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ANDA Litigation Settlements

Case Name Drug Patent No(s). Publicly Available Terms

Galderma Labs. LP v. Actavis Mid Atlantic LLC, 12-2038 (N.D. Tex.)

Epiduo® (Adapalene / benzoyl peroxide)

7,820,186
7,964,202
8,071,644
8,080,537
8,105,618
8,129,362
8,241,649

N/A

Takeda Pharm. Co. v. TWi Pharms. Inc., Fed. Cir. No. 14-1074 (Fed. Cir.)

Dexilant® (dexlansoprazole)

7,737,282
7,790,755

TWi may launch its generic product 180 days after the first applicant to file an ANDA markets its product. Parties entered into a license and supply agreement that allows TWi and its affiliates to sell Dexilant in its 30 mg and 60 mg dosage strengths as an authorized generic.

Janssen Products, L.P. v. Cipla Ltd., 15-0307 (D. Del.)

Prezista® (darunavir tablets)

7,700,645
8,518,987
7,126,015
7,595,408

Cipla admits that each of the asserted claims are valid and enforceable. Cipla is enjoined from manufacturing, using, offering for sale, selling in the U.S., or importing into the U.S. Cipla’s generic product until a “start date” under the parties’ license agreement.

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