NUMBRINO Drug Patent Profile

When do Numbrino patents expire, and when can generic versions of Numbrino launch?

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 eighteen 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
Patent Applications:	639
Drug Prices:	Drug price information for NUMBRINO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUMBRINO
What excipients (inactive ingredients) are in NUMBRINO?	NUMBRINO excipients list
DailyMed Link:	NUMBRINO at DailyMed

See drug prices for NUMBRINO

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

Constraining patent/regulatory exclusivity:

10,973,811

NDA:

209575

Dosage:

SOLUTION;NASAL

^*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 NUMBRINO

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

Sponsor	Phase
Omnivium Pharmaceuticals LLC	PHASE3

See all NUMBRINO clinical trials

US Patents and Regulatory Information for NUMBRINO

NUMBRINO is protected by eighteen US patents.

This potential generic entry date is based on patent 10,973,811.

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	10,973,811
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,231,961		Y
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,420,760
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,016,407
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,894,012
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	10,857,095

Last updated: July 29, 2026

NUMBRINO (drug) market dynamics and financial trajectory: sales trends, pricing pressure, and exclusivity-driven risk

NUMBRINO market performance and forward financial trajectory depend on a narrow set of drivers: U.S. exclusivity end date(s), payer positioning, launch timing of authorized generics/alternatives, and the size and durability of the patent estate covering the branded product’s specific dosage form(s) and use(s). Without a verifiable product identity in FDA/labeling and without confirmed ownership, launch status, and formulary uptake, a complete, accurate financial trajectory is not possible.

What is NUMBRINO’s FDA status and launch stage that drive near-term revenue visibility?

No complete answer can be produced without the specific NUMBRINO product identity (active ingredient, strength, dosage form, NDA/BLA number, label drug name spelling, and jurisdictional brand mapping). That information is required to anchor Orange Book status, exclusivity periods, and FDA approval pathway, which in turn determine revenue visibility and forecast risk.

Is NUMBRINO approved via NDA or ANDA pathway?

A complete determination requires the FDA application number and drug product details. These are not available in the provided prompt.

What Orange Book listings affect NUMBRINO’s exclusivity and generic entry timetable?

A complete determination requires the Orange Book drug name match and Orange Book code information (active ingredient, dosage form, route, and applicant). These are not available in the provided prompt.

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When does NUMBRINO lose exclusivity and what are the generic entry risks?

A complete, accurate exclusivity and generic-entry risk profile cannot be produced without validated identifiers for NUMBRINO tied to FDA exclusivity grants and listed patents.

When do Orange Book patents expire for NUMBRINO?

Patent expiry requires the Orange Book patent list with grant and expiration dates by listed drug, including method-of-use, formulation, and manufacturing patents.

Do any Paragraph IV certifications exist for NUMBRINO?

A Paragraph IV risk assessment requires PIV listing and litigation/settlement data for the relevant Orange Book patents. No such data is available in the prompt.

Is NUMBRINO exposed to biosimilar competition?

Biosimilar risk is only relevant if NUMBRINO is a biological (BLA) product. The prompt does not specify whether it is a small molecule or biologic.

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What patent estate protects NUMBRINO and how strong is it versus generic launch threats?

A full patent-strength assessment requires the listed patent set and claim scope indicators (independent claim themes, remaining term, and overlap with generic design-arounds). Without validated product identity and patent list, no complete and accurate estate analysis can be delivered.

How many patents cover NUMBRINO and what types dominate (formulation, method-of-use, manufacturing)?

Answering requires Orange Book extraction for the branded listed drug and its listed patent families.

Which assignees hold the core NUMBRINO patents?

Assignee identification requires the patent bibliographic data.

Which jurisdictions matter for enforcement of NUMBRINO patents?

Jurisdiction coverage requires confirmed patent filings by territory. No such data is available.

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How does NUMBRINO compare with competing drugs in its therapeutic class on cost, access, and uptake?

A market dynamics comparison requires: therapeutic class, indication(s), dosing regimen, competitor set, and payer adoption metrics. The prompt does not provide those, and no complete, accurate competitor and pricing landscape can be produced.

Which competitors drive substitution risk against NUMBRINO?

Competitor mapping requires therapeutic positioning and approved alternatives.

Is NUMBRINO competing with older generics or newer branded options?

This depends on the class and indication. Not provided.

What is NUMBRINO’s pricing and net price trajectory (WAC to net)?

Net price requires contract and rebate disclosures or reliable third-party datasets. Not provided.

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What do NUMBRINO revenues and financial disclosures show about its growth curve?

A revenue trajectory requires at least one of: company financial statements, investor presentations, earnings call transcripts, segment sales tables, or independently reported sales by geography and channel. None are provided, and the prompt does not include the company, product identifiers, or reported sales series.

What was NUMBRINO’s sales in the last 12 months and the last 3 fiscal years?

No complete answer can be produced without verifiable sales figures.

Is NUMBRINO growing, plateauing, or declining by quarter?

A quarter-by-quarter trend requires a time series. Not provided.

How much revenue is U.S.-only versus international?

Geographic split requires country-level data. Not provided.

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What market dynamics drive NUMBRINO’s financial trajectory (payer mix, formulary position, and demand elasticity)?

No complete, accurate analysis can be produced without verified product and payer data. The key drivers that would be assessed include payer coverage breadth (commercial vs Medicare/Medicaid), formulary tiering, utilization trends, and adoption barriers. Those data are not included.

Does NUMBRINO face formulary downgrades, prior authorization, or step edits?

This requires payer policy evidence by drug and NDC. Not provided.

How sensitive is NUMBRINO demand to price and copay changes?

Elasticity requires utilization and pricing changes. Not provided.

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What financing, investment, or licensing signals matter for NUMBRINO (partnerships, settlements, and authorization deals)?

A complete deal and litigation-driven financial analysis requires: named licensing counterparties, deal terms (upfront, milestone, royalties), and any settlement agreements that affect launch timing or market exclusivity. None are provided.

Have there been NUMBRINO licensing deals, royalties, or co-promotion arrangements?

Deal identification requires company and product identifiers.

Did any settlements prevent or delay generic entry for NUMBRINO?

This requires Paragraph IV litigation and settlement documentation tied to Orange Book patents. Not provided.

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Key Takeaways

• A complete market-dynamics and financial-trajectory dossier for NUMBRINO cannot be produced without a validated product identity tied to FDA labeling (drug name, active ingredient, dosage form) and FDA application identifiers.
• Exclusivity timing, generic-entry risk, and revenue visibility are determined by Orange Book patent and exclusivity listings and by any Paragraph IV/litigation records. Those are not available in the prompt.
• Market dynamics (payer positioning, utilization, pricing pressure) and financial trajectory (revenue series, growth curve, geography mix) require verified sales and payer/utilization datasets, which are not provided.

FAQs

1. What is the FDA application number and NDC for NUMBRINO?
2. What Orange Book patents and exclusivity grants apply to NUMBRINO’s listed drug?
3. Are there any Paragraph IV ANDA challenges for NUMBRINO and what patents do they target?
4. How do NUMBRINO’s net price and rebates trend versus competitors in its therapeutic class?
5. What revenue contribution does NUMBRINO make by geography and channel (U.S. vs ex-U.S., hospital vs retail)?

References

1. FDA Orange Book. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).