FOSRENOL Drug Patent Profile

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

Fosrenol is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifteen patent family members in eight countries.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fosrenol

A generic version of FOSRENOL was approved as lanthanum carbonate by NATCO PHARMA LTD on August 11^th, 2017.

Summary for FOSRENOL

International Patents:	15
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	27
Drug Prices:	Drug price information for FOSRENOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSRENOL
What excipients (inactive ingredients) are in FOSRENOL?	FOSRENOL excipients list
DailyMed Link:	FOSRENOL at DailyMed

See drug prices for FOSRENOL

Recent Clinical Trials for FOSRENOL

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

Sponsor	Phase
Medical University of Lodz	Phase 4
Medical Universtity of Lodz	Phase 4
Universitair Ziekenhuis Brussel	Phase 3

See all FOSRENOL clinical trials

Pharmacology for FOSRENOL

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for FOSRENOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSRENOL	Oral Powder	lanthanum carbonate	750 mg and 1000 mg	204734	1	2015-11-25
FOSRENOL	Chewable Tablet	lanthanum carbonate	500 mg, 750 mg and 1000 mg	021468	3	2008-10-27

US Patents and Regulatory Information for FOSRENOL

FOSRENOL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes	8,980,327		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	AB	RX	Yes	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No	8,980,327		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No

Expired US Patents for FOSRENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	7,465,465
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	7,381,428
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014	5,968,976

International Patents for FOSRENOL

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

Country	Patent Number	Title	Estimated Expiration
Austria	209923
Australia	4951496
Australia	702073
Brazil	9607926

Supplementary Protection Certificates for FOSRENOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817639	SPC/GB06/036	United Kingdom		SPC/GB06/036: 20061027
0817639	PA2008005	Lithuania		PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
0817639	PA2008005,C0817639	Lithuania		PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029

FOSRENOL (lanthanum carbonate): Market dynamics, pricing trajectory, and financial outlook

Last updated: July 23, 2026

FOSRENOL (lanthanum carbonate) remains a long-cycle phosphate binder with limited therapeutic switching once patients are stabilized, but its growth is constrained by (1) competitive displacement by newer binders, (2) payer-driven preference shifts based on total cost of therapy, and (3) the slowing of incident dialysis populations in mature markets. Financial trajectory is driven less by innovation and more by chronic-treatment dynamics, contracted pricing, and life-cycle management around product forms and dose strengths.

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What is FOSRENOL’s market position in phosphate binders for dialysis patients?

FOSRENOL is positioned in the chronic kidney disease (CKD) and end-stage renal disease (ESRD) space as a non-calcium, non-aluminum phosphate binder. Its commercial base is anchored in stable patients who are clinically tolerant to lanthanum carbonate and who remain on binder therapy long term.

Which phosphate binder competitors most affect FOSRENOL demand?

FOSRENOL competes primarily against:

• Sevelamer (sevelamer carbonate, sevelamer hydrochloride; polymeric binder)
• Calcium-based binders (binder options that often win on short-term cost but carry calcium exposure considerations)
• Iron-based binders (where available and clinically adopted by payers/clinicians)
• Other emerging/region-specific phosphate binders that expand formularies

Market share pressure typically comes from payer formularies and nephrology practice patterns that emphasize lower-cost agents or simplified regimens.

How do reimbursement and formulary decisions shape phosphate binder market dynamics?

In dialysis, phosphate binder selection is heavily payer-influenced:

• Coverage tiers and prior authorization thresholds favor binders with demonstrated affordability and formulary placement.
• Health plans increasingly use net price and member cost-sharing to influence choice.
• Pharmacy benefit managers optimize for drug acquisition cost plus administration logistics, even when clinical differences are modest at the patient level.

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When did FOSRENOL peak commercially, and what does the revenue curve typically look like?

FOSRENOL’s commercial trajectory follows the classic pattern of a mature, off-patent small molecule in a chronic category:

• Peak adoption phase in early years as CKD/ESRD phosphate binder use expanded.
• Later plateau as competitors gained share through formulary conversions.
• Steady decline or near-flat revenue in mature markets depending on contract renegotiations and uptake of preferred binder classes.

What typically drives revenue changes for mature phosphate binders like FOSRENOL?

