RAYALDEE Drug Patent Profile

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

Rayaldee is a drug marketed by Eirgen and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and ninety-two patent family members in thirty-eight countries.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

DrugPatentWatch^® Generic Entry Outlook for Rayaldee

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RAYALDEE

International Patents:	192
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	1
Patent Applications:	3,441
Drug Prices:	Drug price information for RAYALDEE
What excipients (inactive ingredients) are in RAYALDEE?	RAYALDEE excipients list
DailyMed Link:	RAYALDEE at DailyMed

See drug prices for RAYALDEE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RAYALDEE

NDA:

208010

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RAYALDEE

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

Sponsor	Phase
OPKO Health, Inc.	Phase 2

See all RAYALDEE clinical trials

Pharmacology for RAYALDEE

Drug Class

Vitamin D3 Analog

US Patents and Regulatory Information for RAYALDEE

RAYALDEE is protected by twenty-two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes			Y
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes

Expired US Patents for RAYALDEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016

International Patents for RAYALDEE

When does loss-of-exclusivity occur for RAYALDEE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RAYALDEE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2640094
Canada	2882048
Cyprus	1118017
Cyprus	1125077
Denmark	1993559

Supplementary Protection Certificates for RAYALDEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481400	301085	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
2968172	301095	Netherlands		PRODUCT NAME: CALCIFEDIOL IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; NATIONAL REGISTRATION NO/DATE: 124799 20200922; FIRST REGISTRATION: DE 2202115.00.00 20200819
2968172	CA 2021 00005	Denmark		PRODUCT NAME: CALCIFEDIOL; NAT. REG. NO/DATE: 62564 20200910; FIRST REG. NO/DATE: DE 2202115.00.00 20200818
2481400	122020000079	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; NAT. REGISTRATION NO/DATE: 2202115.00.00 20200818; FIRST REGISTRATION: VEREINIGTES KOENIGREICH GROSSBRITANNIEN UND NORDIRLAND PL 50784/0005 - 0001 20200721

RAYALDEE Market Dynamics and Financial Trajectory (NDA Landscape, Uptake Drivers, Pricing/Access, and Exclusivity-Driven Competition)

Last updated: July 22, 2026

RAYALDEE (calcifediol) has a narrow, vitamin D-directed commercial footprint in the US for patients with hypocalcemia and vitamin D insufficiency in the setting of hypoparathyroidism, and it competes primarily on clinical positioning, payer coverage, and prescriber adoption rather than broad therapeutic-class switching. Near-term revenue trajectory is dominated by (1) payer formulary inclusion for calcifediol vs. high-utility vitamin D alternatives, (2) adherence to the drug’s specific indication logic and dosing, and (3) loss-of-exclusivity and “at-risk” generic entry dynamics tied to Orange Book-listed patents and any regulatory exclusivities.

What is RAYALDEE and what market does it target?

Featured snippet answer: RAYALDEE is an oral calcifediol product used for vitamin D deficiency states where clinicians seek faster 25(OH)D replenishment than traditional cholecalciferol in appropriate patient populations; US commercialization is shaped by payer policies for vitamin D therapy and by prescriber comfort with the calcifediol dosing model.

Therapeutic category and clinical positioning

• Active ingredient: calcifediol (25-hydroxyvitamin D3).
• Mechanistic rationale: calcifediol bypasses the hepatic 25-hydroxylation step needed for cholecalciferol, which can matter in patients with impaired vitamin D conversion or where rapid correction is prioritized.
• Market pull: clinicians typically weigh calcifediol against cholecalciferol, calcitriol, and ergocalciferol based on speed of repletion, monitoring burden, and hypocalcemia risk.

Where demand concentrates

• Demand concentrates in endocrinology and specialty care (hypoparathyroidism-related hypocalcemia management and related vitamin D correction strategies).
• Sales depend on test-and-treat behavior: frequency of 25(OH)D and calcium monitoring and how quickly results trigger dose changes.

Who markets RAYALDEE and what is the likely revenue structure?

Featured snippet answer: Revenue is primarily US prescription revenue, with channel inventory effects and contract pharmacy dynamics affecting quarterly timing.

Commercial channels that typically shape calcifediol uptake

• Endocrinology practices and clinics using structured lab monitoring.
• Specialty pharmacies if contracting moves the product into restricted distribution.
• PBM formulary design around “vitamin D agents” where step edits can apply.

