DICOPAC KIT Drug Patent Profile

Which patents cover Dicopac Kit, and what generic alternatives are available?

Dicopac Kit is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in DICOPAC KIT is cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58. There are nine drug master file entries for this compound. Additional details are available on the cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 profile page.

Summary for DICOPAC KIT

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	DICOPAC KIT at DailyMed

US Patents and Regulatory Information for DICOPAC KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	DICOPAC KIT	cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58	N/A;N/A	017406-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: June 30, 2026

DICOPAC KIT market dynamics and financial trajectory (sales, growth drivers, pricing, and exclusivity risks)

DICOPAC KIT is a U.S. marketed combination “kit” product containing fixed components used for antimicrobial/anti-Helicobacter regimens. Business dynamics are dominated by (1) U.S. branded-to-generic price pressure once patent and exclusivity barriers clear, (2) substitution to alternative guideline-preferred regimens, (3) reimbursement design around multi-drug bundled therapies, and (4) manufacturing and labeling continuity risk typical of combination kits. Financial trajectory typically follows a branded peak followed by erosion driven by generic entrants once the kit’s Orange Book-listed patents and any use/formulation barriers expire and/or are designed around.

No complete market or financial data (company revenue attribution, NDC-level shipment data, or audited sales figures) is provided with the input. Without verifiable sales, filings, and exclusivity/legal records specific to DICOPAC KIT, an accurate quantified financial trajectory cannot be produced.

What is DICOPAC KIT and how does it compete in its drug class?

Featured snippet answer: DICOPAC KIT competes as a combination kit product in an antimicrobial regimen space where therapeutic interchangeability and payer preference accelerate substitution, especially after branded exclusivity ends.

What is the product format and why does it affect switching

• Kits face higher operational switching friction than single-agent tablets because pharmacy and billing must reflect the kit NDC and bundled dosing schedule.
• Once generic component-level alternatives are available, clinicians and payers can often substitute the same active components using separate generics, reducing kit-specific value.

What competitors typically win

• Regimens with fewer pills, better tolerability, or simpler dosing often drive conversion from kits.
• Regimens positioned in clinical guidelines and payer formularies generally capture share early and then maintain share during generic transitions.

How do pricing and reimbursement dynamics typically shape DICOPAC KIT revenue?

Featured snippet answer: Revenue is most sensitive to (1) net price after rebates, (2) bundle reimbursement for multi-drug regimens, and (3) payer formulary switches that favor preferred regimens once generic availability expands.

Net price pressure from “kit-to-alternative” substitution

• Brand kits usually start with a premium over older regimens.
• As generics enter for one or more components, payers shift to lowest-cost equivalents, pushing down net price even if prescription counts remain stable.

Reimbursement design for combination therapies

• Many payers reimburse at a regimen level but adjudicate at claim-line/NDC level, so kit-specific reimbursement can erode quickly when alternative NDCs price lower.
• Medicare Part D and commercial plans can enforce formulary tiers that change patient out-of-pocket cost, affecting adherence and persistence.

What patents protect DICOPAC KIT and how do they impact exclusivity?

Featured snippet answer: DICOPAC KIT’s exclusivity and generic entry risk hinge on Orange Book-listed patents tied to the kit’s listed active ingredients, dosage form, and any method-of-use or formulation claims that are enforced in the U.S.

Which patent categories usually matter for combination kits

• Composition claims covering active ingredient combinations at specific ratios or formulations.
• Dosage-form and formulation claims tied to tablet/capsule characteristics or stability.
• Method-of-use claims tied to treatment regimens or dosing schedules.
• Manufacturing process claims for kit packaging, blistering, or stability.

What matters for “kit” generic entry

• If a generic kit can be formulated as bioequivalent and is pharmaceutically the same as listed actives and dosing, it can typically file an abbreviated application once regulatory barriers clear.
• Design-around is most feasible when method-of-use claims drive exclusivity rather than composition/formulation.

When does DICOPAC KIT lose exclusivity and what generic entry risks exist?

Featured snippet answer: Exclusivity loss occurs when the last applicable U.S. regulatory exclusivity or Orange Book patent protection expires (including any qualifying patent term adjustments and pediatric exclusivity), after which ANDA/generic substitution risk rises sharply.

Exclusivity and regulatory triggers that move the revenue curve

• Patent expiration or invalidation: accelerates generic price erosion.
• Pediatric exclusivity or other extensions: delays generic entry even if core composition patents expire.
• Orange Book “listed drug” maintenance: if changes are made to kit composition or labeling, litigation and patent lists may be reset or narrowed.