Key drivers:

• Dialysis prevalence and incidence (patient population growth is slow in many mature geographies)
• Payer net pricing (rebates, discounts, and contract resets)
• Switching rates due to GI tolerability or binder burden
• Persistence once patients are stable on a regimen

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What factors limit growth for FOSRENOL in 2024–2029?

Growth headwinds dominate because FOSRENOL is already a widely used option and new uptake requires payer and clinician buy-in.

Are pill burden and dosing convenience a competitive lever?

Phosphate binders must be taken with meals, and binder load can be clinically and behaviorally limiting:

• Therapies with lower pill burden or more favorable taste/administration profiles can win in formulary evaluations.
• Any differences in tolerability can increase switching risk for newly treated patients, even if stable patients persist.

How does patient adherence affect long-term financial performance?

In chronic CKD, adherence is a high-leverage variable:

• Missed doses reduce phosphate control and can lead to regimen changes.
• Clinician responses to lab trends can trigger switches, especially for patients initiating therapy.

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What pricing and contract dynamics most influence FOSRENOL’s net sales?

FOSRENOL’s revenue outcome is usually tied to net price rather than list price.

What do net price pressure cycles look like for off-patent brands?

Common patterns for a mature brand:

• Contract resets after competitive formulary actions.
• Increased rebate pressure when payers seek parity across classes.
• Price adjustments tied to volume commitments.

How do pharmacy benefit vs medical benefit structures affect realized revenue?

For dialysis-related chronic medications, commercial payers and integrated delivery systems often negotiate via PBM channels. Realized revenue depends on:

• Rebate terms and patient access programs
• Inclusion in preferred drug lists
• Requirements around step therapy or prior authorization

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What is the FDA status and how does that influence commercialization?

FOSRENOL is an FDA-approved phosphate binder. Its regulatory status affects manufacturing and distribution but does not create growth optionality like new exclusivity regimes.

How does regulatory maturity affect market expansion opportunities?

Without new indications or exclusivity-driven barriers to generic entry, market expansion depends on:

• New patient starts through payer formularies
• Product form optimization
• Contracting strategy and patient support programs

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Does generic competition exist for FOSRENOL, and what is the impact risk?

For a mature small molecule phosphate binder, generic or authorized generic pressure typically determines long-run brand economics. As an off-exclusivity asset, FOSRENOL’s financial trajectory is exposed to:

• Direct generic substitution for equivalent therapy
• Authorized generic presence through branded channel strategies
• Payer switching to lowest net-cost alternatives

What financial impacts follow generic penetration in a chronic binder market?

When generic penetration increases:

• Brand net sales decline faster than patient incidence can offset
• Margin compresses via rebate acceleration and formulary design
• Manufacturing scale shifts toward maintaining distribution footprint rather than growing volume

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What patent estate factors matter for FOSRENOL’s financial trajectory?

FOSRENOL’s lifecycle is dominated by whether any late-cycle patent protections affect generic market entry timing, including:

• Formulation patents (e.g., composition and dosage form)
• Method-of-use or patient population claims (binder use in CKD/ESRD)
• Process/manufacturing patents
• Pediatric exclusivity or other regulatory exclusivities (where applicable)

In practice, financial outcomes in mature phosphate binders track closeness of remaining IP barriers to generic entry and the extent of successful litigation or settlements.

How does ongoing IP affect settlement dynamics and brand pricing power?

If any barriers remain, brand economics can hold longer via:

• Reduced intensity of generics seeking entry
• Settlements that delay launches
• Contracting leverage tied to launch timing

If barriers are exhausted, pricing power typically fades quickly with net-price competition.

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What litigation or Paragraph IV dynamics typically govern FOSRENOL competition?

For long-established products like FOSRENOL, any generic challengers and patent holders generally follow a standard pattern:

• Patent certification under FDA’s Orange Book framework
• District court infringement proceedings
• Potential settlement agreements that align with launch timing and design-around constraints

How do settlements translate into financial results for the brand?

Settlements can cause:

• Step-changes in revenue at launch delay milestones
• Short-term stabilization during negotiated entry windows
• Discontinuous margin compression post-launch

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How does FOSRENOL compare with sevelamer and calcium-based binders on commercial dynamics?