Pricing and access mechanics that drive trajectory

• RAYALDEE’s financial trajectory is sensitive to:
  • Net price changes from PBM rebates and managed-care contracting.
  • Prior authorization or step therapy for “vitamin D deficiency” diagnosis codes.
  • Specialty tier placement vs. broad over-the-counter vitamin D coverage (OTC cholecalciferol competes on accessibility, not necessarily on clinical framing).

What patents protect RAYALDEE and how strong is the patent estate?

Featured snippet answer: The strength and timing of RAYALDEE’s patent estate are determined by the Orange Book listing(s) for approved calcifediol strengths and any method-of-use, formulation, or dosing regimen patents tied to the approved NDA.

Patent estate components to evaluate (market impact drivers)

• Drug substance and composition patents (calcifediol composition, polymorph/solid-state if applicable).
• Formulation patents (oral dosage form, release profile, excipients).
• Method-of-use patents (specific patient populations, monitoring and dosing logic).
• Orange Book coverage affects generic timing, not clinical substitution patterns alone.

Exclusivity vs. patents

• FDA exclusivity (if applicable to the NDA) can add a regulatory barrier independent of patents.
• Patent expiry triggers manufacturing and approval planning for generics and “authorized” entrants.

When does RAYALDEE lose exclusivity and how does that affect competition?

Featured snippet answer: The competitive inflection point is the earlier of (a) patent expiration for Orange Book-listed claims that read on the approved product and (b) any FDA exclusivity that bars approval. After that window, generic entry risk rises and pricing pressure typically follows.

Timeline sensitivity

• Generic launch typically targets the “first legally marketed” date created by patent/ exclusivity status.
• Any litigation settlement can shift launch dates by months to years, often through agreed carve-outs.

Market behavior after patent loss

• Expect net price compression before volume shifts fully: PBMs accelerate substitution once an AB-rated generic becomes available.
• Patient retention depends on tolerability and the stability of lab monitoring protocols after switching.

What is the Orange Book status of RAYALDEE?

Featured snippet answer: Orange Book status determines whether RAYALDEE has remaining listed patents for the approved NDA and which claims a potential ANDA filer must challenge via Paragraph IV.

What to extract from Orange Book for investment or licensing

• Number of listed patents by type: composition, formulation, and method-of-use.
• Expiration dates for each patent.
• Whether any are tied to specific strengths or dosage forms.
• Whether there are unexpired patents likely to block generic approval unless successfully litigated.

Have any generics been challenged via Paragraph IV for RAYALDEE?

Featured snippet answer: Paragraph IV activity is the leading indicator for imminent generic entry risk and can trigger settlement-based delayed launches.

How Paragraph IV affects market dynamics

• A Paragraph IV challenge can generate:
  • 30-month stay of approval (if triggered).
  • Incentives for settlement with branded sponsor.
  • Higher launch risk for “at-risk” marketing after legal outcomes.

Settlement-driven revenue impact

• Settlements often define:
  • Launch month/year.
  • Authorized generic terms.
  • Carve-out products, label limitations, or distribution constraints.

Is RAYALDEE at risk from reformulations, authorized generics, or follow-on products?

Featured snippet answer: Beyond pure generics, the main brand erosion risks are label expansions, reformulations, and authorized generics that preserve shelf occupancy while reducing net pricing.

Follow-on product patterns in vitamin D markets

• Strength/label variations can change patent mapping and payer preference.
• Authorized generics can be used to maintain physician familiarity while reducing reimbursement cost.

How does RAYALDEE compare with key alternatives on commercial and clinical drivers?

Featured snippet answer: RAYALDEE competes with cholecalciferol and ergocalciferol products (availability and OTC access) and calcitriol products (active vitamin D with stronger potency but different monitoring and tolerability considerations).

Competitive comparison factors

• Speed of correction (calcifediol vs cholecalciferol).
• Monitoring intensity and hypercalcemia risk management.
• Payer preference for cost-minimization vs clinical outcomes.
• Patient adherence driven by dosing frequency and test schedules.

What litigation affects RAYALDEE generic entry timing?

Featured snippet answer: Litigation affects market entry timing through automatic stays, injunction risks, settlement delays, and final court interpretation of patent claim scope.

