-country tender dependence,
• exposure to API supply constraints without alternative sourcing,
• pricing sensitivity without scale cost advantages.

Key Takeaways

• Ramipril is a mature, generic-dominated ACE inhibitor, so market dynamics are shaped by tendering, reimbursement, and substitution rather than patent exclusivity.
• Demand is structurally supported by chronic hypertension and cardiovascular risk reduction, producing relatively stable volume outcomes.
• Financial trajectory is dominated by pricing pressure, with margins determined by manufacturing scale, API cost control, and contract wins.
• Near-to-mid-term value growth is constrained; variability shows up in supplier-specific revenue swings around tenders and reference price updates.
• Strategic advantage concentrates in supply-scale and payer-facing execution, not in molecule-level differentiation.

FAQs

1. Is ramipril still growing as a molecule overall?
   Typically yes in volume terms via population and treatment-rate dynamics, but value growth is limited by generic pricing and payer reference pricing.

2. What drives quarterly results for ramipril generic suppliers?
   Tender outcomes, contract renewals, reference price updates, and supply continuity.

3. Does ramipril benefit from fixed-dose combinations?
   In markets where combinations are preferred, ramipril often shifts from standalone to combo demand, changing unit economics and formulary exposure.

4. What is the main margin risk for ramipril manufacturers?
   Continued price erosion from competitive entry and aggressive tenders, amplified by API or manufacturing cost volatility.

5. Is R&D the primary value lever for ramipril now?
   Not usually. In mature ACE inhibitor classes, execution advantages in manufacturing, compliance, and procurement tend to matter more than molecule innovation.

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References

[1] World Health Organization (WHO). WHO Model List of Essential Medicines. (Most recent edition accessible via WHO).