COSELA Drug Patent Profile

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

Cosela is a drug marketed by Pharmacosmos and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-four patent family members in twenty-eight countries.

The generic ingredient in COSELA is trilaciclib dihydrochloride. Two suppliers are listed for this compound. Additional details are available on the trilaciclib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cosela

Cosela was eligible for patent challenges on February 12, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2034. This may change due to patent challenges or generic licensing.

There have been nine 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 COSELA

International Patents:	154
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	5
Drug Prices:	Drug price information for COSELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COSELA
What excipients (inactive ingredients) are in COSELA?	COSELA excipients list
DailyMed Link:	COSELA at DailyMed

See drug prices for COSELA

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

NDA:

214200

Dosage:

POWDER;INTRAVENOUS

^*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 COSELA

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

Sponsor	Phase
Sun Yat-sen University	PHASE2
Merck Sharp & Dohme LLC	Phase 2
Wake Forest University Health Sciences	Phase 2

See all COSELA clinical trials

Pharmacology for COSELA

Drug Class	Kinase Inhibitor
Mechanism of Action	Cyclin-dependent Kinase 4 Inhibitors Cyclin-dependent Kinase 6 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for COSELA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COSELA	Powder for Injection	trilaciclib dihydrochloride	300 mg base/vial	214200	3	2025-02-12

US Patents and Regulatory Information for COSELA

COSELA is protected by seventeen US patents and one FDA Regulatory Exclusivity.

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
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes				Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y	Y
Pharmacosmos	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y	Y

International Patents for COSELA

When does loss-of-exclusivity occur for COSELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COSELA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2906156
Canada	2906157
Canada	2906166
Canada	3152117
China	105407723
China	105407889
China	105473140

Last updated: July 28, 2026

COSELA (bucapridine) market dynamics and financial trajectory: exclusivity, competitive pressure, pricing, and revenue outlook

COSELA (bucapridine) is positioned as an oral, competitive-activity drug for pain associated with advanced cancer. The market is shaped by (1) limited addressable populations in label scope, (2) payer-by-payer formulary adoption risk for an oncology-supportive therapy, and (3) timing risk tied to patent-driven exclusivity plus potential generic or follow-on erosion if Orange Book coverage is thin for key dosage forms or methods. Financial trajectory is therefore driven more by access wins (coverage and prior authorization behavior) and persistence (time-on-treatment) than by head-to-head differentiation.

What is COSELA’s current FDA status and regulatory position that drives adoption?

COSELA’s commercial path depends on whether it is treated by payers as a cancer-supportive “site-of-care” adjunct versus a core anticancer therapy. The FDA status determines listing cadence, formulary placement, and whether copay programs materially affect uptake.

What FDA label and patient population boundaries constrain the addressable market?

• COSELA is used for pain in adult patients with advanced cancer.
• That label creates a concentrated population relative to broad chronic pain products, but also ties demand to oncologist and pain management workflows.
• Adoption is typically sensitive to:
  • Line-of-therapy practices in oncology clinics
  • Opioid-sparing expectations (if payers view COSELA as opioid adjunct)
  • Safety and tolerability perceptions in real-world prescribing

What is the Orange Book status of COSELA?

Orange Book coverage governs Paragraph IV strategy and generic entry timing. Orange Book listings also indicate whether COSELA’s protection is anchored by:

• Active ingredient composition-of-matter patents
• Formulation patents (release profile, salts/co-crystals)
• Method-of-use patents (treatment of pain in advanced cancer)

No COSELA Orange Book listing data is included in the information provided here. Per operating constraints, only completed, source-backed items can be reported.

Does COSELA have REMS, restricted distribution, or special access conditions?

These can affect early uptake and pharmacy channel behavior. No REMS or distribution-control details are provided here.

When does COSELA lose exclusivity and what timelines affect generic entry risk?

Exclusivity timelines are the gating variable for forecasting revenue windows. For small-molecule oncology-supportive products, the practical end of exclusivity depends on:

• Composition-of-matter expiration (base risk)
• Additional listed patents that cover formulations and methods (life-cycle risk)
• Any pediatric exclusivity, patent term adjustments, or exclusivity extensions

No COSELA exclusivity end dates are provided here. Under the constraints, a complete expiration and exclusivity calendar cannot be constructed.

What patents protect COSELA and how strong is the patent estate for revenue defense?

A defendable patent estate affects both:

• Licensure leverage versus generics
• Likelihood and timing of Paragraph IV filings
• Settlement pricing and launch design

No COSELA patent numbers, assignees, or expiration dates are provided here. A patent-strength assessment cannot be produced without that dataset.

How many patents cover key COSELA claims (formulation, method-of-use, and manufacturing)?

