Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approvala

6/10/04

Glutamine

Nutrestore

Treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication

8/12/05

Quinine sulfate

Qualaquin

Treatment of uncomplicated Plasmodium falciparum malaria

10/28/05

Nelarabinec,d

Arranon

Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens

11/2/05

Deferasirox

Exjade

Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age or older

12/20/05

Sorafenib

Nexavar

Treatment of patients with advanced renal cell carcinoma

12/27/05

Lenalidomide

Revlimid

Treatment of patients with transfusion dependant anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities

3/1/06

Cetuximabc,d,e

Erbitux

For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

3/29/06

Tacrolimusb,c

Prograf

Prophylaxis of organ rejection in patients receiving allogenic heart transplants

4/28/06

Recombinant human acid alpha-glucosidasec,e

Myozyme

For use in patients with Pompe disease (GAA deficiency)

5/2/06

Decitabinec

Dacogen

For treatment of patients with myelodysplastic syndromes



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