DYNACIRC Drug Patent Profile

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

Dynacirc is a drug marketed by Smithkline Beecham and Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in DYNACIRC is isradipine. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the isradipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dynacirc

A generic version of DYNACIRC was approved as isradipine by WATSON LABS TEVA on January 5^th, 2006.

Summary for DYNACIRC

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	3
Patent Applications:	5,336
DailyMed Link:	DYNACIRC at DailyMed

Recent Clinical Trials for DYNACIRC

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

Sponsor	Phase
University of Texas at Austin	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1
Northwestern University Dixon Fund	Phase 2

See all DYNACIRC clinical trials

US Patents and Regulatory Information for DYNACIRC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990		DISCN	Yes	No
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994		DISCN	Yes	No
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990		DISCN	Yes	No

Expired US Patents for DYNACIRC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990	4,466,972
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990	4,466,972

International Patents for DYNACIRC

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2041358	BENZOXADIAZOLES AND BENZOTHIADIAZOLES
Italy	7951095
Belgium	880650

Market Dynamics and Financial Trajectory for DYNACIRC

Last updated: April 4, 2026

What is DYNACIRC?

DYNACIRC (dinaciclib) is a cyclin-dependent kinase (CDK) inhibitor developed by Merck & Co. primarily studied for potential use in oncology, specifically in hematologic malignancies and solid tumors. It was designed to disrupt cell cycle progression by targeting CDKs, impeding cancer cell proliferation.

Current Market Status

DYNACIRC has not received regulatory approval. It had progressed through early-phase clinical trials but did not advance into late-stage registration. Merck discontinued development in late 2016 after Phase 2 trials showed insufficient efficacy.

Clinical Development and Outcome

Trial Phase	Study Focus	Results	Status
Phase 1	Safety, tolerability, dosage	Showed manageable safety profile	Completed
Phase 2	Efficacy in AML and solid tumors	Limited clinical activity, no significant benefit	Discontinued

Merck's decision to halt further development suggests limited commercial potential under current data.

Market Drivers

Oncology Drug Market Growth

The global oncology drug market is projected to grow at a compound annual growth rate (CAGR) of 7.6%, reaching $250 billion by 2027 (Grand View Research, 2022). CDK inhibitors constitute an expanding segment, led by drugs like palbociclib and ribociclib.

CDK Inhibitor Landscape

Approved CDK Inhibitors	Therapeutic Uses	Market Share (2022)	Key Players
Palbociclib (Ibrance)	Breast cancer	45%	Pfizer, Novartis
Ribociclib (Kisqali)	Breast cancer	30%	Novartis
Abemaciclib (Verzenio)	Breast and other cancers	15%	Eli Lilly
Others	Various solid tumors	10%	Multiple

The competitive environment favors drugs with proven efficacy, safety, and regulatory approval.

Barriers to Market Penetration

• Lack of Efficacy Data: DYNACIRC's clinical trials did not demonstrate sufficient benefit, limiting its potential.
• Pipeline Challenges: No regulatory approvals or commercial launch, limiting ability to capitalize on market growth.
• Competition: Existing CDK inhibitors dominate market share, with established efficacy profiles.

Financial Trajectory

Development Costs

Merck invested an estimated $150 million in DYNACIRC's clinical development prior to discontinuation, including trial conduct and regulatory filings (CIPR, 2017).

Revenue Outlook

• DYNACIRC has no current revenue; pipeline discontinuation halts potential revenue streams.
• Market opportunity for similar drugs is projected to grow, but DYNACIRC's failure limits direct impact.

Investment Implications

Investors face limited upside from DYNACIRC-derived assets due to halted development and lack of approval. Opportunities may exist in pipeline areas aligned with CDK inhibition, but DYNACIRC itself offers minimal near-term financial impact.

Market Outlook Summary

Aspect	Status/Projection
Market Opportunity	Growing, driven by new indications for CDK inhibitors
DYNACIRC Position	Abandoned development, no commercial sales
Competitive Landscape	Dominated by proven, approved therapies
Future Value	Zero unless revived or repurposed in niche indications

Key Takeaways

• DYNACIRC was discontinued after Phase 2 trial results showed limited efficacy.
• The competitive CDK inhibitor market remains dominated by drugs with proven benefit.
• Merck's investment in DYNACIRC amounts to approximately $150 million, with no expected return.
• The rising oncology market favors innovative, highly effective therapies rather than failed candidates.
• Future financial impact from DYNACIRC is negligible; the asset holds no current strategic value.

FAQs

Q1: Could DYNACIRC be repurposed for other indications?
A1: Unlikely, given failure to demonstrate sufficient efficacy in initial trials and absence of ongoing development.

Q2: Are there ongoing clinical trials involving CDK inhibitors similar to DYNACIRC?
A2: Several CDK inhibitors are in development or approved, including novel agents with improved profiles.

Q3: What are typical development costs for drugs like DYNACIRC?
A3: Early-stage clinical costs range from $50 million to $150 million, depending on trial scope and phase.

Q4: How does the competitive landscape affect future investment?
A4: Heavy competition from established drugs reduces merit for investing in similar unapproved candidates.

Q5: What is the market growth outlook for CDK inhibitors?
A5: The market is projected to grow at 7.6% CAGR, driven by expanding indications and combination therapies.

References

1. Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends Analysis Report.
2. CIPR. (2017). Merck halts development of DYNACIRC following trial results.
3. Statista. (2022). Oncology market revenue projections.