ANDA Litigation Settlements

Fall 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name

Drug

Patent
No(s).

Publicly Available Terms

Somaxon Pharma. Inc. v. Par Pharma. Inc., 11-0476 (D. Del.)

Somaxon Pharma. Inc. v. Mylan Inc., 11-0571 (D. Del.)

Silenor®(doxepin tablets)

7,915,307

6,211,229

Mylan will get exclusive right to start selling an authorized generic of Silenor in the U.S. on Jan. 1, 2020;

Mylan’s exclusivity is good for 180 days but may extended for up to 360 days;

Somaxon and Mylan also entered into a supply agreement;

In a separate agreement with Somaxon, Par will be able to start selling a generic version of Silenor 180 days after another generic version of Silenor is sold in the U.S. by a third party.

AstraZeneca Pharma LP v. Intellipharmaceutic Corp., 11-4498, 12-2855 (S.D.N.Y.)

Seroquel XR®(quetiapine fumerate extended-release tablets)

4,879,288

5,948,437

IPC shall not market its generic product until November 2016;

Patents-in-suit are valid and enforceable.

Pfizer Inc. v. Impax Labs., Inc., 08-2137 (D.N.J.)

Detrol®LA (tolterodine tartrate extended-release capsules)

5,382,600

6,630,162

6,770,295

N/A

Alza Corp. v. Impax Labs., Inc., 11-0395 (D. Del.)

Concerta®(methylphenidate hydrochloride extended-release tablets)

6,930,129

Impax may sell generic Concerta effective July 2014;

Impax’s settlement authorizes Teva to market Impax’s generic tablets.

Shire LLC v. Anchen Pharma., Inc., 10-0484 (D. Del.)

Intuniv®(guanfacine hydrochloride extended-release tablets)

6,287,599

6,811,794

5,854,290

Shire will receive royalties when TWI makes—and Anchen sells—generic Intuniv tablets effective July 1, 2016;

Anchen is TWI’s authorized distributor, but is also authorized to occasionally sell generic Intuniv tablets and pay Shire royalties.

Genzyme Corp. v. Impax Labs., Inc., 09-0653 (D. Md.)

Genzyme Corp. v. Impax Labs., Inc., 09-0846 (D. Md.)

Renagel®(doxepin tablets)

 

Renvela® (doxepin tablets)

5,667,775

Impax may sell certain dosages of generic Renagel tablets and generic Renvela liquid treatments effective Sept. 16, 2014;

Impax may sell other dosages of generic Renagel tablets effective Mar. 16, 2014.


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