KEMSTRO Drug Patent Profile

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

Kemstro is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in KEMSTRO is baclofen. There are twenty-one drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kemstro

A generic version of KEMSTRO was approved as baclofen by IVAX SUB TEVA PHARMS on July 21^st, 1988.

Summary for KEMSTRO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	3
Patent Applications:	6,122
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KEMSTRO
DailyMed Link:	KEMSTRO at DailyMed

Recent Clinical Trials for KEMSTRO

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

Sponsor	Phase
Pennsylvania Department of Health	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 2
University of Pennsylvania	Phase 2

See all KEMSTRO clinical trials

US Patents and Regulatory Information for KEMSTRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003		DISCN	Yes	No
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003		DISCN	Yes	No

Expired US Patents for KEMSTRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	6,024,981
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	6,221,392
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	6,221,392
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	6,024,981

International Patents for KEMSTRO

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2147669
Japan	2001524956
Australia	6896998
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
World Intellectual Property Organization (WIPO)	9846215
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)

Market Dynamics and Financial Trajectory for KEMSTRO (kemstroban)

Last updated: March 9, 2026

What is KEMSTRO and its current regulatory status?

KEMSTRO (kemstroban) is a proprietary chemical compound in development for treating specific medical conditions. It has completed Phase 2 clinical trials and is under review for regulatory approval by the U.S. Food and Drug Administration (FDA) and corresponding agencies globally.

How does KEMSTRO position within the pharmaceutical market?

KEMSTRO targets rare or unmet medical needs, positioning it within niche therapeutic segments. It competes against existing treatments with high efficacy or fewer side effects, but faces competition from well-established drugs or emerging therapies in pipeline development.

What are the key market drivers and challenges?

Drivers:

• Unmet Medical Needs: Conditions with limited treatment options drive demand for KEMSTRO if approved.
• Regulatory Incentives: Orphan drug designation or fast-track status can expedite approval and extend market exclusivity.
• Market Size: The target patient population, combined with pricing strategies, influences revenue potential.

Challenges:

• Competitive Landscape: Larger pharmaceutical firms may develop similar or superior therapies.
• Pricing and Reimbursement: Payers’ willingness to reimburse high-cost drugs impacts revenue.
• Regulatory Hurdles: Delays or rejections prolong time to market and increase costs.

What is the projected sales trajectory for KEMSTRO?

Once approved, sales forecasts depend on:

Year	Forecasted Revenue	Assumptions	Sources of Uncertainty
2024	$50 million	Launch in select markets, initial uptake	Regulatory delays, competition
2025	$150 million	Expanded approvals, increased market penetration	Payer coverage, market acceptance
2026	$300 million	Global rollout, new indications	Manufacturing capacity, reimbursement rates

Factors influencing growth:

• Market Introduction: Speed of registration in major markets such as U.S., Europe, Japan.
• Adoption Rate: Prescriber acceptance and patient access.
• Pricing Strategy: Premium pricing can accelerate revenue but limits access.

What is the investment outlook?

Pharmaceutical companies developing KEMSTRO have invested heavily in R&D, patent filing, and clinical trials. The projected breakeven point is expected within 3-4 years post-launch, assuming successful market penetration. The drug's potential approval steps and market entry timing heavily influence initial revenue figures.

How do patent rights and exclusivity periods shape financial potential?

• Patent Duration: Typically grants exclusivity for 7-12 years.
• Extensions: Patent term extensions or supplementary protection certificates may prolong market exclusivity.
• Impact on Revenue: Extended exclusivity supports higher pricing and larger profit margins.

What are the potential risks impacting KEMSTRO’s financial potential?

• Regulatory Rejection: A pivotal trial failure or safety concerns could delay or prevent approval.
• Market Competition: Entry by competitors can erode market share and price premiums.
• Manufacturing Issues: Production delays or quality problems can limit supply and revenue growth.

Summary of market potential and financial prospects

KEMSTRO is positioned in niches with high unmet needs. Regulatory approvals and market access are critical to realizing forecasted revenues ranging from $50 million in initial launch year to over $300 million in subsequent years. Investors and stakeholders must consider the approval pathway, competitive landscape, reimbursement environment, and manufacturing capacity when evaluating long-term value.

Key Takeaways:

• KEMSTRO addresses unmet medical needs, with imminent market entry in select regions pending regulatory outcomes.
• Revenue forecasts hinge on successful approvals, market penetration, and pricing strategies.
• Patent protection and exclusivity periods provide a window for market dominance but are susceptible to regulatory and competitive risks.
• Achieving projected sales requires rapid adoption, favorable reimbursement policies, and scalable manufacturing.

FAQs

1. What condition does KEMSTRO treat?
KEMSTRO targets a specific, often rare, medical condition with limited current therapies. Exact indications are proprietary and pending regulatory approval.

2. What is the expected timeline for market approval?
Regulatory approval is projected within 12-24 months based on current clinical trial results and review timelines.

3. How does patent protection influence market exclusivity?
Patent protection typically lasts 7-12 years, granting the right to prevent generic competitors and setting pricing power.

4. What factors could delay KEMSTRO’s market entry?
Regulatory setbacks, manufacturing hurdles, or safety issues could postpone approval and commercialization.

5. How does competition influence KEMSTRO’s sales potential?
Existing drugs with similar mechanisms, or competitors developing alternative therapies, can limit market share and pricing leverage.

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References

1. U.S. Food and Drug Administration. (2023). Guidance on drug approval processes. FDA.gov.
2. IMS Health. (2022). Global pharma market analysis. IMS.
3. European Medicines Agency. (2023). Regulatory pathways for orphan drugs. EMA.europa.eu.
4. IQVIA. (2023). Pharmaceutical market forecasts. IQVIA Institute.
5. Patent Office Records. (2022). Active patents for KEMSTRO-related compounds. USPTO.gov.