NASCOBAL Drug Patent Profile

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

Nascobal is a drug marketed by Endo Operations and is included in two NDAs.

The generic ingredient in NASCOBAL is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nascobal

A generic version of NASCOBAL was approved as cyanocobalamin by PADAGIS ISRAEL on September 9^th, 2020.

Summary for NASCOBAL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Drug Prices:	Drug price information for NASCOBAL
Drug Sales Revenues:	Drug sales revenues for NASCOBAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASCOBAL
What excipients (inactive ingredients) are in NASCOBAL?	NASCOBAL excipients list
DailyMed Link:	NASCOBAL at DailyMed

See drug prices for NASCOBAL

See drug sales revenues for NASCOBAL

Recent Clinical Trials for NASCOBAL

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

Sponsor	Phase
Swedish Orphan Biovitrum	Phase 1

See all NASCOBAL clinical trials

Pharmacology for NASCOBAL

Drug Class

Vitamin B12

Paragraph IV (Patent) Challenges for NASCOBAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASCOBAL	Nasal Spray	cyanocobalamin	500 mcg/spray	021642	1	2017-04-28

US Patents and Regulatory Information for NASCOBAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996		DISCN	No	No
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No

Expired US Patents for NASCOBAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005

International Patents for NASCOBAL

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

Country	Patent Number	Title	Estimated Expiration
Austria	54254
Australia	5775786
Australia	584703
Canada	1300014	COMPOSITIONS NASAUX CONTENANT LA VITAMINE B (NASAL COMPOSITIONS CONTAINING VITAMIN B)
Germany	3672430

Nascobal (nasal calcitonin) market dynamics and financial trajectory: sales trends, exclusivity, payer pressure, and generic/competition risks

Last updated: June 5, 2026

Executive summary: Nascobal is a niche endocrine/metabolic product (calcitonin) with constrained addressable demand and chronic exposure to pricing and formulary pressure. Its financial trajectory is dominated by (1) shrinking and aging patient pools for calcitonin indications, (2) limited payer tolerance for low-benefit-or-high-cost therapies, and (3) competitive erosion risk from generics and alternative therapies for osteoporosis and related indications. Near-term revenue outcomes hinge on remaining protected labeling and delivery strengths on the U.S. market and the extent to which FDA and payers steer patients toward more cost-effective options.

What is Nascobal (nasal calcitonin) and what are its main U.S. indications affecting demand?

Nascobal is a calcitonin product delivered as a nasal spray. It has historically been positioned for conditions where clinicians seek calcitonin’s antiresorptive effects, most notably:

• Osteoporosis (postmenopausal use has been central to historical demand patterns)
• Paget’s disease of bone (use has been narrower and more sensitive to safety communications and guideline shifts)
• Other calcitonin-labeled uses have varied over time and across regulatory updates

How do indication and guideline shifts translate into sales dynamics?

Calcitonin demand has been structurally pressured by:

• Uptake of bisphosphonates and denosumab and, for some patients, anabolic agents that often carry stronger efficacy or guideline support for osteoporosis.
• Ongoing prescriber migration to lower-cost or higher-benefit regimens where outcomes are better aligned with modern treatment targets.
• Increased clinical and payer scrutiny of therapies with narrower positioning, especially where alternative injectable or oral agents have broader guideline coverage.

Market effect: A product like Nascobal tends to face a “volume ceiling” even without direct generic entry because prescriber choice concentrates on guideline-preferred options.

How has the U.S. market structure for nasal calcitonin shaped Nascobal’s pricing and payer outcomes?

Nascobal competes indirectly across osteoporosis and bone health classes, and directly against any calcitonin substitutes that can be dispensed under payer formularies.

Payer pressure mechanics

Payer dynamics that typically drive calcitonin nasal products:

• Formulary tiering: Higher tiers and utilization management for non-preferred agents.
• Prior authorization: Requests tied to diagnosis confirmation, prior therapy failure, and documentation of intolerance to preferred agents.
• Step therapy: Often pushes patients to bisphosphonates first.

Pricing and net sales

Net sales trajectory for mature specialty niches like calcitonin nasal products typically compress due to:

• Higher discounting to secure formulary placement.
• Increased rebates/chargebacks as payers demand value evidence.
• Lower list price elasticity: when volume is limited, price concessions become the lever for staying within payer budgets.

Market effect: Even without aggressive competitive undercutting, payer economics can drive net revenue decline.

When does Nascobal face exclusivity and patent risk that changes the competitive landscape?

To assess exclusivity and patent-driven competitive timing for Nascobal, two sources are required for precision: FDA’s Orange Book listings for listed drug products and relevant patent expiration/expiry and exclusivity codes tied to Nascobal.

No Orange Book listing data is provided in the input context. Without the listed active ingredient, dosage form-specific product identifiers, and the Orange Book patent list, it is not possible to state specific expiration dates, exclusivity periods, or Paragraph IV timing for Nascobal.

What is the Orange Book status of Nascobal and which patents protect it?

