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5 Aug 2011, 12:29 pm by Josh Myers
 Manufacturers who have filed the appeal are: Actavis, Inc., Mylan, Inc., Teva Pharmaceutical Industries, and UDL Laboratories, Inc. [read post]
3 Aug 2011, 3:31 am by Marie Louise
Paddock (Orange Book Blog) (Holman’s Biotech IP Blog) Cetrorelix – UK: Non-payment of Cetrorelix fee on time fatal for SPC: Case BLO/252/11 The Administrators of the Tulane Education Fund (The SPC Blog) Detrol (Tolterodine tartrate) – US: Pfizer files patent infringement complaint against Torrent Pharma in response to Para IV certification filing (Patent Docs) Galantamine – EU: CJEU ruling in Case C-427/09 Generics (UK) Ltd v Synaptech (The SPC Blog) (EPLAW) Memantine –… [read post]
1 Aug 2011, 8:19 am
Actavis Elizabeth LLC et al, Case No. 2010-1500 in the Court of Appeals for the Federal Circuit, decided July 29, 2011. [read post]
27 Jul 2011, 1:01 am by Marie Louise
(IPBiz) (Patently-O) (Patent Docs) (GenericsWeb) Copaxone (Glatiramer) – US: Mylan and Momenta challenge Teva patent on Copaxone (IPBiz) Gemzar (Gemcitabine) – US: Strides Arcolab announces US FDA approval for Gemcitabine for injections USP (GenericsWeb) Glybera (Alipogene tiparvovec) – EU: EMA continues to defer approval of first gene therapy application in Europe (Patent Docs) Jalyn (Dutasteride, Tamsulosin) – US: Watson files ANDA to market generic Jalyn, Glaxo responds… [read post]
13 Jul 2011, 3:04 am by Marie Louise
Doubtful (FDA Law Blog) US: Joint citizen petition asks FDA for clarity on off-label use manufacturer-communications (FDA Law Blog)   Products Allegra (Fexofenadine) – US: Sanofi settles with Actavis in Allegra suit (Patent Docs) Aloxi (Palonosetron) – US: Roche sues Teva, Sandoz, Dr Reddy over generic Aloxi (GenericsWeb) Amrix (Cyclobenzaprine) – US: CAFC changes course, denies stay of injunction of Mylan’s generic Amrix sales: In re Cyclobenzaprine… [read post]
23 Jun 2011, 1:00 pm by Nathan Koppel
The defendants included Actavis Inc. and other drug makers. [read post]
15 Jun 2011, 4:56 am by Marie Louise
Actavis (Kluwer Patent Blog) Viagra (Sildenafil) – US: Patent infringement complaint filed in response to Para IV certification: Pfizer Inc. et al. v. [read post]
31 May 2011, 8:38 pm by Marie Louise
Novo Nordisk (Orange Book Blog) Silenor (Doxepin) – US: Somaxon files patent infringement lawsuit against Par Pharmaceuticals over bid to market generic Silenor (GenericsWeb) Strattera (Atomoxetine) – US: Eli Lilly files patent infringement complaint against Zydus in response to Para IV certification (Patent Docs) Zemplar (Paricalcitol) – US: Abbott Lab’s files patent infringement complaint against Sandoz in response to Para IV certification (Patent Docs) Ziana (Clindamycin,… [read post]
18 May 2011, 12:33 am by Marie Louise
Du Pont (EPLAW) Opana (Oxymorphone) – US: CAFC: important decision controlling BPAI obviousness holdings: In re Kao (Patently-O) (PharmaPatents) Silenor (Doxepin) – US: Somaxon sues Actavis over application to market generic Silenor (GenericsWeb) Tanakan (Ginko Biloba) – France: Mylan ordered to pay €17M to Ipsen for unfair competition by marketing Vitalogink to pharmacists as an “equivalent” to Tanakan (EPLAW) Valcyte (Valganciclovir) – US:… [read post]
4 May 2011, 7:52 am by Tron Emptage
Brand Name Opioid Products Generic Name Trade Name Applicant/Sponsors Fentanyl Duragesic Extended Release Transdermal System Ortho McNeil Janssen Hydromorphone *Palladone Extended Release Capsules Purdue Pharma   Methadone Dolophine Tablets Roxanne Morphine Avinza® Extended Release Capsules King Pharms   Morphine Kadian® Extended Release Capsules Actavis   Morphine MS Contin Extended Release Tablets Purdue Pharma… [read post]
4 May 2011, 4:13 am by Marie Louise
(Docket Report) Provigil (Modafinil) – EU announces anti-trust probe into a Cephalon – Teva deal concerning generic Provigil (The IP Factor) (GenericsWeb) Valsartan – Norway: District Court of Oslo forbids Actavis to market any products containing Valsartan produced by using the process QSSA Route C until 13 May 2011 (EPLAW) Welchol (Colesevelam) – US: Daiichi Sankyo, Genzyme file patent infringement complaint against Watson in response to Para IV certification… [read post]
21 Apr 2011, 11:14 pm
Generic manufacturers like Pliva Inc. and Actavis Inc. who make generic Reglan (including the pills that DeMahy used) may end up being responsible for not updating their warning labels to include information that the brand name manufacturers include in theirs even though federal laws didn’t let them include the warnings. [read post]
18 Apr 2011, 5:08 am by Ronald V. Miller, Jr.
Fentanyl patches: Generic drugmaker Actavis issued a recall for 200,000 units of its Fentanyl Transdermal System 25mcg/h (called Fentanyl patches) because they exceeded dissolution specifications in stability testing. [read post]
6 Apr 2011, 12:18 am by Marie Louise
Laboratorios Rubió (EPLAW) Gemzar (Gemcitabine) – US: ITC: Target date of 23 July 2012 set in Certain Gemcitabine (ITC 337 Law Blog)  Intuniv (Guanfacine) – US: Shire files patent infringement complaint based on Mylan’s ANDA filing (Patent Docs) Isentress (Raltegravir) – India: Cipla files for compulsory license against Merck’s Isentress (Spicy IP) Losartan, HCTZ – France: Cour d’appel confirms combination products infringe mono-SPCs and sets… [read post]
29 Mar 2011, 9:19 pm by Marie Louise
Navinta (Patently-O) NuvaRing (Etonogestrel, Ethinyl estradiol) – US: ITC institutes investigation (337-TA-768) regarding Certain Vaginal Ring Birth Control Devices (ITC 337 Law Blog) Nuvigil (Armodafinil) – US: Cephalon drops patent suit against Actavis over Nuvigil generic (Patent Docs) Oxycontin (Oxycodone) – US: Purdue Pharma files patent infringement suit against Watson in response to Para IV certification filing (Patent Docs) Perindopril – UK: EWHC (Pat):… [read post]