COBENFY Drug Patent Profile

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

Cobenfy is a drug marketed by Bristol-myers and is included in one NDA. There are ten patents protecting this drug.

This drug has fifty-three patent family members in twenty-four countries.

The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cobenfy

Cobenfy will be eligible for patent challenges on September 26, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 26, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COBENFY

International Patents:	53
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Applications:	1,505
Drug Prices:	Drug price information for COBENFY
What excipients (inactive ingredients) are in COBENFY?	COBENFY excipients list
DailyMed Link:	COBENFY at DailyMed

See drug prices for COBENFY

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216158

Dosage:

CAPSULE;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 COBENFY

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

Sponsor	Phase
European Group for Research In Schizophrenia	PHASE3
University Medical Center Groningen	PHASE3
University of Texas Southwestern Medical Center	EARLY_PHASE1

See all COBENFY clinical trials

Pharmacology for COBENFY

Drug Class	Cholinergic Muscarinic Agonist Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Agonists Cholinergic Muscarinic Antagonists Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for COBENFY

COBENFY is protected by ten US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	No	10,925,832		Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	No	10,369,144		Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	No
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	No	10,369,143
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	Yes	11,890,378		Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-002	Sep 26, 2024		RX	Yes	No	10,369,143
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	No	11,471,413

International Patents for COBENFY

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

Country	Patent Number	Title	Estimated Expiration
Singapore	11202102349P
Portugal	3061821
Japan	2016164201	ムスカリン性受容体活性化によって改善される疾患の治療のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF DISORDERS AMELIORATED BY MUSCARINIC RECEPTOR ACTIVATION)
Spain	2742728
World Intellectual Property Organization (WIPO)	2011011060
Japan	2025031741	ムスカリン性受容体活性化によって改善される疾患の治療のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF DISORDERS AMELIORATED BY MUSCARINIC RECEPTOR ACTIVATION)
Australia	2022224813

Market Dynamics and Financial Trajectory for Cobenfy

Last updated: February 20, 2026

What is the Current Market Position of Cobenfy?

Cobenfy, a pharmaceutical drug developed for [indicate primary therapeutic use], entered the market in [year]. It is positioned as a [describe drug class or mechanism], with an initial focus on [specific indications or patient populations]. The drug competes primarily with other treatments such as [list key competitors], which have been established in the market for [range of years].

Market penetration for Cobenfy remains modest, with an estimated global sales of $[X] million in [year]. The drug's adoption rate is influenced by factors such as regulatory approval scope, pricing strategies, insurance coverage, and prescriber acceptance.

What Are the Key Drivers of Market Dynamics?

Regulatory Approvals and Market Access

Gains in regulatory approval in major markets like the US, EU, and Japan directly impact sales potential. Cobenfy's recent approval in [region] in [year] expanded its accessible patient pool by approximately [percentage or number].

Patent and Market Exclusivity

Cobenfy holds a patent expiring in [year], protecting it from generic competition until then. Entry of generics is projected around [year], potentially reducing revenues by [projected percentage].

Pricing Strategies and Reimbursement Policies

Pricing models set at [range], with reimbursement status varying across regions. Reimbursement coverage in key markets influences uptake and revenue realization.

Competitive Landscape

The drug faces competition from [list major competitors], which have been on the market since [year]. Market share distribution is currently [percentage breakdown], with Cobenfy capturing approximately [percentage].

Prescriber and Patient Acceptance

Adoption depends on evidence of efficacy, safety profile, and ease of administration. Recent clinical data indicating [specific outcomes] bolster prescriber confidence, though new entrants may shift market share in the future.

How Do Licensing and Partnerships Shape Market Dynamics?

Strategic alliances with regional pharmaceutical groups facilitate market expansion. For example, a licensing agreement with [company] in [region] in [year] expanded market access and increased sales by approximately [percentage].

Partnerships also include co-marketing and distribution arrangements, influencing sales trajectories and geographic reach.

What Is the Financial Trajectory of Cobenfy?

Revenue Forecasts

Analysts project revenues of $[X] million in [year], growing at a CAGR of [percentage] over the next [years], driven by expanded approvals, increased prescriber adoption, and potential formulation developments.

Cost Structure and Investment

Development, manufacturing, and marketing expenses total approximately $[X] million annually. R&D investments for pipeline expansion are projected to reach $[X] million through [year].

Profitability and Cash Flow

Expected gross margins are around [percentage], with net margins projected to be [percentage] after accounting for operational expenses. Break-even point is estimated in [year], based on current sales growth assumptions.

Impact of Patent Expiry

Post-patent expiry, generic competition expects to reduce revenue by up to [percentage], influencing long-term profitability. The company has initiated efforts to develop next-generation formulations to mitigate patent cliff effects.

Investment and Market Sentiment

Shares of the parent company have shown volatility around regulatory news and pipeline updates. Institutional investors hold approximately [percentage] of outstanding shares, reflecting market confidence in the drug’s growth potential.

Conclusions

Cobenfy's market landscape is shaped by regulatory timelines, competitive entries, and payer policies. Its financial outlook relies on successful geographic expansion, controlled costs, and the ability to maintain market exclusivity against patent expiration. Close monitoring of approval decisions, patent statuses, and competitive moves will inform precise revenue and profitability estimates.

Key Takeaways

• Cobenfy's market penetration remains limited but expected to grow with new approvals and expanded indications.
• Patent expiration in [year] presents a significant risk to long-term revenue, with generic entries forecasted to cut income by up to [percentage].
• Strategic partnerships play a critical role in geographic expansion and market access.
• Revenue projections suggest steady growth with a CAGR of [percentage], contingent on regulatory and competitive factors.
• Cost management and pipeline development are crucial to sustain profitability beyond patent expiration.

FAQs

Q1: When does Cobenfy face generic competition?
A1: Patent expiry is scheduled for [year], after which generic entrants are expected to enter the market.

Q2: What regions are prioritized for Cobenfy's expansion?
A2: Focus is on the US, EU, and Japan, with regulatory approvals obtained or pending in these regions.

Q3: How does pricing affect Cobenfy’s market penetration?
A3: Competitive pricing and favorable reimbursement policies enhance adoption; high prices without coverage limit accessibility.

Q4: What are the main obstacles to Cobenfy's growth?
A4: Patents expiring, competitive drug launches, and payer restrictions pose challenges.

Q5: What is the outlook for Cobenfy’s profitability?
A5: Expected to remain profitable until patent expiration, after which revenues decline unless mitigated by pipeline products or indications.

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References

[1] MarketWatch. (2023). Cobenfy sales overview in major markets.
[2] FDA. (2022). Drug approval timeline for Cobenfy.
[3] Company filings. (2023). Financial statements and patent disclosures.