Last Updated: August 3, 2026

K-LEASE Drug Patent Profile


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Which patents cover K-lease, and when can generic versions of K-lease launch?

K-lease is a drug marketed by Savage Labs and is included in two NDAs.

The generic ingredient in K-LEASE is potassium chloride. There are two hundred and forty drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for K-lease

A generic version of K-LEASE was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

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Questions you can ask:
  • What is the 5 year forecast for K-LEASE?
  • What are the global sales for K-LEASE?
  • What is Average Wholesale Price for K-LEASE?
Summary for K-LEASE
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 250
Patent Applications: 3,614
DailyMed Link:K-LEASE at DailyMed

US Patents and Regulatory Information for K-LEASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs K-LEASE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 073398-001 Jan 28, 1992 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Savage Labs K-LEASE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 072427-001 Mar 28, 1990 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
Last updated: July 28, 2026

K-LEASE (K-LEASE drug): Market dynamics and financial trajectory

K-LEASE has insufficient publicly indexed identifiers (active ingredient, strength, dosage form, sponsor/labeler, FDA approvals, and revenue disclosures). Without the underlying drug identity, no reliable market-dynamics or financial-trajectory analysis can be produced in a way that is complete and accurate.

What is K-LEASE and what active ingredient does it contain?

Featured-snippet answer: K-LEASE’s active ingredient, strength, dosage form, and regulatory identity are not specified in the available information, preventing mapping to FDA product records, pricing datasets, or sales disclosures.

Which labeler, manufacturer, and marketer are listed for K-LEASE?

No sponsor/labeler and no manufacturer chain is identifiable for K-LEASE.

Is K-LEASE an Rx drug, OTC product, or hospital-only therapy?

No classification data is available to determine the channel mix.

What patents protect K-LEASE and what does that mean for pricing power?

Featured-snippet answer: Patent estate mapping for K-LEASE cannot be performed because the drug identity and FDA Orange Book entry cannot be established.

How many patents are in the Orange Book for K-LEASE?

No Orange Book listing can be confirmed without an identifiable active ingredient and FDA application number.

What are the likely exclusivity drivers for K-LEASE?

No exclusivity basis (NCE, 5-year, 3-year, pediatric, or orphan exclusivity) can be determined without the FDA approval record.

When does K-LEASE lose exclusivity and when could generic competition enter?

Featured-snippet answer: Exclusivity and generic entry timelines cannot be calculated without the FDA approval date and Orange Book patent/Orange Book exclusivity codes.

What Paragraph IV challenges exist for K-LEASE?

No publicly verifiable Paragraph IV litigation record can be tied to K-LEASE.

What is the Orange Book status of K-LEASE?

Status cannot be determined without a verified Orange Book product identifier.

What is the FDA regulatory status of K-LEASE (approval date, NDA/BLA, and pathway)?

Featured-snippet answer: Regulatory status cannot be stated because K-LEASE’s FDA product identity and application type are not provided.

Is K-LEASE approved for which indications and what is the line-of-therapy placement?

No indication list is available.

Does K-LEASE have REMS, risk controls, or special prescribing requirements?

No REMS data is available.

How does K-LEASE compete in its therapeutic class and what are the key market dynamics?

Featured-snippet answer: Competitive dynamics cannot be modeled without the therapeutic class, mechanism of action, route, and approved indications.

Who are the closest competitors to K-LEASE (brand and generic alternatives)?

No competitor mapping can be created without the drug’s identity.

What drives demand for K-LEASE (incidence, reimbursement, utilization, switching)?

No demand drivers can be quantified without indication and payer/reimbursement context.

What is the financial trajectory for K-LEASE: revenue, growth, and margins?

Featured-snippet answer: No reliable financial trajectory can be produced because K-LEASE’s commercial identity is not mapped to public financial statements, unit sales datasets, or payer reporting.

Has K-LEASE been commercially launched, and in what geographies?

Launch timing and geography cannot be confirmed.

What revenue sources exist for K-LEASE (US vs ex-US, hospital vs retail, wholesaler vs direct)?

Channel and geography splits cannot be stated.

What does historical pricing show for K-LEASE?

Pricing trend analysis requires NDC/strength/formulation identifiers.

Which companies control K-LEASE and what licensing or distribution arrangements exist?

Featured-snippet answer: No controller company or licensing/distribution structure can be identified for K-LEASE based on the provided information.

Are there co-promotion, manufacturing, or commercialization partnerships?

No partnership data is available.

Key Takeaways

  • K-LEASE cannot be analyzed for market dynamics or financial trajectory without a verifiable drug identity (active ingredient, FDA application/product, and labeler).
  • Patent-exclusivity timelines, Paragraph IV risk, regulatory pathway, competitor set, and revenue/margin trajectory cannot be produced in a complete and accurate manner.

FAQs

  1. How can K-LEASE’s FDA approval be verified for market analysis?
  2. What Orange Book and exclusivity milestones would typically constrain generic entry for a drug like K-LEASE?
  3. What data sources show unit sales and prescriptions for K-LEASE by NDC and strength?
  4. How do biosimilar or generic substitutes typically shift revenue in the same therapeutic class as K-LEASE?
  5. What patent litigation indicators usually predict settlement vs trial outcomes for brand drugs like K-LEASE?

References (APA)

No sources cited because K-LEASE cannot be uniquely identified for Orange Book, FDA, litigation, or financial datasets from the provided information.

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