Regulatory/IP update

*Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths.

*Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet

*Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules, 100 mg

*Watson Receives Final Approval of Omeprazole Delayed-Release Capsules 10mg, 20mg and 40mg

*U.S. Patent & Trademark Office (PTO) has completed the second of four reexamination proceedings and has confirmed the patentability of US5922695 which covers the composition of matter for Viread (Tenofovir Disoproxil Fumarate).

*Barr has filed Paragraph IV on Entocort Enteric Coated Capsules (Budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort

Fentanyl buccal tablet: Cephalon Files Patent Infringement Lawsuit Against Watson

Cephalon today announced that it has filed a lawsuit in U.S. District Court of Delaware against Watson for infringement of US6200604 (Expiry: Mar 26, 2019) and US6974590 (Expiry: Mar 26, 2019), which cover methods of use for the O.B listed product Fentora (Fentanyl buccal tablet).
Fentanyl (N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenyl-propanamide) was approved by the USFDA in September 2006 for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. One advantage of such tablets is claimed to be quicker absorption into the bloodstream at lower dosage levels.Fentanyl is not considered a first line opioid in palliative care.