Litigation mechanisms that matter financially

• Claim construction outcomes can narrow what a generic must prove.
• Summary judgment or appellate outcomes can shorten or extend generic launch windows.
• Injunctions can force “design-around” changes, driving launch delay or labeling constraints.

What FDA regulatory pathway dynamics govern RAYALDEE commercialization barriers?

Featured snippet answer: For a non-innovator to launch, ANDA and Orange Book patent status control timing. For any biosimilar-like pathway, it is unlikely because calcifediol is a small molecule, so the primary pathway risk is ANDA.

Regulatory bottlenecks affecting commercial timing

• Exclusivity and patent listings constrain approval timing even with ready manufacturing.
• Label matching requires bioequivalence and content uniformity for generics.
• Any pediatric exclusivity extension, if present, can further shift effective dates.

What market access patterns drive RAYALDEE sales volume vs. price?

Featured snippet answer: In vitamin D categories, net revenue is typically a function of payer policy intensity and lab monitoring protocols, meaning volume depends on adherence and test frequency while price depends on PBM contracting and generic availability.

Access levers

• Prior authorization criteria tied to diagnosis codes and lab thresholds.
• Quantity limits influenced by typical titration schedules.
• Patient copay design and manufacturer support programs (if used) affecting adherence.

Contract pharmacy and channel mix

• Channel mix shifts can change quarter-to-quarter revenue recognition and inventory levels.
• Rebate restructuring in response to formulary changes can alter net-to-gross economics.

How will generic launch scenarios play out for RAYALDEE?

Featured snippet answer: The most likely scenario post-exclusivity is a phased erosion pattern: delayed launch for patents in dispute, then steep net price compression as PBMs switch to lower-cost equivalents and as physicians standardize monitoring and dosing after the first substitutions.

Generic launch scenario matrix

• Scenario A: Clean launch at first possible date
  • Rapid AB substitution once coverage updates.
  • Net price falls within 1-2 quarters.
• Scenario B: Settlement-delayed launch
  • Brand retains market share longer, with payer contracting adjusting more slowly.
  • Net price compression begins closer to launch date.
• Scenario C: Protracted litigation
  • Brand holds exclusivity longer, with incremental competition via smaller volume or “authorized generic” if settlement includes it.
  • Greater volatility in quarterly revenue from expectation shifts.

What commercial metrics best track RAYALDEE financial trajectory?

Featured snippet answer: Track prescriptions, net sales net of rebates, and payer coverage indicators rather than only gross list price. Volume is especially sensitive to specialty prescribing cycles and lab monitoring behavior.

Key KPI checklist

• US prescriptions and TRx growth vs. vitamin D class growth.
• Net sales margin (net of PBM rebates and discounts).
• Coverage: number of covered lives, specialty tier placement changes.
• Claims trend: proportion of covered claims requiring prior authorization.
• Channel inventory: wholesaler buy-in for quarter-end timing.

Key Takeaways

• RAYALDEE’s financial trajectory is driven by payer formulary access, the specialty test-and-treat workflow, and substitution resistance tied to clinical comfort with calcifediol dosing.
• The dominant competitive risk is Orange Book-governed generic entry timing plus litigation-driven stays or settlements.
• Post-exclusivity, the category’s typical economics imply rapid net price compression once AB-rated alternatives land, with volume erosion following coverage and physician standardization.
• Near-term revenue durability is most sensitive to formulary stability and any Paragraph IV-driven entry timeline signals.

FAQs

1. How do prior authorization policies for vitamin D therapies typically influence RAYALDEE net sales?
2. What Orange Book patent types (composition, formulation, method-of-use) are most likely to delay RAYALDEE generic approval?
3. Do settlements in calcifediol ANDA disputes usually include authorized-generic provisions, and how does that affect brand revenue?
4. How does calcifediol’s clinical repletion profile influence payer acceptance versus cholecalciferol?
5. What prescription and claims metrics should be monitored to forecast RAYALDEE volume changes ahead of generic entry?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. FDA Guidance and resources on ANDA submissions and Paragraph IV patent certifications.
3. Public FDA labeling and prescribing information for RAYALDEE (calcifediol).

DrugChatter Q&A for RAYALDEE

What is rayaldee used for?
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