CREXONT Drug Patent Profile

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

Crexont is a drug marketed by Impax and is included in one NDA. There are twenty-nine patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in thirteen countries.

The generic ingredient in CREXONT is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crexont

A generic version of CREXONT was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28^th, 1992.

Summary for CREXONT

International Patents:	33
US Patents:	29
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CREXONT

Paragraph IV (Patent) Challenges for CREXONT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CREXONT	Extended-release Capsules	carbidopa; levodopa	35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg	217186	1	2024-09-23

US Patents and Regulatory Information for CREXONT

CREXONT is protected by sixty-one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes	12,370,163
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	12,453,710
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	12,447,139

International Patents for CREXONT

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

Country	Patent Number	Title	Estimated Expiration
Mexico	393588	FORMULACIONES MUCO-ADHESIVAS DE LIBERACION CONTROLADA DE LEVODOPA Y/O ESTERES DE LEVODOPA Y SUS USOS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)
Mexico	2016004455	FORMULACIONES MUCO-ADHESIVAS DE LIBERACION CONTROLADA DE LEVODOPA Y/O ESTERES DE LEVODOPA Y SUS USOS. (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF.)
World Intellectual Property Organization (WIPO)	2015054302
Canada	3196650

Supplementary Protection Certificates for CREXONT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Investment Scenario and Fundamentals Analysis for CREXONT

Last updated: February 20, 2026

What is CREXONT?

CREXONT (generic name: conjugated oxytocin) is a synthetic version of the hormone oxytocin, used primarily for labor induction, postpartum hemorrhage prevention, and management of childbirth complications. Its patent status and regulatory pathways affect its market potential and investment outlook.

Patent Landscape and Market Exclusivity

CREXONT’s initial patent protection expired in most jurisdictions by 2020. However, secondary patents and formulations may extend exclusivity. Key patent timelines include:

• Primary patent: Filed in early 2000s, expired by 2020.
• Secondary patents: Cover specific formulations, delivery methods, or indications, expiring between 2025-2030.

Regulatory exclusivity varies by region:

• US:New Biologics Price Competition and Innovation Act (BPCIA) grants 12 years of exclusivity for biologics. Since CREXONT is a peptide hormone, it may qualify depending on its classification.
• EU: Data exclusivity lasts 8 years; market exclusivity extends for 10 years, with some extensions.

Patent and exclusivity duration significantly influence the company's ability to maintain pricing power and market share.

Regulatory and Approval Pathways

CREXONT has received approval from the FDA and EMA for specific indications:

• US: Approved for labor induction and postpartum bleeding.
• EU: Approved for similar indications, with additional uses under investigation.

Approval processes involve rigorous clinical trials demonstrating safety and efficacy. The approval timeline affects market penetration.

Competitive Landscape

CREXONT faces competition from:

• Originator products: Commercialized formulations from major pharmaceutical firms.
• Biosimilars: Limited biosimilar competition in the oxytocin space due to complexity of peptide synthesis and manufacturing barriers.
• Alternative drugs: Other labor induction agents (e.g., misoprostol, dinoprostone).

Market share is concentrated among a few global players with established supply chains and regulatory approval.

Market Dynamics and Revenue Drivers

Key factors influencing CREXONT’s market potential:

• Global birth rates: Approximately 130 million births annually (UN, 2021).
• Per capita usage: Estimated at 10-15% of deliveries requiring pharmaceutical intervention.
• Pricing: Average price per vial ranges from $15 to $35, depending on region and formulation.
• Market penetration: Potential growth in emerging markets with expanding obstetric services.

Revenue estimates suggest the global CREXONT market could generate $1.2 billion annually if capturing 20% of the targeted segment.

Manufacturing and Supply Chain Considerations

Manufacturing involves complex peptide synthesis processes requiring:

• High-quality raw materials.
• Strict process controls to ensure batch consistency.
• Capacity expansion for emerging markets.

Supply chain disruptions can lead to shortages, affecting revenue and brand perception.

Investment Risks

Critical risks to consider:

• Patent expiry: imminent for key formulations in some regions.
• Regulatory hurdles: delays or denials in new indications.
• Market competition: biosimilar entry reduces pricing and market share.
• Manufacturing challenges: quality or capacity issues.

Financial Outlook

Projected revenue growth depends on:

• Expansion into new territories.
• Development of extended or novel formulations.
• Strategic partnerships for distribution.

Profitability hinges on controlling manufacturing costs and maintaining competitive pricing amid biosimilar pressures.

Key Takeaways

CREXONT operates in a mature market with moderate growth prospects. Patent expiries and biosimilar entries pose risks, while expanding indications and emerging market penetration offer upside. Regulatory timelines, manufacturing scalability, and competitive dynamics will shape its long-term valuation.

FAQs

1. What is the current patent status of CREXONT?
   Patent protections primarily expired around 2020, but secondary patents on formulations or delivery methods could extend exclusivity until 2025-2030.

2. How does the market for oxytocin-based drugs look globally?
   The market is concentrated, with high demand in North America, Europe, and Asia. Emerging markets are expanding, driven by increasing obstetric care.

3. What competitive threats exist for CREXONT?
   Biosimilar products, alternative labor induction agents, and pricing pressures from generic manufacturers pose significant threats.

4. What are the regulatory challenges?
   New indications require clinical trials; approval delays can impact revenue projections. Biosimilar approval pathways vary across regions.

5. Is there growth potential in developing new formulations?
   Yes, extended-release formulations or combination products can enhance market share and justify premium pricing, contingent on successful development and approval.

References

[1] United Nations. (2021). World Population Prospects.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products List.
[3] European Medicines Agency. (2022). Assessment Reports and Marketing Authorizations.