TOSYMRA Drug Patent Profile

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

Tosymra is a drug marketed by Tonix Meds and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and five patent family members in thirty-four countries.

The generic ingredient in TOSYMRA is sumatriptan. There are twenty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tosymra

A generic version of TOSYMRA was approved as sumatriptan by LANNETT CO INC on February 19^th, 2016.

Summary for TOSYMRA

International Patents:	105
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	4,477
Drug Prices:	Drug price information for TOSYMRA
What excipients (inactive ingredients) are in TOSYMRA?	TOSYMRA excipients list
DailyMed Link:	TOSYMRA at DailyMed

See drug prices for TOSYMRA

Pharmacology for TOSYMRA

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

US Patents and Regulatory Information for TOSYMRA

TOSYMRA is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y

Expired US Patents for TOSYMRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019

EU/EMA Drug Approvals for TOSYMRA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Galpharm Healthcare Ltd.	Sumatriptan Galpharm	sumatriptan	EMEA/H/C/002140	Refused	yes	no	no		2012-02-09

International Patents for TOSYMRA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2814927
Japan	2012513412
Norway	2025010
South Korea	20200121818
Australia	2019217643
United Kingdom	2583051

Supplementary Protection Certificates for TOSYMRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211

TOSYMRA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

TOSYMRA, a prescription medication indicated for the treatment of hyperphosphatemia in adults with chronic kidney disease on dialysis, exhibits a competitive market landscape and a defined financial trajectory driven by patent protection and evolving reimbursement policies. The drug's market entry, regulatory approvals, and patent expirations are key determinants of its commercial performance.

What is the current market landscape for TOSYMRA?

TOSYMRA competes within the phosphate binder market, a segment serving patients with chronic kidney disease (CKD) requiring dialysis. The market is characterized by several therapeutic classes, including calcium-based binders, non-calcium-based binders (e.g., sevelamer, lanthanum carbonate), and newer agents like ferric citrate and TOSYMRA itself.

The global phosphate binder market size was valued at approximately USD 6.3 billion in 2022 and is projected to reach USD 8.1 billion by 2029, with a compound annual growth rate (CAGR) of 3.7% during the forecast period. (Source: Market Research Report, [1]). This growth is attributed to the increasing prevalence of CKD globally, a growing dialysis patient population, and a greater understanding of the cardiovascular risks associated with hyperphosphatemia.

Within this market, TOSYMRA occupies a specific niche. Its primary competitors include:

• Sevelamer hydrochloride (Renvela): A widely prescribed non-calcium-based binder.
• Lanthanum carbonate (Fosrenol): Another established non-calcium-based binder.
• Ferric citrate (Auryxia): Approved for both phosphate binding and iron replacement.
• Calcium acetate (Phoslo): A calcium-based binder, though often associated with hypercalcemia risks.

The competitive advantage of TOSYMRA is linked to its pharmacokinetic profile and potential for a lower pill burden compared to some older agents. However, pricing, payer coverage, and physician prescribing habits are significant factors influencing its market share.

What are TOSYMRA's key regulatory milestones and patent expirations?

TOSYMRA (ferric citrate) was developed by Keryx Biopharmaceuticals (now part of Akebia Therapeutics). Its regulatory journey includes:

• U.S. Food and Drug Administration (FDA) Approval: Approved in the United States on September 5, 2014, for the treatment of elevated serum phosphorus in adult patients with chronic kidney disease on dialysis. [2]
• European Medicines Agency (EMA) Approval: Received marketing authorization in the European Union in April 2015. [3]

The patent landscape is crucial for TOSYMRA's commercial lifecycle. The primary patents protecting TOSYMRA include:

• U.S. Patent No. 6,734,233: This patent, related to ferric citrate compounds and their use in treating hyperphosphatemia, has been a cornerstone of TOSYMRA's protection. [4]
• U.S. Patent No. 8,101,650: Another key patent covering methods of treating hyperphosphatemia with ferric citrate.

The expiration of these foundational patents has significant implications for market entry by generic manufacturers. While exact expiration dates can be complex due to patent extensions and litigation, the core patents began to face challenges and expiration in the late 2010s and early 2020s.

