Information about Indian Patent Laws for Drugs and Cipla Company Information.

Generic Prozac is made in India. Even though it contains the exact same chemical as Prozac (Fluoxetine 20 mg), its cost is significantly less than that of Prozac.

Cipla is allowed by Indian patent law to make drugs that are patented by other companies internationally as the law protects only the processes by which drugs are made, and not the drugs themselves.

Under current Indian law, which recognizes patents on ways to make drugs but not the drugs themselves.

This means Indian companies can make drugs under patent in the West, provided they use a process that is different from the original.

Manufacturers are able to produce and sell medicines here at a tiny fraction of the prices charged in the United States. In some cases, though, the generic makers have been blocked from selling their wares in other developing countries that have Western-style patent laws.

Composition

Each capsule contains Fluoxetine Hydrochloride equivalent to Fluoxetine 20 mg.

Indications

Generic Prozac is indicated for the treatment of symptoms of major depression and obsessive compulsive disorders.

Dosage and Administration

Major Depression

Generic Prozac may be used for initiation of anti-depressant therapy. Generic Prozac may be used for titrating the dose and also in patients in whom a low-dose maintenance therapy is required. The maintenance dosage is 20 mg daily administered in the morning. Although symptomatic relief may be apparent within the first 1-3 weeks of Generic Prozac therapy, optimum anti-depressant effect usually requires at least 4 weeks or more of therapy with the drug. A dose increase may be considered after several weeks if no clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or on a b.i.d. schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day.

Obsessive-Compulsive Disorder

A dose of 20 mg/day administered in the morning is recommended as the initial dose. A dose increase may be considered after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.

Doses above 20 mg/day may be administered on a once-a-day (morning) schedule or on a b.i.d. schedule (i.e. morning and noon) not exceeding 80 mg/day.

Contra-Indications

Hypersensitivity to the drug.