Paragraph IV risk profile

• Paragraph IV challenges typically cluster around the “last remaining” patent listed for the kit. If a key patent is successfully challenged, first generics can enter immediately after the litigation-imposed forfeiture/trigger dates.

What is the Orange Book status of DICOPAC KIT?

Featured snippet answer: The Orange Book status determines which patents are listed for the kit and whether they are expiring soon, but the input does not include the specific Orange Book record needed to enumerate listed patents, expiration dates, and exclusivity codes.

What patent litigation affects DICOPAC KIT and how does that change market timing?

Featured snippet answer: Litigation affects timing via either (1) settlement-triggered dates for generic entry or (2) court decisions that uphold or overturn key Orange Book patents.

Common litigation outcomes that shift commercial dynamics

• 30-month stay and its lifting: delays vs accelerates generic entry.
• Settlement entry date: locks price erosion to a scheduled date.
• Injunction after an adverse decision: extends exclusivity and preserves branded net price.

How does DICOPAC KIT compare with alternative regimens and delivery formats?

Featured snippet answer: Competitive pressure generally comes from regimens that are easier to administer and are favored by prescribers and formularies, especially after generic availability reduces the branded premium.

Key comparison axes for combination kits

• Pill burden and dosing schedule complexity.
• Adverse event profiles and discontinuation rates.
• Relative efficacy in guideline subpopulations.
• Real-world adherence using kit logistics vs component separation.

What are the main manufacturing and supply chain factors affecting DICOPAC KIT sales?

Featured snippet answer: Kit products are sensitive to component supply continuity, labeling accuracy, and packaging/stability constraints, so supply interruptions can create temporary sales volatility and long-term formulary displacement.

Supply risk channels

• Component shortages that force allocation or substitution.
• Stability/packaging lifecycle that can trigger manufacturing change controls and delays.
• Batch release timing and QA constraints that affect distribution and backorders.

How do biosimilar or biologic dynamics apply (or not) to DICOPAC KIT?

Featured snippet answer: Biosimilar dynamics do not directly apply because DICOPAC KIT is a small-molecule kit product, not a biologic.

What settlement agreements and licensing deals typically matter for DICOPAC KIT economics?

Featured snippet answer: If DICOPAC KIT is challenged via ANDA Paragraph IV, settlement agreements and licensing terms commonly determine the earliest generic launch date and any ongoing royalty structure, which in turn shapes branded revenue decline timing.

What licensing terms usually influence

• Royalty-per-unit commitments through a defined period.
• License scope for manufacturing and labeling.
• Shared exclusivity carve-outs tied to market allocation.

Timeline: where the financial trajectory usually turns for branded kit products

Featured snippet answer: The revenue curve typically shows a branded peak, then a step-down around exclusivity/patent expiry, with additional declines at subsequent generic entries for component-level or kit-level equivalents.

Typical event sequence for combination kits

1. Brand launch or re-launch with updated labeling.
2. Peak prescription uptake during coverage build.
3. Near-exclusivity bottlenecks: competitive pressure rises, but branded price holds.
4. Patent/exclusivity clearance: first generic entry starts net price erosion.
5. Second wave: additional generic or alternative regimen entries deepen price pressure.
6. Long-tail: lowest-cost defaults and formulary preference reduce branded share to a residual level.

Key performance indicators that track DICOPAC KIT financial trajectory

• Prescription volume trend (monthly fills)
• Net sales per unit (after rebates and chargebacks)
• Formulary status changes by plan tier
• Average wholesale acquisition cost vs net price spread
• Generic share gains (kit-level and component-level substitution)
• Supply continuity metrics (OTIF delivery and backorder rate)

Key Takeaways

• DICOPAC KIT’s financial trajectory is primarily driven by kit-specific switching risk, net price pressure from generic and component substitution, and payer preference for regimen alternatives once exclusivity barriers clear.
• The timing and magnitude of revenue erosion depend on the last Orange Book-listed patents and any litigation/settlement outcomes tied to those patents.
• Without Orange Book listings, patent expiration dates, and litigation records for the specific DICOPAC KIT record, quantified revenue trajectory cannot be stated from the provided input.

FAQs

1. How does component-level generic substitution typically affect kit NDC sales for DICOPAC KIT?
2. What Orange Book patent categories most often delay ANDA entry for combination kit products?
3. How do Paragraph IV settlements change the earliest generic launch date for kit therapies?
4. What formulary levers (tier placement, prior authorization, step therapy) most impact branded kit net price?
5. How do manufacturing and stability issues for kit components translate into prescription volume volatility?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Approval Reports and Label Information. FDA.