Last Updated: June 25, 2026

CLOROTEKAL Drug Patent Profile


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

Clorotekal is a drug marketed by B Braun Medical 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. Five suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

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Summary for CLOROTEKAL
International Patents:31
US Patents:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 2
Patent Applications: 865
Drug Prices: Drug price information for CLOROTEKAL
What excipients (inactive ingredients) are in CLOROTEKAL?CLOROTEKAL excipients list
DailyMed Link:CLOROTEKAL at DailyMed
Drug patent expirations by year for CLOROTEKAL
Drug Prices for CLOROTEKAL

See drug prices for CLOROTEKAL

Recent Clinical Trials for CLOROTEKAL

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

SponsorPhase
Oregon Health and Science UniversityPhase 4
B. Braun Medical Inc.Phase 4
University of Alabama at BirminghamPhase 2

See all CLOROTEKAL clinical trials

US Patents and Regulatory Information for CLOROTEKAL

CLOROTEKAL is protected by two US patents.

Glossary
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 CLOROTEKAL chloroprocaine hydrochloride SOLUTION;INTRATHECAL 208791-001 Sep 26, 2017 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
B Braun Medical CLOROTEKAL chloroprocaine hydrochloride SOLUTION;INTRATHECAL 208791-001 Sep 26, 2017 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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International Patents for CLOROTEKAL

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

Country Patent Number Title Estimated Expiration
Brazil PI0615702 novo uso para uma composição compreendendo cloroprocaìna hc1, uma nova composição compreendendo cloroprocaìna hc1, e um método para sua manufatura ⤷  Start Trial
Canada 2621015 NOUVELLE UTILISATION D'UNE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE, UNE NOUVELLE COMPOSITION COMPRENANT DU CHLORHYDRATEDE CHLOROPROCAINE ET UN PROCEDE PERMETTANTDE LA FABRIQUER (NEW USE FOR A COMPOSITION COMPRISING CHLOROPROCAINE HCL, A NEW COMPOSITION COMPRISING CHLOROPROCAINE HCL AND A METHOD FOR ITS MANUFACTURE) ⤷  Start Trial
Cyprus 1114743 ⤷  Start Trial
Denmark 1931304 ⤷  Start Trial
European Patent Office 1931304 NOUVELLE UTILISATION D'UNE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE, UNE NOUVELLE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE ET UN PROCEDE PERMETTANT DE LA FABRIQUER (NEW USE FOR A COMPOSITION COMPRISING CHLOROPROCAINE HCL, A NEW COMPOSITION COMPRISING CHLOROPROCAINE HCL AND A METHOD FOR ITS MANUFACTURE) ⤷  Start Trial
Spain 2441790 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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Last updated: June 8, 2026

CLOROTEKAL market dynamics and financial trajectory: sales outlook, payer pressure, and patent/generic risks

CLOROTEKAL market dynamics are not assessable from available public inputs in a way that supports a complete, accurate financial trajectory and competitive timeline.

No authoritative dataset in this workspace provides CLOROTEKAL-specific: FDA approval status and exclusivity dates, Orange Book/Biologics-related records, patent estate and litigation records, unit and revenue sales history, pricing, wholesaler distribution, or payer coverage/PA policies. Without those anchored facts, any revenue outlook, generic timing, or IP-driven market-share modeling would be speculative.

What is CLOROTEKAL’s FDA status and Orange Book exclusivity profile?

Answer: Not provided in the available inputs.

Which label, dosage forms, and strengths does CLOROTEKAL use?

Answer: Not provided in the available inputs.

Does CLOROTEKAL have patent-listed “drug product” and “method of use” entries?

Answer: Not provided in the available inputs.

What patents protect CLOROTEKAL and when do they expire?

Answer: Not provided in the available inputs.

How many patents cover the CLOROTEKAL drug product and the method of use?

Answer: Not provided in the available inputs.

What is the expiration timeline by patent number for CLOROTEKAL?

Answer: Not provided in the available inputs.

What is CLOROTEKAL’s generic entry risk from Paragraph IV challenges?

Answer: Not provided in the available inputs.

Have any ANDA Paragraph IV filings been made for CLOROTEKAL?

Answer: Not provided in the available inputs.

What settlement agreements impact CLOROTEKAL generic launch timing?

Answer: Not provided in the available inputs.

What generic or biosimilar competitors exist for CLOROTEKAL and what shares can they take?

Answer: Not provided in the available inputs.

Which companies are marketing or seeking to market CLOROTEKAL equivalents?

Answer: Not provided in the available inputs.

How does CLOROTEKAL’s clinical differentiation affect formulary placement?

Answer: Not provided in the available inputs.

How do pricing, rebates, and payer policies shape CLOROTEKAL demand?

Answer: Not provided in the available inputs.

What payer coverage patterns drive CLOROTEKAL volume (commercial vs Medicare vs Medicaid)?

Answer: Not provided in the available inputs.

Does CLOROTEKAL face step edits, prior authorization, or quantity limits?

Answer: Not provided in the available inputs.

What is CLOROTEKAL’s financial trajectory: historical revenue, margins, and guidance signals?

Answer: Not provided in the available inputs.

What are CLOROTEKAL sales by year and by channel (wholesale, specialty pharmacy, hospital)?

Answer: Not provided in the available inputs.

What is the unit trend versus price trend for CLOROTEKAL?

Answer: Not provided in the available inputs.

How does CLOROTEKAL’s supply chain and manufacturing economics affect gross margin?

Answer: Not provided in the available inputs.

Are there known manufacturing constraints, quality events, or contract dependencies?

Answer: Not provided in the available inputs.

Key Takeaways

  • A complete, accurate market dynamics and financial trajectory assessment for CLOROTEKAL cannot be produced from the available inputs because core anchors (FDA/Orange Book, patent estate, litigation, competitor landscape, and sales/pricing data) are not present.
  • Any projected revenue path, generic substitution timing, or IP-driven decline/increase would be speculative without those anchored facts.

FAQs

  1. What is CLOROTEKAL’s FDA approval date and current regulatory status (Rx/OTC, listed vs withdrawn)?
  2. What does CLOROTEKAL’s Orange Book listing show for patents and exclusivity end dates?
  3. Are there active ANDA Paragraph IV cases that could accelerate CLOROTEKAL generic launch?
  4. Which payer formularies and benefit designs most affect CLOROTEKAL access and uptake?
  5. What have CLOROTEKAL’s net sales and gross margin trends been over the past 3 to 5 years?

References

No sources were cited because none were available in the provided inputs.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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