RANEXA Drug Patent Profile

Which patents cover Ranexa, and what generic alternatives are available?

Ranexa is a drug marketed by Menarini Intl and is included in one NDA.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ranexa

A generic version of RANEXA was approved as ranolazine by CHARTWELL RX on July 29^th, 2013.

Summary for RANEXA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	47
Patent Applications:	3,442
Drug Prices:	Drug price information for RANEXA
What excipients (inactive ingredients) are in RANEXA?	RANEXA excipients list
DailyMed Link:	RANEXA at DailyMed

See drug prices for RANEXA

See drug sales revenues for RANEXA

Recent Clinical Trials for RANEXA

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

Sponsor	Phase
Haisco Pharmaceutical Group Co., Ltd.	PHASE1
Policlinico Universitario Agostino Gemelli	Phase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 4

See all RANEXA clinical trials

Paragraph IV (Patent) Challenges for RANEXA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RANEXA	Extended-release	ranolazine	500 mg and 1000 mg	021526	1	2010-05-17

US Patents and Regulatory Information for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007		DISCN	Yes	No
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006		DISCN	Yes	No

Expired US Patents for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007

EU/EMA Drug Approvals for RANEXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A. (MIOL)	Ranexa (previously Latixa)	ranolazine	EMEA/H/C/000805Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,	Authorised	no	no	no	2008-07-08

International Patents for RANEXA

See the table below for patents covering RANEXA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	31533
Australia	2834684
Australia	566489
Brazil	1100474
Canada	1256874	ARYLOXY ET ARYLTHIO- HYDROXYPROPYLPIPERAZINYLACETANILIDES CARDIOSELECTIFS QUI MODIFIENT L'ENTREE DE CALCIUM (CARDIOSELECTIVE ARYLOXY AND ARYLTHIO-HYDROXYPROPYL PIPERAZINYL ACETANILIDES WHICH AFFECT CALCIUM ENTRY)

Supplementary Protection Certificates for RANEXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	PA2008017	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558	CA 2008 00051	Denmark		PRODUCT NAME: RANOLAZIN ELLER ET SALT DERAF
1109558	91504	Luxembourg		91504, EXPIRES: 20230709
1109558	PA2008017,C1109558	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714

Last updated: June 24, 2026

RANEXA (ranolazine) market dynamics and financial trajectory: pricing, demand drivers, competition, and exclusivity risk

Executive summary: RANEXA (ranolazine) revenue has been structurally pressured by sustained generic competition and limited new-cycle expansion since originator exclusivity fell away. Market dynamics are now dominated by class substitution inside antianginal therapy, payer-driven formulary placement, and channel-level volume shifts rather than new patient starts. Financial trajectory in the public record is best described as plateau-to-decline with quarter-to-quarter volatility tied to wholesaler inventory patterns and contracting. Patent and regulatory risk is no longer centered on first-time generic entry, shifting instead to line extensions, formulation durability, and geographic carve-outs.

What is RANEXA (ranolazine) used for and how does that shape demand?

Featured answer: RANEXA is used for chronic angina (including chronic stable angina) to improve exercise tolerance and reduce angina frequency. Demand is tied to chronic disease management and payer acceptance of add-on therapy, not acute-episode utilization.

Indication scope that drives patient selection

• Chronic angina (stable/long-term)
• Role in clinical pathway is commonly add-on after first-line antianginals (beta blockers, calcium channel blockers, nitrates), which limits addressable patient starts versus first-line agents.

How treatment positioning shapes market share

• Payer policies often place ranolazine as non-preferred or preferred only with criteria (baseline angina documentation, intolerance to other drugs, step therapy).
• Because use is add-on, treatment switching (from other add-ons) matters more than therapy initiation.

Clinical and guideline adoption effects

• When guideline emphasis shifts toward other antianginal classes, ranolazine’s incremental growth typically slows.
• Where ranolazine has strongest uptake is in subpopulations treated for persistent symptoms despite standard therapy, which keeps demand more stable but caps top-line expansion.

Which companies sell ranolazine and how does generic substitution affect RANEXA revenue?

Featured answer: Ranolazine’s market is now characterized by multi-source generic supply, with RANEXA-referenced pricing anchored to payer benchmarks and the competitive lowest-cost position rather than originator pricing.

Competition structure

• Originator brand: RANEXA (historically Gilead originator program; ranolazine brand was later associated with other commercial ownership depending on period).
• Generic manufacturers: Multiple ANDA entrants have reduced brand pricing power through wholesale buy-downs and payer substitution.

Market dynamic mechanics

• Generic entry creates:
  • Net price compression via rebate pressure and contracting.
  • Volume reallocation toward lowest-cost SKUs and authorized generics where available.
  • Lower realized revenue per prescription for the brand, even when some patients remain on branded therapy.

Channel and contracting

• Ranolazine is a chronic pill therapy; the contracting environment favors:
  • PBM formulary tier shifts,
  • MAC pricing updates,
  • increased use of quantity limits and prior authorization.

When did RANEXA lose exclusivity and how does that timeline map to financial trajectory?

Featured answer: The financial trajectory has been driven by exclusivity roll-off followed by repeated generic pressure cycles, with early decline after generic availability and later stabilization at reduced brand-level net revenue.

Exclusivity and patent-driven phases (generic-market reality)

• Phase 1: Originator coverage
  • Brand pricing supported by patent-protected compound and initial formulations/methods of use.
• Phase 2: ANDA launch
  • Rapid net revenue drop as prescribers and payers move to lower-cost supply.
• Phase 3: Post-entry stabilization
  • Brand persists for formulary positioning, patient continuity, and prescriber inertia, but revenue remains structurally capped.

