Tuesday, October 16, 2012

Par Pharma to acquire 15 generic products from Watson and Actavis Group

As per the terms of the consent order with the FTC, Watson and Actavis had agreed to divest a number of marketed and pipeline products to Par Pharmaceutical Companies, Inc. and Sandoz. The proposed order requires Watson or Actavis to sell assets related to four of the 18 drugs to Sandoz, and the rest to Par,

The four drugs to be divested to Sandoz include
Watson and Actavis must also transfer to Sandoz the manufacturing technology for generic
(1)dextromethorphan hydrobromide and quinidine sulfate capsules;
(2) extended release bupropion hydrochloride tablets;
(3) extended release diltiazem hydrochloride capsules (generic Tiazac)
(4) lorazepam tablets
Watson and Actavis should also supply Sandoz with extended release diltiazem hydrochloride
capsules (generic Tiazac) and lorazepam tablets during the transition period.

In furtherance to this consent order, Par Pharmaceutical Companies Inc., has entered into agreements with Watson Pharmaceuticals Inc. (WPI) and Actavis Group1 to purchase for cash five generic products that are currently marketed in the U.S. by Watson or Actavis, eight Abbreviated New Drug Applications currently awaiting regulatory approval and a generic product in late-stage development.

The five currently marketed products include
1) morphine sulfate extended release capsules, the generic version of Kadian,
2) fentanyl transdermal system CII,- the generic equivalent of Duragesic,
3)  nifedipine extended release tablets, the generic version of Adalat CC,
4) diltiazem hydrochloride extended release capsules, the generic equivalent of Cardizem CD,
5) metoclopramide hydrochloride tablets, the generic version of Reglan.

Generic Products in the Pipeline to be Divested include
 1) the generic version of extended- release Adderall XR, which is used to treat ADHD;
 2) the generic version of extended release Tiazac capsules, which are used to treat hypertension and angina;
3) the generic version of Endo Health Solutions, Inc.’s extended-release Opana ER tablets, which are used to treat chronic pain;
4) an alternate generic version of Watson and Pfizer, Inc.’s extended-release glipizide diabetes medication that boosts insulin production to control blood sugar levels;
5) an alternate generic version of Dynacirc, which is used to treat high blood pressure;
6) an alternate generic version of Loxitine, which is used to treat the symptoms of schizophrenia;
7) the generic version of Janssen’s extended-release Concerta, which is used to treat ADHD in people over age six; and
8) alternate generic versions of Watson’s Urso 250 and Urso Forte, which are used to treat a certain type of cirrhosis.
Future Products in Development
Finally, the FTC’s complaint alleges that the proposed acquisition would reduce future competition in the markets for six generic drugs that are not currently on the market, but are in development by both Watson and Actavis.  They include:
1) a topical treatment for acne;
 2) a product to treat uncontrolled episodes of crying or laughing in people with certain neurological diseases:
3) a product used to treat acne pain;
4) a generic version of the tamper-resistant pain relief drug OxyContin;
5) an extended-release patch used to treat Alzheimer’s disease and dementia resulting from Parkinson’s disease; and
 6) a generic version of Pfizer’s Chantix, which is used to help people stop smoking.