A complete Orange Book status requires:

• The specific listed drug name and dosage form (e.g., nasal spray strength)
• The Orange Book application number
• The listed patents with expiration dates and exclusivity end dates

No Orange Book records are included in the input context. A patent- and exclusivity-specific answer would risk being incomplete or incorrect.

What generic entry risks exist for Nascobal and how could they affect market share?

Generic entry risk for mature, niche products generally follows two paths:

1. Generic calcitonin nasal spray applicants that can launch once listed patents and exclusivity expire or via Paragraph IV challenges.
2. Formulary-driven displacement by other osteoporosis agents that are preferred based on payer criteria.

Launch impact for niche nasal calcitonin

When a generic launches into a small category:

• Competitive pricing pressure can be visible even if total category volume is stable.
• Market share typically shifts quickly within treated subgroups that can use the generic, but absolute volumes may remain limited by guideline/payer preference already reducing the user base.

Market effect: The largest share risk is usually not only generics. It is the combination of payer steering plus limited remaining differentiation.

How does Nascobal compare with alternative osteoporosis and bone therapies on cost and utilization?

In practice, Nascobal’s competitive set is broader than “calcitonin products.” It includes:

• Bisphosphonates (oral and IV)
• Denosumab
• Osteoanabolic therapies in some regimens
• Other osteoporosis supportive therapies depending on the patient profile

What drives utilization away from calcitonin nasal products?

• Higher perceived efficacy and broader guideline support for modern agents.
• Better outcome alignment with measurable fracture-risk reduction endpoints.
• More predictable payer reimbursement under broad formulary coverage.

Net effect: Even if Nascobal is still reimbursed, it can lose incremental demand to favored classes.

What FDA regulatory events and safety communications have influenced calcitonin use and Nascobal demand?

Calcitonin use has been shaped by evolving safety and benefit-risk discussions over time across the class. Those communications often affect:

• Prescriber willingness to initiate therapy.
• Payer authorization criteria.
• Reimbursement stability and physician documentation requirements.

Market effect: Safety-driven caution usually hits new starts first, which matters for a mature product where growth is scarce.

How has Nascobal’s financial trajectory evolved: sales trend, profitability, and cost structure drivers?

No financial statement or sales data is included in the input context (no reported annual net sales, quarterly revenue, segment disclosures, or estimated third-party market figures). Without those, a quantified financial trajectory cannot be produced.

That said, the typical financial trajectory drivers for mature niche prescription brands like Nascobal are:

• Volume erosion from guideline and payer preference shifts.
• Net price erosion from rebates and formulary concessions.
• Higher SG&A and lifecycle spend relative to revenue base when volume declines.
• Marketing inefficiency as conversion rates drop and targeting narrows to residual patient populations.

What business dynamics matter most for the brand owner: manufacturing constraints, contracting, and distribution?

For nasal products, operational dynamics often influence service levels and can affect payer contracting outcomes:

• Batch supply stability and distribution lead times.
• Specialty pharmacy contracting and reimbursement performance.
• Wholesale account terms and rebate structures tied to purchasing patterns.

When demand is small, service-level issues can create outsized market share swings because patients have fewer alternative local supply channels.

Who markets Nascobal and how does brand ownership affect lifecycle strategy?

Brand ownership determines:

• The willingness to defend patents vs. shift to exclusivity extension strategies.
• Commercial spend intensity and payer contracting posture.
• The speed of product repositioning, reformulation, or field-of-use narrowing.

No ownership or label-holder details are included in the input context, so a precise owner-specific lifecycle assessment cannot be produced.

What patent litigation or settlements affect Nascobal competition timelines?

A litigation-focused answer requires docket data tied to:

• Orange Book patents and listed drug products
• FDA approval application(s) and any Paragraph IV notice letters
• Federal court filings and settlement terms

No litigation identifiers or case data are provided in the input context. A litigation-and-settlement timeline for Nascobal cannot be stated accurately.

Key Takeaways

• Nascobal’s market dynamics are dominated by category-level displacement by modern osteoporosis therapies and payer-driven utilization management.
• Generic and patent-exclusivity outcomes can accelerate share loss, but a precise timeline requires Orange Book listing and patent expiration data that is not present in the input context.
• Without disclosed sales data in the input context, a quantified financial trajectory is not producible; the directionality is consistent with mature niche brands facing volume and net price pressure.

FAQs

1. What drives formulary placement for calcitonin nasal spray products like Nascobal?
2. How do biosimilar and biologic osteoporosis therapies indirectly affect calcitonin nasal demand?
3. What patient subgroups are most likely to remain on nasal calcitonin when payers require step therapy?
4. How do generic entry scenarios typically change net pricing for niche endocrine brands in the U.S.?
5. What regulatory or safety label changes most commonly reduce new starts for calcitonin class therapies?

References

1. No source materials were provided in the input context to cite.

DrugChatter Q&A for NASCOBAL

Is nascobal used for pernicious anemia?
Does nascobal nasal spray cause nasal irritation?
Is nascobal for b12 deficiency?
Is nascobal a nasal spray?