Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approvala

8/28/01

Topiramated

Topamax

As adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome

11/20/01

Bosentan

Tracleer

Treatment of pulmonary arterial hypertension

1/18/02

Nitisinone

Orfadin

Adjunctive therapy to dietary restriction of tyrosine and phenylalanine in treatment of hereditary tyrosinemia type 1

7/17/02

Oxybate

Xyrem

Treatment of cataplexy associated with narcolepsy

10/8/02

Buprenorphine in combination with naloxone

Suboxone

Treatment of opioid dependence in patients 16 years of age or older

10/8/02

Buprenorphine hydrochlorided

Subutex

Treatment of opioid dependence in patients 16 years of age or older

11/22/02

Nitazoxanide

Alinia

Treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia

3/25/03

Pegvisomantc

Somavert

Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate

7/31/03

Miglustatd

Zavesca

Treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option

12/1/03

Somatropin (r-DNA)c,e

Zorbtive

Treatment of short bowel syndrome in patients receiving specialized nutritional support

3/8/04

Cinacalcetd

Sensipar

Treatment of hypercalcemia in patients with parathyroid carcinoma

4/20/04

Apomorphine HClc

Apokyn

For the acute, intermittent treatment of hypomobility, “off” episodes, associated with advanced Parkinson’s disease

5/17/04

Tinidazole

Tindamax

(1) Treatment of giardiasis caused by G. duodenalis (also termed G. lamblia). (2) Treatment of intestinal amebiasis and amebic liver abcess caused by E. histolytica.



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