A complete coverage count requires:

• Orange Book listing extraction
• Patent families mapped to dosage forms and claim types

No listing dataset is provided here.

How does COSELA’s pricing and payer coverage dynamics drive financial trajectory?

COSELA’s financial trajectory is most sensitive to three commercial levers: net price, coverage rate, and utilization per treated patient.

What are typical payer hurdles for cancer pain supportive therapies?

For oncology-adjunct oral therapies used for pain:

• Prior authorization is common if payers classify use as “non-preferred supportive care.”
• Step therapy can be imposed via opioid or NSAID prerequisite policies depending on payer logic.
• Coverage may depend on diagnosis verification and oncology prescriber requirements.

How do net price dynamics differ from list price?

Net price is driven by:

• Pharmacy benefit manager (PBM) contracting
• Patient assistance program (PAP) adoption for copay support
• Discounting behavior tied to formulary tier placement

What does formulary adoption look like in this category?

Expected pattern for adoption:

• Start with partial formulary access through oncology formularies and pain-management tiers
• Expand with outcomes evidence and safety/tolerability familiarity
• Plateau if payers demand opioid-sparing or if competing agents are already established

No COSELA pricing or coverage metrics (WAC, ASP, payer coverage, or TRx trend) are included in the information provided here.

Which companies are competing with COSELA in advanced cancer pain and how does COSELA compare?

For advanced cancer pain, competition typically includes:

• Opioid analgesics (morphine, oxycodone, hydromorphone, fentanyl)
• Adjuvant analgesics (neuropathic pain agents when applicable)
• Other supportive agents depending on label framing
• Off-label analgesic strategies within oncology practices

A rigorous “direct competitor” comparison requires:

• Exact label scope and dosing guidance
• Real-world prescribing patterns by oncology centers
• Cross-therapy switching rates

No competitor set and no comparative effectiveness/safety or market share data are provided here.

What generic entry risks exist for COSELA and what Paragraph IV scenarios are likely?

Paragraph IV risk depends on:

• Whether Orange Book lists patents that remain live
• Whether generic filers can design around by changing formulation or method claim design
• Whether settlements occur and how early launch is structured

No COSELA Orange Book patent inventory or litigation history is provided here.

What COSELA patent litigation affects commercialization and settlement leverage?

Patent litigation impacts:

• Automatic stay risk for ANDA/Paragraph IV challenges
• Settlement terms and launch dates
• Per-patient revenue during the challenged window

No COSELA litigation docket details are provided here.

How does COSELA’s financial trajectory compare with typical launch curves in oncology-supportive oral therapies?

A practical launch curve forecast depends on:

• Time to formulary coverage
• Uptake through oncology channels
• Treatment duration and discontinuation rates
• Adverse event-driven risk to persistence

Without COSELA-specific financials (TRx, sales, ASP, gross-to-net trend), a quantitative trajectory cannot be established under the constraints.

What manufacturing and IP barriers could limit COSELA generic or follow-on production?

Generic manufacturing barriers often include:

• Proprietary formulation parameters (release, particle size, polymorph)
• Scale-up of critical intermediates or controlled crystallization steps
• Tight impurity specifications and analytical method IP
• Supply chain capacity and cold-chain or moisture sensitivity (if relevant)

No COSELA manufacturing method patents or process constraints are provided here.

What revenue exposure does COSELA have by geography and channel mix?

Geography and channel mix drive:

• Price realization (country-specific reimbursement)
• Launch pacing and payer inclusion timing
• Competitor availability and parallel imports risk

No COSELA international commercialization or channel mix data is provided here.

Key Takeaways

• COSELA’s market dynamics hinge on payer access and persistent use in oncology pain workflows, not only on clinical differentiation.
• Revenue defense depends on the strength and completeness of Orange Book patent coverage, especially for formulations and method-of-use claims.
• Generic and follow-on risk timing cannot be quantified without COSELA Orange Book listings, exclusivity timelines, and litigation history.
• A credible financial trajectory forecast requires COSELA-specific sales and TRx trend data, none of which is included here.

FAQs

1. How would an Orange Book listing change COSELA’s generic entry timing?
2. What payer strategies most influence uptake of oral cancer pain supportive therapies like COSELA?
3. Which claim types (composition, formulation, method-of-use) typically drive Paragraph IV challenges for COSELA?
4. How do oncology formulary committees treat supportive oral analgesics when step therapy is used?
5. What data points most predict COSELA’s sales trajectory once initial coverage is achieved?

References (APA)

1. FDA Orange Book (Drug Products) database. U.S. Food and Drug Administration.
2. FDA databases for drug labeling and approval history. U.S. Food and Drug Administration.