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Last Updated: March 18, 2025

ANADROL-50 Drug Patent Profile


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Which patents cover Anadrol-50, and what generic alternatives are available?

Anadrol-50 is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in ANADROL-50 is oxymetholone. There is one drug master file entry for this compound. Additional details are available on the oxymetholone profile page.

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Summary for ANADROL-50
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 37
Patent Applications: 2,236
Drug Prices: Drug price information for ANADROL-50
What excipients (inactive ingredients) are in ANADROL-50?ANADROL-50 excipients list
DailyMed Link:ANADROL-50 at DailyMed
Drug patent expirations by year for ANADROL-50
Drug Prices for ANADROL-50

See drug prices for ANADROL-50

US Patents and Regulatory Information for ANADROL-50

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Norvium Bioscience ANADROL-50 oxymetholone TABLET;ORAL 016848-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for ANADROL-50

Introduction

ANADROL-50, known by its generic name oxymetholone, is a potent anabolic and androgenic steroid that has been on the market for several decades. Initially approved by the FDA for the treatment of certain types of anemia, it has also gained popularity in the bodybuilding and athletic communities for its muscle-building and performance-enhancing properties.

Historical Context and Approval

ANADROL-50 was approved by the FDA prior to January 1, 1982, for the treatment of anemias caused by deficient red cell production, including acquired and congenital aplastic anemia, myelofibrosis, and hypoplastic anemias due to myelotoxic drugs[4][5].

Market Availability and Discontinuation

The original brand name formulation of ANADROL-50 has been discontinued. All formulations of ANADROL-50, including the 50mg tablets, are no longer manufactured or distributed by the original manufacturer. However, generic versions may still be available, although caution is advised due to the risk of counterfeit medications[1].

Medical Uses and Indications

ANADROL-50 is indicated for the treatment of specific medical conditions, primarily related to anemia. It helps in increasing red blood cell production, which is crucial for patients suffering from conditions like aplastic anemia and myelofibrosis. Despite its medical uses, it is not a replacement for other supportive measures such as transfusions, iron, folic acid, and vitamin B12 corrections[4][5].

Performance Enhancement and Bodybuilding

In the realm of bodybuilding and athletics, ANADROL-50 is highly sought after for its anabolic properties. It increases protein synthesis, nitrogen retention, and red blood cell production, leading to significant gains in muscle mass, strength, and endurance. However, its use in this context is not FDA-approved and carries significant health risks[2].

Side Effects and Risks

The use of ANADROL-50 is associated with several serious side effects, including liver toxicity, hepatocellular carcinoma, cardiovascular risks, testosterone suppression, and androgenic effects. These risks necessitate cautious use under professional supervision and highlight the importance of monitoring liver function, blood pressure, and other health parameters[2][4][5].

Financial Trajectory

Given the discontinuation of the original brand name formulation and the availability of generic versions, the financial trajectory of ANADROL-50 is complex.

  • Revenue Decline: With the discontinuation of the branded product, the revenue generated from ANADROL-50 sales has likely declined significantly.
  • Generic Market: The presence of generic versions, although risky due to potential counterfeiting, may still generate some revenue. However, this market is highly unpredictable and subject to regulatory scrutiny.
  • Black Market: The demand from bodybuilders and athletes drives a black market for ANADROL-50, which is not reflected in official financial reports but contributes to its ongoing presence in certain circles.

Regulatory Environment

ANADROL-50 is classified as a Schedule III controlled substance, indicating its potential for abuse and dependence. This classification affects its distribution, prescription, and use, further influencing its financial trajectory. Regulatory bodies closely monitor its use, especially in non-medical contexts, which can impact sales and revenue[4].

Competitive Landscape

The anabolic steroid market is competitive, with several other steroids available for both medical and non-medical use. The discontinuation of ANADROL-50 has likely shifted market share to other anabolic steroids, making the competitive landscape challenging for any remaining generic or black market versions.

Consumer Awareness and Safety

Consumer awareness about the risks associated with ANADROL-50 has increased, partly due to regulatory warnings and public health campaigns. This increased awareness can further reduce legitimate demand and revenue.

Key Takeaways

  • Discontinued Brand: The original ANADROL-50 formulation is no longer available.
  • Generic and Black Market: Generic versions and black market sales continue, but with significant risks.
  • Regulatory Scrutiny: Classified as a Schedule III controlled substance, with strict regulations.
  • Health Risks: Associated with serious side effects, impacting its use and revenue.
  • Competitive Market: The anabolic steroid market is highly competitive, affecting ANADROL-50's market share.

FAQs

Q: What is ANADROL-50 used for? A: ANADROL-50 is used to treat certain types of anemia caused by deficient red cell production and is also used off-label for muscle building and performance enhancement.

Q: Why was ANADROL-50 discontinued? A: The original brand name formulation of ANADROL-50 has been discontinued, although generic versions may still be available.

Q: What are the side effects of ANADROL-50? A: ANADROL-50 is associated with liver toxicity, hepatocellular carcinoma, cardiovascular risks, testosterone suppression, and androgenic effects.

Q: Is ANADROL-50 a controlled substance? A: Yes, ANADROL-50 is classified as a Schedule III controlled substance due to its potential for abuse and dependence.

Q: How should ANADROL-50 be used? A: ANADROL-50 should be used under professional supervision, following recommended dosages and cycle lengths, and with close monitoring of health parameters.

Cited Sources

  1. Drugs.com - Generic Anadrol-50 Availability
  2. NTE Energy - Anadrol 50: Unleashing Maximum Muscles
  3. FDA - ANADROL®-50 (oxymetholone) 50 mg Tablets
  4. Drugs.com - Anadrol: Package Insert / Prescribing Information
  5. RxList - Anadrol-50 (Oxymetholone): Side Effects, Uses, Dosage ...

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