RENAGEL Drug Patent Profile

When do Renagel patents expire, and what generic alternatives are available?

Renagel is a drug marketed by Genzyme and is included in two NDAs.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renagel

A generic version of RENAGEL was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8^th, 2019.

Summary for RENAGEL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	19
Drug Prices:	Drug price information for RENAGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RENAGEL
What excipients (inactive ingredients) are in RENAGEL?	RENAGEL excipients list
DailyMed Link:	RENAGEL at DailyMed

See drug prices for RENAGEL

See drug sales revenues for RENAGEL

Recent Clinical Trials for RENAGEL

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

Sponsor	Phase
Shire	Phase 4
Medical Universtity of Lodz	Phase 4
Medical University of Lodz	Phase 4

See all RENAGEL clinical trials

Paragraph IV (Patent) Challenges for RENAGEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RENAGEL	Tablets	sevelamer hydrochloride	400 mg and 800 mg	021179	1	2008-05-22

US Patents and Regulatory Information for RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	AB	RX	Yes	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	AB	RX	Yes	Yes

Expired US Patents for RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000

EU/EMA Drug Approvals for RENAGEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Tasermity	sevelamer hydrochloride	EMEA/H/C/003968Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.,	Withdrawn	no	no	no	2015-02-25

International Patents for RENAGEL

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

Country	Patent Number	Title	Estimated Expiration
Austria	204756
Austria	324900
Australia	5974296
Australia	689797
Australia	7560794

Supplementary Protection Certificates for RENAGEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	CA 2002 00003	Denmark
0716606	SPC/GB02/011 200210	United Kingdom
0716606	SPC004/2002	Ireland		SPC004/2002, 20040614, EXPIRES: 20150127
0716606	C00716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606	CA 2009 00048	Denmark

Last updated: June 13, 2026

Renagel (sevelamer) market dynamics and financial trajectory: sales trends, exclusivity timeline, generic/biosimilar threat, and patent-driven risks

Renagel (sevelamer hydrochloride) has transitioned from a late-2000s brand-growth story to a largely mature, pricing-pressured market as payer formularies tightened and generic sevelamer products expanded. The competitive landscape is now dominated by generic sevelamer salts and ongoing share shifts between sevelamer hydrochloride and sevelamer carbonate brands/generics, with key revenue exposure driven by dialysis-market penetration, tablet dosing economics, and formulary preferences.

What is Renagel (sevelamer hydrochloride) and where does it compete financially?

Renagel is a non-calcium, phosphate binder used in chronic kidney disease (CKD) patients, primarily dialysis patients, to control hyperphosphatemia. Financial trajectory is tied to:

• Dialysis cohort size and growth (US Medicare mix plus international reimbursement).
• Phosphate binder preference by nephrology and payers, including restrictions on calcium-based binders.
• Willingness to pay for non-calcium binders versus generic cost anchors.

Commercial role vs. competitors

• Renagel competes in the phosphate binder class against:
  • Sevelamer carbonate products (brand and generics)
  • Lanthanum carbonate
  • Calcium-based binders
  • Iron-based phosphate binders (market-adjacent, varying by geography and label scope)

Featured snippet: primary drivers of Renagel revenue

• Dialysis patient volume, binder formulary placement, and the spread between brand and generic pricing for sevelamer salts.

How has Renagel sales trended over time versus sevelamer carbonate and generics?

Market dynamic that explains the financial shift Renagel’s brand economics compressed after generic entry of sevelamer hydrochloride and tightening of pharmacy benefit managers’ (PBMs) cost controls. Since phosphate binders are chronic, long-duration therapies, even modest per-patient price declines can drive sizable revenue compression when multiplied across large dialysis populations.

Competitive substitution pattern

• Patients and formularies have shifted between sevelamer salts based on:
  • Price and rebate structures
  • Pill burden and dosing conversions (mg-to-mg equivalence differs by salt form)
  • Prescriber familiarity and local protocols
• Sevelamer hydrochloride brands tend to face faster share pressure once generic alternatives become entrenched and pharmacy pricing benchmarks reset.

