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 Dr. Lee is the founder and owner of Regrowth LLC, a company based in Los Angeles and dedicated to the treatment of hair loss. He has been developing innovative products and treating hair loss sufferers for the past 16 years. Dr. Lee is the creator of the Xandrox line of hair loss treatments.
Important Note: Due a busy schedule, Dr. Lee cannot answer any new questions at this time; however, he will be providing high quality answers to questions he receives from his own practice exclusively to Morphollica.com regularly
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2004-02-13
Generic 5% Minoxidil vs. Rogaine Extra Strength
Do I understand correctly that generic 5% minoxidil solutions are the same as Rogaine for Men Extra Strength? Please let me know because the generic versions are a whole lot cheaper than the name brand.
The Upjohn Company had an exclusive patent on minoxidil solutions for the treatment of male pattern baldness, which expired on 13 February 1996. Thereafter, the FDA granted Upjohn market exclusivity for Rogaine Extra Strength (5% minoxidil) for several years, before allowing two other pharmaceutical companies to market generic versions. Although many brands of 5% minoxidil solutions are available, they may be made by the same pharmaceutical company and sold under different brand names.
Here are some paragraphs from the Federal Food and Drug Administration Center for Drug Evaluation and Research:
A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, and route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions. The ANDA (Abbreviated New Drug Application) process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
1. contain the same active ingredients as the innovator drug (inactive ingredients may vary)
2. be identical in strength, dosage form, and route of administration
3. have the same use indications
4. be bioequivalent
5. meet the same batch requirements for identity, strength, purity, and quality
6. be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
In short, the generic versions of Rogaine for Men Extra Strength available over the counter in the U.S. are essentially identical to the name brand and would be expected to be equally effective for you in the treatment of MPB.
Happy Valentine's Day!
Richard Lee, M.D.
Regrowth, LLC
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