against the resale of hydrochlorothiazide in straight formulation.
14. "Approved-combination-only restriction" means a restriction on or limitation against the resale of hydrochlorothiazide other than as a combination product that has been previously approved (in this case, by CIBA).
15. "Edema" means the condition of an excess of water in the body which occurs when the body does not eliminate a sufficient quantity through the kidneys, thereby resulting in a back pressure through the veins pushing water and fluid through the capillaries out into the tissues causing such conditions as congestive heart failure, chronic lung disease, chronic cirrhosis and kidney failure.
16. "Diuresis" is the washing of salt and water out of the body by urinary excretion.
17. "Diuretic" means a chemical substance which produces diuresis.
18. "Hypertension" means an elevation of the blood pressure within the arterial system of the body which is in excess of the generally accepted level of 140 cystolic or pumping pressure and 90 diastolic or resting pressure. There are different degrees of hypertension generally referred to as mild, moderate, moderate to severe, and severe, depending upon the extent of the elevation of the blood pressure. It is generally believed in the medical profession that, as has been demonstrated by short-term and long-term studies, such elevation of the blood pressure is directly contributory to the early onset of strokes, heart attacks, kidney failure, etc.
19. "Antihypertensive" means a chemical substance which reduces blood pressure and is used for the treatment of hypertension.
20. "Saluretic" means a pharmaceutical product which causes increased excretion of salt in the urine.
21. "Benzothiadiazine" means any derivative of a 3,4-dihydros-2-H-(1,2,4)-benzothiadiazinesp-1,1-dioxide.
22. "Cyclothiazide" means, and is the generic name for, the benzothiadiazine with the chemical name 6-chloro-3,4-dihydro-3-(5-nor-borensp-2-yl)-7-sulfamoyl-1,2,4,- benzothiadiazine-1,1-dioxide.
23. "Hydrochlorothiazide" (hereinafter referred to as HCT) is the generic name for one benzothiadiazine derivative covered by United States Letters Patent 3,163,645, which issued to CIBA on December 29, 1964 and which will expire on December 29, 1981.
24. "Chlorothiazide" means, and is the generic name for, the benzothiadiazine with the chemical name 6-chloro-2-H-1,2,4,-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Benzothiadiazines are one group of drugs which are used as diuretics, saluretics, and antihypertensives. In such therapy they are administered orally either alone or in conjunction with other drugs. The therapeutic effectiveness of the benzothiadiazines can be increased by administering them together with one or more other drugs. One widely used benzothiadiazine is HCT.
A commonly employed drug treatment for hypertension is the use of HCT plus reserpine, an antihypertensive and calming agent. The ratio of the HCT to the reserpine that produces the maximum therapeutic effect varies from patient to patient. The various combination products of this type, however, are marketed in the form of a fixed ratio of the two therapeutically active ingredients.
Hypertension is also treated by the use of combinations of HCT and other drugs, such as deserpidine, syrosingopine, butabarbital, meprobamate, methyldopa, guanethedine sulfate, and hydralazine-hydrochloride. As in the case of reserpine, for any given patient there exists an optimum ratio of the benzothiadiazine to the other therapeutically active product or products. Nevertheless, the various combination products containing HCT and one or more of these therapeutically active ingredients are marketed in a form which contains a fixed ratio of the ingredients.
Another benzothiadiazine which is used as a diuretic and antihypertensive agent is cyclothiazide. Cyclothiazide is marketed by Lilly in dosage form, in straight formulation and in combination with reserpine and other products for use as a diuretic and antihypertensive agent.
COMMERCE RELATING TO HYDROCHLOROTHIAZIDE
At least until the filing of this complaint in 1969, HCT was sold in the United States in dosage form, as such, by only three companies: by CIBA as "Esidrix," by Abbott as "Oretic," and by Merck as "Hydro-DIURIL."
In 1969, CIBA, Merck and Abbott accounted for over $ 22 million in sales of HCT in dosage form, as such.
HCT has also been sold in dosage form in combination with other drugs by the companies and under the trade names listed below:
COMPANY TRADE NAME OTHER DRUGS
Abbott Oreticyl deserpidine
Carter Caplaril mebutamate
CIBA Apresoline-Esidrix hydralazine-HC1
Esidrix-K potassium chloride
Esimil guanethedine sulfate
Ser-Ap-Es reserpine and
McNeil Butiserpazide reserpine and
Merck Aldoril methyldopa
Searle Aldactazide spironolactone
Smith, Kline & French Dyazide triamterene
Warner Perithiazide pentaerythritol
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