Last Updated: August 8, 2026

MYKROX Drug Patent Profile


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

Mykrox is a drug marketed by Chartwell Molecular and is included in one NDA.

The generic ingredient in MYKROX is metolazone. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mykrox

A generic version of MYKROX was approved as metolazone by SANDOZ on December 19th, 2003.

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AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for MYKROX?
  • What are the global sales for MYKROX?
  • What is Average Wholesale Price for MYKROX?
Summary for MYKROX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 76
Patent Applications: 4,474
DailyMed Link:MYKROX at DailyMed

US Patents and Regulatory Information for MYKROX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Molecular MYKROX metolazone TABLET;ORAL 019532-001 Oct 30, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MYKROX

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

Country Patent Number Title Estimated Expiration
Austria 53294 ⤷  Start Trial
Australia 2643484 ⤷  Start Trial
Australia 565640 ⤷  Start Trial
Canada 1216236 COMPOSES PHARMACEUTIQUES UNIFORMES SE DISSOLVANT RAPIDEMENT ET METHODE DE PREPARATION (RAPID DISSOLVING, UNIFORM DRUG COMPOSITIONS AND THEIR PREPARATION) ⤷  Start Trial
Switzerland 662947 SICH SCHNELL AUFLOESENDE, PHARMAZEUTISCHE ZUBEREITUNG SOWIE VERFAHREN ZU IHRER HERSTELLUNG. ⤷  Start Trial
Germany 3482402 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration
Last updated: July 17, 2026

MYKROX Market Dynamics and Financial Trajectory: Revenue Drivers, Competitive Pressure, and Exclusivity Timeline

MYKROX’ market trajectory is not determinable from the available information in this prompt. No drug strength, FDA product identifier, NDC, manufacturer, indication scope, pricing, sales history, or patent/Exclusivity timeline is provided, and the constraints prevent producing an accurate market-and-financial profile without those factual anchors.

What is MYKROX and what market does it address?

Answer: Not specified in the provided input.

What active ingredient and dosage form does MYKROX have?

Answer: Not specified in the provided input.

What therapeutic area and target patient population does MYKROX serve?

Answer: Not specified in the provided input.

Who manufactures MYKROX and how is it distributed?

Answer: Not specified in the provided input.

What are the key commercialization partners and channels?

Answer: Not specified in the provided input.

Is MYKROX sold direct, through wholesalers, or via specialty pharmacy?

Answer: Not specified in the provided input.

What is the Orange Book status of MYKROX?

Answer: Not specified in the provided input.

Which patents are listed for MYKROX (listed drug, NDA, and patent types)?

Answer: Not specified in the provided input.

Are there any granted exclusivities (NCE, 3-year, 5-year, pediatric, orphan)?

Answer: Not specified in the provided input.

When does MYKROX lose exclusivity and what is the patent expiration timeline?

Answer: Not specified in the provided input.

What are the earliest generic or biosimilar entry dates?

Answer: Not specified in the provided input.

What is the latest possible “hard” date for generic launch based on listed patents?

Answer: Not specified in the provided input.

What generic entry risks exist for MYKROX?

Answer: Not specified in the provided input.

Have any Paragraph IV certifications been filed?

Answer: Not specified in the provided input.

What settlement agreements shape generic timing?

Answer: Not specified in the provided input.

How strong is the patent estate for MYKROX?

Answer: Not specified in the provided input.

What formulation, method-of-use, or manufacturing patents cover MYKROX?

Answer: Not specified in the provided input.

How many patents protect the specific commercial product and strength?

Answer: Not specified in the provided input.

What patent litigation affects MYKROX?

Answer: Not specified in the provided input.

Which companies have challenged MYKROX?

Answer: Not specified in the provided input.

What is the current procedural posture (filed, stayed, in discovery, trial, appeal)?

Answer: Not specified in the provided input.

How does MYKROX compare with competing therapies (efficacy, safety, access)?

Answer: Not specified in the provided input.

What are the key competitors by mechanism of action?

Answer: Not specified in the provided input.

How does MYKROX price and reimbursement stack up versus alternatives?

Answer: Not specified in the provided input.

What are MYKROX pricing, net revenue, and margin dynamics?

Answer: Not specified in the provided input.

What is the gross-to-net path (rebates, chargebacks, copay assistance)?

Answer: Not specified in the provided input.

What is the trend in ASP or WAC and how sensitive is it to contracting?

Answer: Not specified in the provided input.

What financial trajectory does MYKROX show (sales history and outlook)?

Answer: Not specified in the provided input.

What has MYKROX revenue been over time (quarterly and annual)?

Answer: Not specified in the provided input.

What is the sales forecast sensitivity to exclusivity and competitive entry?

Answer: Not specified in the provided input.

How do launch and adoption dynamics drive MYKROX growth or decline?

Answer: Not specified in the provided input.

What is the adoption curve by prescriber type and geography?

Answer: Not specified in the provided input.

Is demand driven by brand awareness, formulary placement, or guideline status?

Answer: Not specified in the provided input.

Key Takeaways

  • MYKROX market dynamics and financial trajectory cannot be produced from the information provided.
  • No factual inputs are included for FDA status, patent/exclusivity posture, competitors, pricing, or sales history needed for an accurate market and financial profile.

FAQs

  1. What FDA pathway is MYKROX approved under (505(b)(1), 505(b)(2), or 351)?
  2. Which NDCs and strengths correspond to MYKROX as marketed in the U.S.?
  3. Are there any bioequivalence or interchangeability constraints affecting MYKROX generics?
  4. What payer policies most influence MYKROX net pricing (prior auth, step edits, quantity limits)?
  5. What is the earliest feasible generic entry date under the Orange Book and Hatch-Waxman framework?

References

(0 sources cited; none were provided in the prompt)

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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.