What patent estate issues determine Renagel’s generic entry risk?

Renagel’s long-run market dynamics are dominated by sevelamer patent expiry and Paragraph IV outcomes tied to FDA ANDA approvals for sevelamer hydrochloride generics. Once ANDA pathways are available and litigation is settled or dismissed, the sales impact is immediate due to payer switching.

High-level patent-lifecycle logic

1. Orange Book listings for Renagel include drug substance and formulation/therapeutic method protections.
2. Patent expirations are followed by ANDA generic launches once regulatory exclusivities and litigation barriers clear.
3. Subsequent filings often focus on formulation strengths, dosing regimens, and manufacturing method adjustments that attempt to re-position around residual exclusivities.

Featured snippet: what matters most to generic timing

• Whether an ANDA challenger successfully avoids triggering a stay under Hatch-Waxman and whether any later-expiring patents remain listed and enforceable for the specific listed drug strength.

When does Renagel lose regulatory exclusivity and listed patent protection?

A full exclusivity-by-date map requires Orange Book patent-by-patent listing data for Renagel (drug, NDA number, and each listed patent’s expiration date), plus any pediatric exclusivity and marketing exclusivity terms. Without the Orange Book listing table and NDA identifier for Renagel in the provided materials, a complete and accurate exclusivity timeline cannot be produced.

Which companies are the key generic entrants that pressured Renagel revenue?

Renagel’s financial trajectory is shaped by the breadth of ANDA competition for sevelamer hydrochloride once patent barriers declined. The market typically moves quickly from:

• Limited generic assortment at launch
• Rapid price benchmark resets
• Broad PBM preferred status for lowest-net-cost products

However, naming specific generic manufacturers and mapping their entry dates requires Orange Book ANDA details (ANDA numbers, approval dates, and launch timing) and associated litigation dockets. The input provided does not include those data, so identifying the specific challengers would risk error.

What Paragraph IV litigation impacted Renagel’s timing of generic launches?

Paragraph IV litigation timing is a key determinant of when generics can launch and therefore when Renagel brand sales steeply decline. To quantify impact, one needs:

• Identified Orange Book patents asserted in each case
• Court filings and stays
• Settlement agreements and consent decrees
• Post-judgment scope and any “carve-out” around strengths/dosage forms

No case list, docket numbers, or settlement records are included in the supplied material, so a litigation-driven launch schedule cannot be stated accurately.

What is the Orange Book status of Renagel and how many patents remain listed?

Orange Book status is determined by:

• NDA number for Renagel
• Number of listed patents
• Patent-by-patent status (active vs expired)
• Any blocking patents that delay generic entry

Without the Orange Book listing dataset for Renagel, including patent numbers and expiration dates, the count and status cannot be provided correctly.

How does Renagel compare with sevelamer carbonate products on commercial outcomes?

Competitive economics

• Sevelamer salts sit in a payer-cost and formulary arbitration layer where the “best value” product often wins share after generic penetration.
• If sevelamer carbonate has stronger brand positioning or better rebate structures, it can displace sevelamer hydrochloride within the same therapeutic class.

Practical purchase drivers

• Net price after rebates and PBM contracting
• Tablet size and dosing frequency (tolerability affects adherence and continuation)
• Substitution tolerance between salts under nephrology protocols

What formulation and manufacturing patents affect Renagel supply and market competition?

Formulation and manufacturing method patents can affect:

• The availability of certain strengths
• Stability and bioequivalence pathways
• Plant qualification timelines
• Ability to launch at scale

Accurate mapping requires:

• Listed formulation/manufacturing patents for Renagel
• Patent claims scope and any invalidation outcomes
• ANDA manufacturing-site approvals and any supply constraints

These are not available in the provided information, so a precise barrier analysis cannot be produced.

What generic entry risks exist for Renagel by strength, route, and dosing form?

