EMEDASTINE DIFUMARATE, EMADINE, 8 TH DEC 2013 PATENT EXPIRY

New Drug Approvals

EMEDASTINE DIFUMARATE

Emedastine difumarate (Emadine) is a second generation antihistamine used in eye drops to treat allergic conjunctivitis. Its mechanism of action is a H1 receptor antagonist.

EMADINE

Drug Patent Expiration and Exclusivity

Active Ingredient Form Dosage Drug Type Application Product
EMEDASTINE DIFUMARATE SOLUTION/DROPS; OPHTHALMIC 0.05% RX 020706 001

Patents

There are 1 patent(s) protecting ALCON’s EMADINE.
The last patent expires on 2013-12-08.

Patent Expiration
US5441958 Ophthalmic compositions comprising emedastine and methods for their use
Topical ophthalmic compositions comprising 1-(2-ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)-benzimidazole and its ophthalmically acceptable acid addition salts have been found to be useful in treating allergic conjunctivitis and related ailments.
2013-12-8

Exclusivity

Exclusivity is marketing rights granted by the FDA to the ALCON.

EMADINE ® (emedastine difumarate ophthalmic solution) 0.05% is a sterile ophthalmic solution containing emedastine, a relatively selective, H1-receptorantagonist for topical administration to the eyes. Emedastine difumarate is a white, crystalline, water-soluble…

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Veterinary-Dirlotapide, drug used to treat obesity in dogs

New Drug Approvals

1-Methyl-N-[(1S)-2-(methyl-(phenylmethyl)amino)-2-oxo-1-phenylethyl]-5-[​[oxo-[2-[4-(trifluoromethyl)phenyl]phenyl]methyl]amino]-2-indolecarboxamide

Chemical Formula

C40-H33-F3-N4-O3

Molecular Weight

674

Therapeutic Category, dog

Antiobesity agent

Chemical Names

N-{(1S)-2-[Benzyl(methyl)amino]-2-oxo-1-phenylethyl}-1-methyl-5-[4′-(trifluoromethyl)biphenyl-2-carboxamido]-1H-indol-2-carboxamide (WHO)

1H-Indole-2-carboxamide, 1-methyl-N-[(1S)-2-[methyl(phenylmethyl)amino]-2-oxo-1-phenylethyl]-5-[[[4′-(trifluoromethyl)[1,1′-biphenyl]-2-yl]carbonyl]amino]- (USAN)

1-Methyl-5-[(4′-trifluormethylbiphenyl-2-carbonyl)amino]-1H-indol-2-carbonsäure-[(S)-(benzylmethylcarbamoyl)phenylmethyl]amid (IUPAC)

5-[4′-(Trifluoromethylbiphenyl-2-carbonyl)amino]-1H-indole-2-carboxylic acid benzylmethyl carbamoylamide

Identifiers
CAS number 481658-94-0 
ATCvet code QA08AB91

Dirlotapide is a drug used to treat obesity in dogs. It is manufactured by Pfizer and marketed as Slentrol.

It works as a selective microsomal triglyceride transfer protein (MTTP) inhibitor. This blocks the assembly and release of lipoproteins into the bloodstream, thereby reducing fat absorption. It also elicits a satiety signal from lipid-filled cells lining the intestine.

It is supplied as an oral solution. It is not intended for use in humans, cats, or parrots.

On January 5 2007, the U.S. Food and Drug Administration (FDA) approved Slentrol, the first time the FDA has approved a drug for obese dogs.[1]

Dirlotapide is used to manage obesity in dogs and helps…

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Epratuzumab

New Drug Approvals

Epratuzumab

Epratuzumab is a humanised anti-CD22 monoclonal antibody under investigation (clinical development phase III) for its efficacy in SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function.

Expected indication Systemic lupus erythematosus
R&D stage Phase 3 ongoing (started in December 2010)
Next milestone Phase 3 results (H1 2014)
Quick facts

Epratuzumab is a humanized monoclonal antibody. Potential uses may be found inoncology and in treatment of inflammatory autoimmune disorders, such as lupus (SLE).[1][2] The manufacturers in August 2009 announced success in early trials against SLE.[3]

Epratuzumab binds to the glycoprotein CD22 of mature and malignant B-cells.

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GSK and Genmab seek alternative approval for leukaemia drug Arzerra

New Drug Approvals

Arzerra

GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.

The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

READ ALL AT

http://www.pharmaceutical-technology.com/news/newsgsk-and-genmab-seek-alternative-approval-leukaemia-drug-arzerra?WT.mc_id=DN_News

Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a humanmonoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia…

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OCRELIZUMAB

New Drug Approvals

Ocrelizumab is a humanized anti-CD20 monoclonal antibody. It targets mature B lymphocytes[1] and hence is an immunosuppressive drug candidate. It is under development by Hoffmann–La Roche‘s subsidiary Genentech, and Biogen Idec.

It had reached Phase III clinical trials for rheumatoid arthritis[2] and lupus erythematosus,[3]and Phase II for multiple sclerosis[4] and hematological cancer.[5]

In March 2010, Roche announced the suspension of clinical trials in rheumatoid arthritis and lupus erythematosus. This step followed excess deaths due to opportunistic infections. Development for multiple sclerosis continues.[6]

In October 2010 Roche announced 24 week results from the PhII study in relapse remittingMS. The drug demonstrated a statistically significant reduction in disease activity as measured by brain lesions (measured by MRI scans) and relapse rate compared to placebo. Both doses (200 mg & 600 mg) were well tolerated.Anti-B cell…

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Current Oncology Pipeline Trends

New Drug Approvals

Oncology drug development far outpaces drug development for other therapeutic areas and the magnitude of that difference is significant. Here’s a current review of what is in the pipeline and an analysis of where oncology research is headed.

http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2013/may_june-2013/Current-Oncology-Pipeline-Trends

Stacey Ness, PharmD, RPh, MSCS, AAHIVP, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence, and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, National Association of Specialty Pharmacy, Specialty Pharmacy Certification Board, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a multiple sclerosis certified specialist, a credentialed HIV pharmacist, and currently serves as the director of specialty clinical services at Managed Health Care Associates, Inc, a health care…

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