Financial pattern expected from the above

• Brand revenue typically shows:
  • a step-down around initial generic availability,
  • subsequent lower plateau with volatility from payer revisions and wholesaler inventory.

How do payers and formularies influence RANEXA prescriptions and net sales?

Featured answer: Payer formulary placement is the principal driver of realized demand for ranolazine due to its add-on role and chronic use.

Typical payer levers

• Step therapy or prior authorization
• Criteria tied to:
  • documented diagnosis of chronic angina,
  • trial/failure or intolerance of other antianginals,
  • adherence to dosing regimen.

Rebate and contracting

• As generics expand, PBMs increase pressure on brand:
  • enhanced rebates to maintain tier status,
  • tighter net price reporting,
  • continued substitution incentives.

Net revenue outcome

• Even with prescription continuity, brand net sales can decline because:
  • the market shifts to generics faster than the brand can defend price.

What is the competitive landscape for ranolazine in antianginal therapy?

Featured answer: Ranolazine competes within a crowded antianginal class ecosystem where functional differentiation is often “add-on symptom control,” which reduces brand differentiation versus other options.

Key therapeutic alternatives

• Beta blockers
• Calcium channel blockers
• Long-acting nitrates
• Other antianginal agents and late-line add-ons depending on region and guideline approach

Competitive implications

• When payers or prescribers favor a different add-on, ranolazine’s incremental prescription growth slows.
• When rebates and access improve for alternatives, substitution accelerates.

How does RANEXA compare with other branded and generic antianginal drugs on revenue resilience?

Featured answer: Ranolazine’s revenue resilience is weaker than first-line antianginal brands due to reliance on add-on use and sustained generic substitution.

Determinants of relative brand survival

• Whether the brand can maintain:
  • preferred formulary tier,
  • favorable patient access criteria,
  • stable net pricing despite generics.

Positioning outcome for RANEXA

• In chronic add-on classes, multi-source competition tends to compress realized net sales more than in first-line therapies.

What patent estate issues matter for RANEXA market protection now?

Featured answer: Current market protection is more likely to be tied to specific formulation, method-of-use, and manufacturing patents rather than ongoing compound exclusivity, because base exclusivity has already lapsed.

Patent categories that influence late-stage protection

• Formulation patents
  • sustained-release, polymorph, specific excipient systems
• Method-of-use patents
  • specific patient subsets, dosing regimens
• Manufacturing-process patents
  • crystallization, solid-state processing controls

Commercial impact of residual patent coverage

• Residual coverage can delay certain ANDA variants or narrow substitution, creating localized revenue pockets.
• However, if therapeutic equivalence and generic approvals cover broad dosing forms, macro-level financial trajectory remains dominated by generics.

Are there Paragraph IV challenges or ANDA litigation affecting ranolazine market timing?

Featured answer: Competitive timing has been dominated by ANDA launches, with any litigation playing a secondary role once multiple generic products exist.

Typical effect on financial trajectory

• When ANDA litigation delays an entrant, the brand may hold a higher net price temporarily.
• Once multiple generics are established, marginal litigation effects diminish.

What is the Orange Book status of ranolazine for RANEXA and how does that translate to generic risk?

Featured answer: Orange Book listings drive the map of remaining listed patents, and the breadth of listed coverage determines whether generic entry faces narrow or broad entry barriers.

How to read Orange Book risk for this product class

• If patents are listed for:
  • the active ingredient only (now expired), generic risk is high and broad.
  • formulations or methods, risk can be narrower and variant-specific.
  • manufacturing steps, risk may shift to process design around the claim.

How do manufacturing/IP barriers affect cost and price erosion in ranolazine?

Featured answer: As generic supply expands, cost barriers shift from IP to scale economics and quality/regulatory execution rather than claim-level protection.

Generic manufacturing dynamics

• Chronic therapies are sensitive to:
  • solid-state quality consistency,
  • dissolution and bioequivalence execution,
  • supply chain reliability.

Price erosion pattern

• With multiple suppliers, competition drives net price toward MAC-level benchmarks.
• Brand sales only retain value if payers keep it preferred via rebate economics.

What is the likely financial trajectory for RANEXA over the next 12 to 36 months?

Featured answer: The most likely trajectory is continued contraction-to-stability at reduced brand-level net sales, with quarterly variability from payer contracting cycles and inventory alignment, rather than major structural upside.

Primary drivers

• Continuation of generic market saturation
• PBM formulary and rebate renegotiations
• Ongoing substitution for add-on therapy when alternative add-ons are favored

Secondary drivers

• Any incremental shift in guideline-driven prescribing patterns
• Inventory normalization events

Key takeaways

• RANEXA demand is tied to chronic angina add-on use, which limits patient-start growth and increases payer leverage.
• Generic substitution is the dominant force shaping net sales, producing structural price compression and a plateau-to-decline trajectory.
• Residual patent and Orange Book coverage, if any, tends to narrow rather than reverse market pressure once multiple generics are established.
• Over the near term, financial performance is most sensitive to payer contracting, rebate economics, and formulary tiering rather than new competitive entries.

FAQs

1. How does prior authorization affect ranolazine (RANEXA) prescription persistence versus generic switches?
2. Which dosing forms of ranolazine tend to retain the largest brand share during generic penetration?
3. What PBM contracting patterns most directly impact RANEXA net prices in chronic cardiovascular therapies?
4. How do residual formulation or method-of-use patents change ANDA launch strategies for ranolazine?
5. What antianginal therapies most frequently substitute for ranolazine in payer-managed care?

References

No sources were provided in the prompt.

DrugChatter Q&A for RANEXA

Does ranexa lower blood pressure?