NUMBRINO Drug Patent Profile

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

Numbrino is a drug marketed by Omnivium Pharms and is included in one NDA. There are eleven patents protecting this drug.

The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Numbrino

Numbrino was eligible for patent challenges on December 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2037. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NUMBRINO

US Patents:	11
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUMBRINO

US Patents and Regulatory Information for NUMBRINO

NUMBRINO is protected by eighteen 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
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes			Y
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes

Last updated: April 23, 2026

NUMBRINO: Investment Scenario and Fundamentals Analysis

What is “NUMBRINO” and what assets does it map to?

No investable drug asset can be mapped from the identifier “NUMBRINO” with sufficient specificity to support a correct patent- and fundamentals-based investment scenario.

Because “NUMBRINO” is not an unambiguous drug or INN identifier in the available knowledge base, any attempt to assign:

• a therapeutic indication,
• an active pharmaceutical ingredient (API),
• a development stage or regulatory status,
• or an enforceable patent estate,

would risk producing an incorrect investment profile and incorrect legal-risk conclusions.

What is the market and clinical position of NUMBRINO?

A fundamentals framework (epidemiology, incidence, guideline position, payer dynamics, competitor set, and clinical differentiation) requires an unambiguous mapping from “NUMBRINO” to a specific drug substance and regimen. That mapping is not possible from the provided identifier.

Without the underlying drug identity, the following cannot be calculated or validated:

• addressable patient population by indication,
• expected uptake drivers (label scope, line-of-therapy fit),
• trial evidence quality and endpoints,
• safety liabilities that affect market access,
• forecasted pricing power versus therapeutic alternatives.

How strong is the patent and exclusivity position behind NUMBRINO?

A patent strength assessment requires:

• the exact API and composition(s),
• the relevant jurisdiction set,
• publication and grant status of core claims,
• and term and extension mechanics (e.g., patent term adjustment, SPCs, pediatric extensions), all tied to specific patent documents.

No enforceable patent corpus can be generated for “NUMBRINO” without an authoritative link to a specific drug substance and filing family.

Is NUMBRINO generic risk-exposed?

Generic and biosimilar risk depends on:

• whether the drug has a reference product and how it is classified,
• the maturity of the patent estate,
• and whether paragraph IV style or generic design-around pathways exist.

Those determinations cannot be made without drug identity and the corresponding legal record.

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Investment Scenario Framework (What would be evaluated if the drug were unambiguously identified)

Commercial valuation drivers

A standard investment-grade commercialization model would use:

• Indication and label scope: FDA/EMA authorization boundaries and wording
• Line of therapy: first-line vs later-line affects conversion and duration
• Evidence: phase, endpoints (PFS/OS/Sustained response), subgroup signal
• Safety: discontinuation rates, class warnings, monitoring burden
• Pricing and reimbursement: WAC-to-net assumptions, payer criteria, formulary trajectory

No such model can be anchored to NUMBRINO as provided.

Risk-adjusted R&D and de-risking milestones

A risk-adjusted scenario would track:

• ongoing studies (phase 2/3, head-to-head, real-world evidence)
• enrollment and topline timing
• label expansion probabilities (new endpoints or populations)
• CMC scale-up and supply qualification

Again, this requires the drug’s actual development program.

Patent-based cash-flow survival

An investment case typically projects:

• earliest patent expiration by claim type (composition, method, formulation, use)
• exclusivity layers (regulatory exclusivities and paediatric extensions where applicable)
• geographic coverage and enforcement posture
• potential launch-at-risk windows after last meaningful legal barrier

No patent timeline can be constructed for NUMBRINO without identifying the asset.

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Actionable Outcome

No investment scenario or fundamentals analysis can be produced for “NUMBRINO” without mapping it to a specific, legally and clinically identifiable drug asset. Generating one would introduce unacceptable error risk into patent life, competitive positioning, and market forecasts.

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Key Takeaways

• “NUMBRINO” does not map to a single, verifiable drug asset sufficient to build an investment-grade fundamentals or patent analysis.
• Market sizing, clinical positioning, payer dynamics, and competitor set cannot be determined without the underlying API and indication.
• Patent strength, exclusivity duration, and generic-risk cannot be assessed without a specific patent family and jurisdiction set tied to the correct drug substance.

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FAQs

1. What does NUMBRINO refer to in the pharmaceutical market?
   It cannot be matched to a single drug asset from the provided identifier.

2. Can you estimate NUMBRINO’s TAM and revenue potential?
   Not without an unambiguous indication, API, and regulatory status.

3. What is NUMBRINO’s patent life and exclusivity strategy?
   Patent life cannot be calculated without the associated drug identity and patent documents.

4. Is NUMBRINO at risk from generics or design-arounds?
   Generic risk cannot be evaluated without the specific legal record and patent claims.

5. How would you build the investment case once the drug is identified?
   By combining label scope, clinical evidence, pricing/reimbursement dynamics, and a jurisdiction-by-jurisdiction patent and exclusivity waterfall.

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References

[1] No sources cited (insufficient unambiguous identification of the drug “NUMBRINO”).