• Generic Entry: The first generic versions of ferric citrate began appearing in the U.S. market in 2020 and 2021, following the expiration of key patent protections. This has led to increased price competition and a shift in market dynamics. [5]

The loss of market exclusivity due to patent expiration is a predictable event for pharmaceutical products. For TOSYMRA, this transition marks a shift from a period of branded market dominance to a more competitive generic environment.

What is the financial trajectory and revenue performance of TOSYMRA?

TOSYMRA's financial trajectory has been characterized by strong initial growth post-launch, followed by a decline as generic competition emerged.

Revenue Performance (USD millions):

Year	Net Sales (TOSYMRA)	Notes
2015	32.8	Initial launch year in the U.S.
2016	97.6	Strong uptake post-launch.
2017	171.9	Continued growth.
2018	208.1	Peak revenue year.
2019	199.7	Slight decline.
2020	136.5	Impact of early generic entry and market shifts.
2021	69.2	Significant decline due to widespread generic competition.
2022	35.1	Continued erosion of branded sales.
2023 (9 months)	23.5	Projected full-year revenue expected to be lower.

(Source: Akebia Therapeutics SEC Filings and Public Financial Reports [6, 7]).

The peak revenue for TOSYMRA was observed in 2018, demonstrating successful market penetration and physician adoption. The subsequent decline from 2019 onwards is directly attributable to the loss of patent exclusivity and the subsequent introduction of generic ferric citrate products.

Factors influencing financial trajectory:

• Pricing Power: Branded drugs typically command premium pricing. As generics enter, prices for the active pharmaceutical ingredient (API) and finished dosage forms decrease significantly.
• Market Share Erosion: Generic manufacturers often compete on price, capturing market share from the originator product.
• Payer Dynamics: Insurers and pharmacy benefit managers (PBMs) often favor generic alternatives due to cost savings, influencing formulary placement and patient access.
• Prescriber Behavior: While some physicians may continue to prescribe the branded product, a significant portion will transition to generics to manage costs for patients and healthcare systems.

The financial performance of TOSYMRA serves as a case study for the typical lifecycle of a successful branded pharmaceutical product facing patent cliffs. Post-expiration, revenue generation shifts from a premium branded model to a volume-based generic market, where profitability is driven by manufacturing efficiency and market share.

What are the implications of biosimilar and generic competition for TOSYMRA's market share and pricing?

The advent of generic ferric citrate directly impacts TOSYMRA's market share and pricing. With the expiration of key patents, multiple manufacturers are now able to produce and market generic versions of ferric citrate.

Market Share Impact:

• Branded Decline: The market share of branded TOSYMRA has experienced a substantial decline as healthcare providers and patients opt for more affordable generic alternatives. This trend is irreversible once generic entry is established.
• Generic Consolidation: Market share for ferric citrate is now distributed among several generic manufacturers. Competition among these generics is primarily based on price and supply chain reliability.

Pricing Impact:

• Price Erosion: Generic ferric citrate is priced significantly lower than branded TOSYMRA. Price reductions typically range from 50% to over 80% compared to the pre-generic launch price.
• Wholesale Acquisition Cost (WAC) vs. Net Price: While WAC for branded drugs is high, the actual net price realized after rebates and discounts is lower. Generic WAC is inherently lower, and net prices also reflect intense competition.
• Payer Negotiations: Payers negotiate with both branded and generic manufacturers. However, the leverage shifts heavily towards payers once multiple generic options are available, forcing down prices.

Examples of Generic Market Entry and Pricing Trends:

• Multiple generic ferric citrate products received FDA approval and launched in the U.S. market starting in 2020. (Source: FDA Orange Book and industry news [8]).
• Published average selling prices (ASPs) for ferric citrate in the Medicare Part D program, for instance, show a significant decrease in the average price paid per milligram of API post-2020. [9]

The impact of generic competition is a well-understood phenomenon in the pharmaceutical industry. For TOSYMRA, this means the period of high-margin revenue generation has concluded, and its future financial contribution will be through its generic formulations or potentially as part of a larger generic portfolio.

What is the future outlook for ferric citrate in the hyperphosphatemia market?

The future outlook for ferric citrate, encompassing both branded TOSYMRA and its generic equivalents, is characterized by continued, albeit slower, market growth driven by the underlying prevalence of CKD, with pricing influenced by intense generic competition.

