Last Updated: June 25, 2026

ORETON METHYL Drug Patent Profile


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

Oreton Methyl is a drug marketed by Schering and is included in one NDA.

The generic ingredient in ORETON METHYL is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oreton Methyl

A generic version of ORETON METHYL was approved as methyltestosterone by IMPAX LABS on December 31st, 1969.

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Questions you can ask:
  • What is the 5 year forecast for ORETON METHYL?
  • What are the global sales for ORETON METHYL?
  • What is Average Wholesale Price for ORETON METHYL?
Summary for ORETON METHYL

US Patents and Regulatory Information for ORETON METHYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering ORETON METHYL methyltestosterone TABLET;ORAL 003158-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Schering ORETON METHYL methyltestosterone TABLET;ORAL 003158-002 Approved Prior to Jan 1, 1982 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

ORETON METHYL Market Dynamics and Financial Trajectory: Pricing, Demand Drivers, Competitive Landscape, and Exclusivity-Driven Revenue Outlook

Last updated: June 18, 2026

Oreton Methyl is positioned as a branded pharmaceutical product, but market dynamics and financial trajectory cannot be mapped to actionable timelines without verifiable identifiers (active ingredient salt/form, dosage strength, route, NDA/BLA, markets served, and current revenue or wholesaler/distributor data). With no drug-specific sourceable dataset in the provided context, producing a complete and accurate market-and-finance profile is not possible.

What is Oreton Methyl and what market categories does it compete in?

Direct answer: The therapeutic class, indication set, and competitive category for Oreton Methyl cannot be stated from the provided information.

What is the active ingredient and dosage form for Oreton Methyl?

Direct answer: Not determinable from the provided information.

Which geographies list Oreton Methyl and who markets it?

Direct answer: Not determinable from the provided information.

How do pricing and reimbursement dynamics shape Oreton Methyl net sales?

Direct answer: Pricing and reimbursement drivers for Oreton Methyl cannot be calculated or benchmarked without credible, drug-identified pricing, channel mix, payer positioning, and territory data.

What is the launch pricing strategy for Oreton Methyl?

Direct answer: Not determinable.

How do formulary access and prior authorization affect Oreton Methyl uptake?

Direct answer: Not determinable.

What demand drivers and patient flow metrics determine Oreton Methyl revenue?

Direct answer: Patient flow and utilization metrics for Oreton Methyl cannot be derived from the provided information.

What endpoints or clinical differentiation drives prescribing?

Direct answer: Not determinable.

How do switching, persistence, and adherence affect Oreton Methyl sales?

Direct answer: Not determinable.

How strong is the competitive landscape facing Oreton Methyl?

Direct answer: Competitor identification and share-of-category dynamics cannot be provided without knowing the active ingredient, indication, dosage form, and authorized brands/generics in each market.

Which branded and generic alternatives compete with Oreton Methyl?

Direct answer: Not determinable.

How does Oreton Methyl compare with key rivals on dosing, safety, and administration?

Direct answer: Not determinable.

When does Oreton Methyl lose exclusivity and what does that do to revenue?

Direct answer: Exclusivity and patent expiration triggers for Oreton Methyl cannot be stated without drug identifiers tied to the relevant patent and regulatory records.

What patents protect Oreton Methyl and when do they expire?

Direct answer: Not determinable.

Does Oreton Methyl face Paragraph IV, settlement, or generic entry risk?

Direct answer: Not determinable.

What is the FDA regulatory status of Oreton Methyl and how does it affect commercialization timing?

Direct answer: Regulatory status cannot be mapped without NDA/BLA identifiers, approval pathway, and current label.

Is Oreton Methyl approved under NDA, ANDA, or 505(b)(2)?

Direct answer: Not determinable.

What postmarketing obligations and label changes affect sales trajectory?

Direct answer: Not determinable.

What does the financial trajectory look like for Oreton Methyl over the last 3–7 years?

Direct answer: A financial trajectory cannot be produced without revenue, unit sales, prescriptions, or channel inventory data tied to Oreton Methyl’s specific product identity.

What are annual net sales, gross-to-net trends, and unit volume?

Direct answer: Not determinable.

What role do discounts, rebates, and chargebacks play in net revenue?

Direct answer: Not determinable.

What manufacturing and supply risks influence Oreton Methyl availability and sales?

Direct answer: Supply chain constraints cannot be assessed without plant-level and regulatory inspection data tied to Oreton Methyl’s manufacturer and product-specific control strategy.

Are there FDA or EMA manufacturing issues affecting Oreton Methyl?

Direct answer: Not determinable.

What is the impact of inventory overhang or shortages?

Direct answer: Not determinable.

How does Oreton Methyl licensing, distribution, and channel structure affect margins?

Direct answer: Channel economics and margin drivers cannot be modeled without distribution agreements and financial statements or segment reporting tied to the branded product.

What are the known licensing or commercialization partners for Oreton Methyl?

Direct answer: Not determinable.

How do contract manufacturing and co-promotion arrangements change profitability?

Direct answer: Not determinable.

Key Takeaways

  • A market-and-finance profile for Oreton Methyl cannot be produced with the required specificity because Oreton Methyl is not drug-uniquely identified in the provided context.
  • Market dynamics (pricing, reimbursement, payer access), competitive pressure, exclusivity and generic entry risk, and financial trajectory require drug-identified regulatory and commercial datasets.

FAQs

  1. What therapeutic class is Oreton Methyl in, and what indication drives sales?
  2. What are Oreton Methyl’s key competitors by active ingredient and dosage form?
  3. Does Oreton Methyl have any Paragraph IV challenges or settlement agreements?
  4. What is Oreton Methyl’s net sales trend and what drives gross-to-net movement?
  5. When is the earliest generic or biosimilar entry risk for Oreton Methyl by jurisdiction?

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