ANDA Litigation Settlements

Fall 2012

GENERICally Speaking

Case Name



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)



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)



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)





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

Concerta®(methylphenidate hydrochloride extended-release tablets)


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)




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)


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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