Renagel is oral and tablet-based. Risk is primarily:

• Continued exposure to additional ANDA filings (strength-specific approvals)
• Potential “late” launch of products that were previously blocked by particular patents

Strength-level launch risk requires the full strength list tied to Orange Book entries and each ANDA’s approval/marketing date, which is not provided.

How do FDA pathway decisions influence Renagel market dynamics?

Once generic products are approved via ANDA routes, FDA pathway decisions typically determine:

• The ability to file (and whether a patent list blocks approval timing)
• Label equivalence and substitutability
• Any relevant exclusivities that delay final approval

For Renagel, pathway impacts are dominated by ANDA approval timing and any 30-month stay effects from Paragraph IV.

No FDA approval timelines or exclusivity terms are supplied, preventing an accurate regulatory chronology.

What is the current competitive landscape for non-calcium phosphate binders impacting Renagel?

Beyond sevelamer salts, competitive pressure comes from the broader phosphate binder market:

• Lanthanum carbonate often competes on tolerability and dosing convenience in some markets
• Calcium binders compete on cost but face payer pushback tied to safety concerns
• Newer agents can alter formulary mix depending on guideline alignment and payer coverage

Renagel’s revenue exposure depends on whether payers shift toward alternatives that offer better cost-effectiveness on their preferred formularies.

How strong is the patent estate for Renagel versus generic substitutes?

Patent strength for a legacy brand like Renagel is measured by:

• How many active blocking patents remain for each listed strength
• Whether patents are formulation-limited or broadly cover composition and method
• Prior court outcomes narrowing enforceability

A quantified strength score requires patent-by-patent status and litigation outcomes. Those data are not included.

What settlement agreements or licensing deals changed Renagel revenue outcomes?

Licensing and settlements can:

• Set launch dates
• Limit product configurations
• Allocate market entry between challengers
• Trigger supply or distribution restrictions

No settlement or license terms are included, so this cannot be addressed with accuracy.

Renagel revenue exposure: what levers drive profit and loss in the mature brand phase?

Even after generic entry, the remaining revenue and margin profile can be affected by:

• Continued patient base retention through prescriber inertia and tolerance
• PBM rebate competitiveness for remaining covered uses
• Switching dynamics in dialysis networks
• Mix shift across geographies and payer segments

Where generic penetration is broad and sustained, net brand revenue usually falls toward low levels unless the company retains meaningful pricing leverage.

Key Takeaways

• Renagel’s market dynamics are governed by chronic phosphate binder demand and the speed of generic substitution once patent barriers clear.
• Financial trajectory has likely shifted from brand growth to mature, rebate- and formulary-driven revenue stabilization after generic entry.
• The decisive determinants of the timing and magnitude of revenue compression are Orange Book patent expirations and any Paragraph IV litigation or settlements tied to sevelamer hydrochloride strengths.
• A strength-and-timeline assessment requires the Renagel NDA Orange Book listing, including patent numbers, expiration dates, and litigation docket outcomes; those data are not present here.

FAQs

1. Why do phosphate binder revenues decline faster than many other chronic drugs after generic entry?
   Because PBM preferred status and net-price contracting can move quickly to lowest-cost equivalents, and switching is common in dialysis networks.

2. Does sevelamer hydrochloride compete more directly with carbonate or with other phosphate binders?
   Primarily with sevelamer salts in formulary negotiations, then secondarily versus lanthanum and calcium-based options depending on payer policy.

3. What evidence typically determines payer formulary replacement of Renagel with sevelamer generics?
   Net pricing after rebates, substitution rules, and guideline alignment for non-calcium binders.

4. How do dialysis population trends affect Renagel demand even during heavy generic competition?
   Demand can remain stable in volume terms, but brand revenue usually declines as price per day falls with competitive contracting.

5. What typifies launch timing for ANDA sevelamer hydrochloride products?
   Launch schedules are typically driven by Hatch-Waxman stays, Orange Book blocking patents, and final settlement or judgment outcomes tied to specific listed patents and strengths.

References (APA)

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. FDA. “Hatch-Waxman Act and Paragraph IV Certifications.” U.S. Food and Drug Administration.