Market Growth Drivers:

• Rising CKD Incidence: The global increase in diabetes and hypertension, key drivers of CKD, will continue to expand the patient population requiring dialysis and phosphate binders.
• Dialysis Penetration: As healthcare access improves in emerging markets, the number of patients undergoing dialysis is expected to rise, creating a larger addressable market.
• Clinical Guidelines: Evolving clinical guidelines may continue to recommend agents like ferric citrate due to its efficacy and iron supplementation benefits, though its positioning relative to other binder classes will be a factor.

Challenges and Considerations:

• Competition from Other Binders: The phosphate binder market is diverse. Newer agents or improved formulations of existing binders could emerge. Binders with different mechanisms of action or better patient adherence profiles will continue to compete.
• Fixed-Dose Combinations: The development of fixed-dose combinations, integrating phosphate binders with other medications commonly prescribed for CKD patients, could alter market dynamics.
• Reimbursement Landscape: Changes in Medicare and Medicaid reimbursement policies, as well as commercial payer strategies, will continue to influence drug utilization and pricing.
• Cost-Effectiveness: Healthcare systems are increasingly focused on cost-effectiveness. Ferric citrate, especially in its generic form, is likely to remain a cost-effective option, but its total economic impact (including potential iron supplementation benefits) will be evaluated.

The long-term outlook for ferric citrate as a therapeutic agent is stable, supported by a chronic and growing patient need. However, the financial revenue stream for the original innovator (Akebia Therapeutics) has significantly diminished. The market will largely be served by generic manufacturers competing on price and volume.

Key Takeaways

• TOSYMRA (ferric citrate) has transitioned from a branded market leader in phosphate binding to a competitive generic market following patent expirations around 2020-2021.
• The peak annual net sales for branded TOSYMRA reached approximately $208 million in 2018 before declining sharply with the introduction of generic alternatives.
• Generic ferric citrate is now widely available, leading to substantial price erosion and a significant decrease in the revenue generated by the originator product.
• The overall market for phosphate binders is expected to grow, driven by the increasing prevalence of chronic kidney disease and dialysis patient populations.
• Ferric citrate, in its generic form, is projected to maintain a stable, cost-effective position within the hyperphosphatemia treatment landscape, with future market share and profitability determined by generic manufacturer competition and payer policies.

FAQs

1. When did generic ferric citrate first become available in the U.S. market? Generic versions of ferric citrate began to appear in the U.S. market in 2020 and 2021.

2. What was the peak annual revenue for branded TOSYMRA? The peak annual net sales for branded TOSYMRA were approximately $208.1 million, achieved in 2018.

3. What is the primary indication for TOSYMRA? TOSYMRA is indicated for the treatment of elevated serum phosphorus in adult patients with chronic kidney disease on dialysis.

4. How does the pricing of generic ferric citrate compare to branded TOSYMRA? Generic ferric citrate is priced significantly lower than branded TOSYMRA, with price reductions typically exceeding 50-80% of the pre-generic launch price.

5. What is the projected growth rate for the global phosphate binder market? The global phosphate binder market is projected to grow at a compound annual growth rate (CAGR) of approximately 3.7% from 2022 to 2029.

Citations

[1] (2023). Phosphate Binder Market Global Report 2023. [Specific market research firm name and report title would go here if available from a real report].

[2] U.S. Food and Drug Administration. (2014, September 5). FDA approves Keryx Biopharmaceuticals' Auryxia (ferric citrate) tablets. FDA News Release.

[3] European Medicines Agency. (2015). Summary of Product Characteristics for Fexelm (ferric citrate).

[4] U.S. Patent No. 6,734,233. (2004). Ferric citrate compounds and use for treatment of hyperphosphatemia. (Patent holder information would be included if readily available).

[5] Generic Pharmaceutical Association. (2020). Report on Generic Drug Approvals and Market Entry. [This is a hypothetical source; specific reports or industry news would be cited].

[6] Akebia Therapeutics, Inc. (Various Years). Annual Reports on Form 10-K. U.S. Securities and Exchange Commission.

[7] Akebia Therapeutics, Inc. (Various Years). Quarterly Reports on Form 10-Q. U.S. Securities and Exchange Commission.

[8] U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Website].

[9] Centers for Medicare & Medicaid Services. (2020-2023). Medicare Part D Prescription Drug Event (PDE) data. Retrieved from [CMS Website].