CLOROTEKAL Drug Patent Profile

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

Clorotekal is a drug marketed by B Braun Medical Inc and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty-seven countries.

The generic ingredient in CLOROTEKAL is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clorotekal

A generic version of CLOROTEKAL was approved as chloroprocaine hydrochloride by HIKMA on September 9^th, 1998.

Summary for CLOROTEKAL

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	766
Drug Prices:	Drug price information for CLOROTEKAL
What excipients (inactive ingredients) are in CLOROTEKAL?	CLOROTEKAL excipients list
DailyMed Link:	CLOROTEKAL at DailyMed

See drug prices for CLOROTEKAL

Recent Clinical Trials for CLOROTEKAL

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

Sponsor	Phase
Oregon Health and Science University	Phase 4
B. Braun Medical Inc.	Phase 4
University of Alabama at Birmingham	Phase 2

See all CLOROTEKAL clinical trials

Pharmacology for CLOROTEKAL

Drug Class	Ester Local Anesthetic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for CLOROTEKAL

CLOROTEKAL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	8,969,412		Y
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	9,504,666		Y

International Patents for CLOROTEKAL

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1931304
Serbia	53077	NOVA UPOTREBA ZA KOMPOZICIJU KOJA SADRŽI HLOROPROKAIN HCL, NOVA KOMPOZICIJA KOJA SADRŽI HLOROPROKAIN HCL I POSTUPAK ZA NJENU PROIZVODNJU (NEW USE FOR A COMPOSITION COMPRISING CHLOROPROCAINE HCL, A NEW COMPOSITION COMPRISING CHLOROPROCAINE HCL AND A METHOD FOR ITS MANUFACTURE)
Cyprus	1114743
Israel	239270	תכשיר המכיל כלורופרוקאין ומשמש למתן אינטרטכלי רב פעמי (Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration)

CLOROTEKAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLOROTEKAL

Introduction

CLOROTEKAL, a brand name for chloroprocaine hydrochloride, is an ester local anesthetic approved by the FDA for intrathecal injection in adults to produce subarachnoid block (spinal anesthesia). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global anesthesia drugs market, within which CLOROTEKAL operates, is projected to grow significantly. As of 2022, the global anesthesia drugs market was valued at USD 6.07 billion and is expected to reach USD 8.20 billion by 2031, growing at a CAGR of 4.4% during the forecast period (2023-2031)[1].

Regional Market Performance

• North America: This region is the most significant revenue contributor to the anesthesia drugs market and is expected to exhibit a CAGR of 3.60% during the forecast period. The United States, in particular, dominates this market due to an aging population and an increase in chronic diseases[1].
• Europe: Europe is expected to exhibit a CAGR of 3.40% during the forecast period. The rise in surgical procedures, especially for orthopedic conditions and other general surgeries, drives the market in this region[1].

Segmentation and Market Share

• General Anesthesia Drugs: This segment is the major contributor to the market, estimated to exhibit a CAGR of 3.70% during the forecast period. The growth is driven by the rising prevalence of emergency operations, an aging population, and increased surgical procedures[1].
• Injection Segment: The injection segment, which includes drugs like CLOROTEKAL, owns the highest market share and is estimated to exhibit a CAGR of 3.75% during the forecast period[1].

Product Approval and Launch

CLOROTEKAL was approved by the FDA on September 26, 2017, and is manufactured by B. Braun Medical Inc. It was specifically designed for fast-track spinal anesthesia in day surgery cases, enhancing recovery after surgery[3][4].

Clinical Trials and Safety Profile

• Clinical Trials: CLOROTEKAL was tested in clinical trials involving 111 patients undergoing various surgical procedures. The most common adverse reactions included procedural pain, injection site pain, and hypotension. Less common reactions included anesthetic complications, nausea, headache, and hyperglycemia[2].
• Safety Profile: The drug is associated with potential side effects such as high or total spinal block, leading to cardiovascular and respiratory depression. Careful monitoring of patients is recommended after administration[2].

Market Drivers

• Increasing Surgical Procedures: The rise in surgical procedures, particularly cesarean sections, cardiac surgeries, and other chronic condition-related surgeries, drives the demand for anesthetic medications like CLOROTEKAL[1].
• Research and Development: Leading manufacturers' investments in research and development, including the approval of new generics, boost the market for these medications[1].
• Technological Advancements: Technological advancements in anesthesia, such as the introduction of new drugs like CLOROTEKAL, contribute to market growth[1].

Challenges and Considerations

• Geriatric Use: Patients over 65 years, especially those with hypertension, may be at increased risk of developing hypotension while undergoing spinal anesthesia with CLOROTEKAL. This necessitates careful patient selection and monitoring[2].
• Counterfeit Medications: There is a risk of fraudulent online pharmacies selling counterfeit versions of CLOROTEKAL, which can be potentially unsafe. Purchasing from reputable sources is crucial[4].

Future Outlook

• Innovation in Pain Relief: Companies like Sintetica, the developer of CLOROTEKAL, are working on radical innovations in pain relief after surgery. These innovations could significantly impact the way pain is managed both in hospitals and at home[3].
• Market Expansion: The growing demand for effective and safe anesthetic medications, coupled with advancements in medical technology, suggests a bright future for drugs like CLOROTEKAL.

Key Takeaways

• CLOROTEKAL operates within a growing global anesthesia drugs market projected to reach USD 8.20 billion by 2031.
• The drug is primarily used in North America and Europe, driven by increasing surgical procedures and technological advancements.
• CLOROTEKAL's safety profile includes potential side effects like hypotension and respiratory depression, necessitating careful patient monitoring.
• The market is driven by rising surgical procedures, R&D investments, and technological advancements.
• Future innovations in pain relief and safe medication practices are expected to further boost the market.

FAQs

Q: What is CLOROTEKAL used for? A: CLOROTEKAL is an ester local anesthetic used for intrathecal injection in adults to produce subarachnoid block (spinal anesthesia), particularly in day surgery cases.

Q: When was CLOROTEKAL approved by the FDA? A: CLOROTEKAL was approved by the FDA on September 26, 2017.

Q: What are the common adverse reactions associated with CLOROTEKAL? A: Common adverse reactions include procedural pain, injection site pain, and hypotension. Less common reactions include anesthetic complications, nausea, headache, and hyperglycemia.

Q: Which regions are the primary markets for CLOROTEKAL? A: North America and Europe are the primary markets, with North America being the most significant revenue contributor.

Q: What are the key drivers of the market for CLOROTEKAL? A: The key drivers include the rise in surgical procedures, investments in research and development, and technological advancements in anesthesia.

Cited Sources

1. Straits Research: "Anesthesia Drugs Market Size to Reach USD 8.20 Billion by 2031"
2. DailyMed: "Label: CLOROTEKAL- chloroprocaine hydrochloride injection, solution"
3. CIObulletin: "Sintetica: Where Everything is done to Achieve Scientific Leadership"
4. Drugs.com: "Generic Clorotekal Availability"