Why do payers shift between binder classes even when clinical guidelines are similar?

Commercial switching happens because payers prioritize:

• Total cost of therapy (drug acquisition plus expected persistence)
• Patient-specific tolerability and lab outcomes that reduce downstream costs
• Simplified formulary placement

Where does FOSRENOL tend to sit in payer formularies?

FOSRENOL typically competes for:

• Non-calcium binder preferred positions, where clinicians want to avoid calcium exposure
• Patients who fail or do not tolerate alternatives

If a payer adopts a dominant binder strategy, FOSRENOL’s growth depends on exception rates and clinical adherence.

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What manufacturing and supply-chain factors affect FOSRENOL availability and sales?

Mature brands can be affected by:

• Scale economics and batch availability
• Contract manufacturing capacity
• Distribution agreements with wholesalers and specialty pharmacy channels

Supply continuity usually matters more for erosion prevention than for growth.

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How do dialysis market trends and geographic mix influence FOSRENOL’s financial trajectory?

What dialysis demographics matter for binder demand?

Binder consumption tracks dialysis prevalence and the number of phosphate measurements and regimen adjustments. The key constraints:

• Slower population growth in mature markets
• Higher replacement and maintenance intensity as dialysis duration increases

How does international commercialization differ from US economics for phosphate binders?

International pricing and access differ due to:

• Tender systems and national formularies
• Patent and regulatory timelines across jurisdictions
• Competitor entry sequences

Financial performance can diverge by region even when the underlying molecule is the same.

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Revenue and margin outlook: what matters most for investors and licensors

For FOSRENOL, the financial trajectory is usually determined by:

1. Patient retention and persistence (how many stable patients remain)
2. Net price after rebate pressure (contracting and PBM actions)
3. Generic substitution rate (how quickly lowest-cost alternatives win)
4. Formulary positioning (preferred vs restricted tier status)
5. Exclusion/inclusion in dialysis bundle frameworks (where applicable)

Scenario table: financial drivers under different market conditions

Scenario	Assumptions	Likely sales direction	Likely margin direction
Preferred non-calcium position holds	Limited formulary erosion; switch exceptions maintained	Flat to modest decline	Stable to slight compression
Net price resets tighten	PBM converts to lower-cost binder	Decline accelerates	Rebate and discount intensity rises
Generic/authorized generic penetration increases	Expanded coverage for alternatives at lower net cost	Material decline	Sharp margin compression
Clinical switching increases	Tolerability or adherence shifts drive regimen changes	Downtrend across new starts	Erosion across both volume and net price

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Key Takeaways

• FOSRENOL competes in a mature, chronic phosphate binder category where formularies and net price dominate.
• Growth is constrained by slow market expansion and by payer switching toward lower-cost or preferred binder classes.
• Financial trajectory is most sensitive to net pricing, persistence among stable patients, and substitution rates once generic/authorized generic pressure increases.
• Any remaining IP or litigation leverage can delay specific generic entry waves, but absent new exclusivity, long-run economics trend toward continued erosion.

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FAQs

1) What drives phosphate binder switching in dialysis patients from a commercial perspective?
Formulary tier changes, net-price contracting via PBMs, prior authorization outcomes, and adherence/tolerability effects that trigger regimen changes.

2) How does net pricing typically impact mature off-patent brands like FOSRENOL?
Net sales decline can outpace patient-volume changes as rebate intensity and discounting increase after competitor formulary adoption.

3) What is the main commercial risk for FOSRENOL if generics expand coverage?
Faster volume erosion as payers steer new starts to lower-cost alternatives and stable patients may switch under lab-driven clinician or payer pressure.

4) Does product form or dosing convenience affect payer behavior?
Yes. Convenience impacts adherence and physician willingness to switch, which affects persistence and formulary inclusion for chronic use.

5) How does regional reimbursement structure change the financial outcome for phosphate binders?
Tendering, national formularies, and PBM versus direct procurement models can delay or accelerate generic substitution and reshape net pricing differently by country.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Labeling for FOSRENOL (lanthanum carbonate). U.S. Food and Drug Administration.

DrugChatter Q&A for FOSRENOL

When does the fosrenol patent expire in the us?
Does medicare cover fosrenol?