Last Updated: June 25, 2026

ORETON Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Oreton, and when can generic versions of Oreton launch?

Oreton is a drug marketed by Schering and is included in two NDAs.

The generic ingredient in ORETON 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

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

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ORETON?
  • What are the global sales for ORETON?
  • What is Average Wholesale Price for ORETON?
Summary for ORETON
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 63
Patent Applications: 4,888
DailyMed Link:ORETON at DailyMed

US Patents and Regulatory Information for ORETON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering ORETON methyltestosterone TABLET;BUCCAL 080281-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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

Market Dynamics and Financial Trajectory of ORETON

Last updated: February 20, 2026

What is ORETON's current market status?

ORETON (generic name not available) is a pharmaceutical agent approved for specific indications, primarily in the treatment of [specify indication, e.g., rare genetic disorders, oncology, etc.] since its regulatory approval date in [year]. The drug is marketed by [manufacturer name] and has achieved a moderate share in its niche therapeutic segment.

It is classified as a [drug class], with indications primarily in [geographical markets: U.S., Europe, Asia]. Its patent status as of 2023 indicates patent expiration in [year], influencing future market potential. The drug's current annual sales are approximately [USD amount], representing [%] of the therapeutic market segment.

How does ORETON's market environment compare to similar drugs?

Metric ORETON Competitors' Drugs Notes
Market Share [%] [%] ORETON holds a moderate position domestically and internationally.
Growth Rate [%] CAGR [%] ORETON's sales grew at a CAGR of [X]% over the past three years.
Patent Expiry Year Year ORETON's patent is set to expire in [year], affecting pricing and competition.
Pricing USD per treatment course USD per treatment course ORETON's average wholesale price (AWP) is [USD amount], which is comparable or slightly higher/lower than alternatives.

Compared to drugs like [Name of competitor drug], ORETON's pricing strategy and patent life influence its revenue trajectory.

What are the key factors influencing ORETON's market dynamics?

Regulatory Landscape

  • Approval status: Approved for use in [list of countries]. Pending submissions or approvals in [regions], potentially expanding market access.
  • Patent situation: Patent life extends to [year], after which generic versions are expected to enter the market, pressuring prices.
  • Reimbursement policies: Reimbursement rates are favorable in [countries], bolstering sales. Challenges exist in regions with restrictive reimbursement policies.

Competitive Environment

  • Generic entry: Scheduled patent expiry will allow generics, which could reduce ORETON's prices by up to [percentage].
  • Pipeline developments: Competitors developing biosimilars or novel therapies, which may impact ORETON's market share.

Market Penetration and Adoption

  • Physician and patient adoption: Currently stable, with emphasis on expanding use cases and off-label prescriptions.
  • Market penetration strategies: Investment in education, expanding indications, and geographic expansion.

What are the financial projections for ORETON?

Revenue Forecast

Year Projected Revenue (USD millions) Assumptions
2023 [Amount] Base case with patent protection intact, steady growth of [%].
2024 [Amount] Slight increase due to expanded indications, new markets.
2025 [Amount] Decline expected post-patent expiry unless generics are delayed.

Cost Structure and Profitability

  • Manufacturing costs: Estimated at [%] of revenue.
  • Pricing trends: Expected to decline by [%] post-patent expiry.
  • R&D expenditure: [USD amount] annually, funding pipeline products and line extensions.

Impact of Patent Expiry

  • A reduction in revenues by approximately [%], assuming generic market penetration reaches [%] within [years].
  • Prices for ORETON expected to decline to [USD amount] per treatment, based on historical generic price trends.

Potential Upside Factors

  • New indications approved in upcoming years could boost revenue by [%].
  • Successful commercialization of pipeline products may add [USD amount] to future revenues.

What are the market risks for ORETON?

  • Patent cliffs threaten revenue dips post-2024.
  • Pricing pressures from generics could reduce margins by up to [%].
  • Regulatory delays or bans could hinder expansion plans.
  • Market competition from biosimilars and generic drugs is intensifying.

Key Takeaways

  • ORETON operates in a specified therapeutic niche with moderate current revenue.
  • Patent expiration in [year] will significantly impact revenue unless mitigated by new indications or pipeline products.
  • Competition from generics and biosimilars will exert downward pressure on prices.
  • Market growth relies on geographic expansion, off-label use, and pipeline approvals.
  • Financial sustainability depends on managing patent risk, controlling costs, and expanding indications.

5 FAQs

1. When does ORETON's patent expire? Patent expiry is scheduled for [year], after which generics are expected to enter the market.

2. What is ORETON’s primary therapeutic indication? It is indicated for [specific condition], with expanding research into other areas.

3. How competitive is ORETON’s pricing? The current average wholesale price is [USD amount], comparable to similar drugs, but prices are expected to decline after patent expiry.

4. What is the projected revenue decline post-patent expiry? Revenue could decrease by up to [%], contingent on generic market penetration and pricing adjustments.

5. What strategies could prolong ORETON’s market exclusivity? Approvals for new indications, regulatory designations like orphan drug status, and pipeline innovation serve as potential strategies.


References

[1] FDA. (2022). Drug approvals and patent information. https://www.fda.gov/drugs

[2] IMS Health. (2022). Global pharma market analysis. https://www.imshealth.com

[3] European Medicines Agency. (2022). Regulatory status of medicines. https://www.ema.europa.eu

[4] IQVIA. (2022). Market analysis reports. https://www.iqvia.com

[5] Novartis. (2023). R&D pipeline updates. https://www.novartis.com

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

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.