Archive for the ‘Patent Expiration 2014’ Category

Eptifibatide Continues to be Successful as an Antiplatelet Agent

Monday, August 6th, 2012

Eptifibatide, CAS# 188627-80-7, is an antiplatelet agent. Also offered from LGM Pharma as a TEVA API (TAPI) product for compounding purposes, eptifibatide is also known by the brand name Integrilin, which is marketed by Merck. With Merck’s patent for Integrilin due to expire on November 11, 2014, and an additional patent revision due to expire on May 5, 2015, this powerful drug is set to be a generic blockbuster.

Eptifibatide angioplastyEptifibatide is effective as it keeps the platelets in your blood from clotting or coagulating, which prevents unwanted blood clots from forming. This is especially important for treating patients with certain heart or blood vessel conditions. In addition, patients who are undergoing an angioplasty, or a procedure to open blocked arteries, are often dosed with eptifibatide to prevent blood clots from forming after surgery. As an injectable medication, eptifibatide is administered through an I.V. in a hospital or ambulatory care setting. Often times the injection is dispensed around the clock for up to four days in a row. Eptifibatide may also be given throughout an angioplasty procedure, and up to 24 hours following. Aspirin may sometimes be dispensed as an adjunct therapy to eptifibatide, under a physician’s supervision only. Because eptifibatide keeps your blood from clotting, it can also make it easier for patients to bleed, even from a minor cut. It is imperative that any patient who receives eptifibatide and experiences uncontrolled bleeding to stop taking this drug and seek medical assistance. Side effects of eptifibatide may include nausea, stomach upset and bleeding around the I.V. injection point. The initial dose for patients with angina pectoris, acute coronary syndrome, myocardial infarction or percutaneous coronary intervention is 180 mcg/kg, to be administered intravenously as soon as possible following the diagnosis.

eptifibatideResearch teams are prepared for a study to be halted due to safety and tolerability issues, but they are typically not prepared for a study to cease due to success. This was the case for the ESPRIT study, which involved 2,400 patients undergoing coronary intervention and dosed with eptifibatide (Integrilin). An interim analysis of 1,758 patients showed a significant reduction for the combined incidence of death or myocardial infarction with patients who received eptifibatide versus those who received a placebo. This reduction was substantial, accounting for over 50 percent of patients at a 30 day interim analysis, thus halting the need for further investigation. In addition to this outstanding discovery, many patients displayed positive results from their injection of eptifibatide after only 48 hours. The reliability and efficacy of eptifibatide has been demonstrated, paving the way for generic options of this phenomenal drug. LGM Pharma is a provider of the API and TEVA API of eptifibatide for research and development, and offers complete support to clients throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Exercise is Possible for Patients Suffering from PAH with Ambrisentan

Wednesday, August 1st, 2012

AmbrisentanPatients suffering from debilitating pulmonary arterial hypertension, or PAH, find extensive relief when treated with ambrisentan. Also known as the brand name Letairis, marketed by Gilead, ambrisentan is effectual at preventing the thickening of the blood vessels, particularly those in the heart and lungs. Ambrisentan, CAS number 177036-94-1,  treats the high blood pressure in the arteries of the patient’s lungs, lowers their blood pressure and helps the heart to pump better and more efficiently.

Ambrisentan is available in oral tablets, both 5 and 10 milligrams. Typically taken orally with or without food, the initial dose for the majority of patients is 5 milligrams once a day. The dose may be increased if needed on a case by case basis to 10 milligrams once a day. Side effects may include vomiting, headache, constipation, stomach pain, sinus pain and sore throat. Due to the risk of serious birth defects, Letairis is currently only offered to patients through a program called LEAP, or Letairis Education and Access Program, in the United States. This is not the standard worldwide. As Letairis approaches the end of it’s patent December 30, 2014, researchers are seeking to develop generic formulations of this unique product to provide greater options for patients.

One of the distinct benefits of ambrisentan is how effective it is at improving the ability of patients to exercise, and also preventing the PAH condition from getting worse. The patient population suffering from untreated pulmonary arterial hypertension experiences symptoms such as shortness of breath, especially when exercising, exhaustion, fainting, dizziness and swelling of the extremities, specifically the legs and arms. Ambrisentan aids patients by blocking the effects of a substance called endothelin, a small peptide hormone which is made by the body in greater then normal amounts in patients with PAH. This excess endothelin causes the blood vessels to constrict and leads to an overgrowth of the muscle in the walls of the blood vessels in the lungs. Efficacious at blocking the action of endothelin, ambrisentan is a boost for the health and activity of people in this patient group. There have been gratuitous amounts of studies completed regarding ambrisentan, primarily sponsored by Gilead, which indicated significant benefits to patients who received the drug. These aforementioned studies were mainly short term, and randomized, however there were also several long term open label trials as well. Data recorded from both short and long term trials demonstrated clearly that ambrisentan improves exercise capacity and delays clinical worsening in PAH patients. Other benefits to the administration of ambrisentan include a low incidence of liver toxicity, a lowered incidence of interactions with other drugs, including anticoagulants, and a potent bioavailability which allows even low doses for a therapeutic effect. LGM Pharma is a provider of the API ambrisentan for research and development purposes.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Patients With Stents Benefit From Clopidogrel

Tuesday, July 24th, 2012

The FDA exclusivity for Plavix (clopidogrel) ended on May 17, 2012, while patent protection expires January 31, 2014. This exciting news brings Clopidogrel CAS# 113665-84-2, to the forefront of pharmaceutical news. With sales of Plavix generating billions of dollars for Bristol-Myers Squibb/Sanofi Pharmaceuticals, researchers are clamoring to create generic options of clopidogrel. As an antiplatelet drug that works by keeping the platelets in your blood from clotting, clopidogrel if effectual in preventing heart attacks and strokes in predisposed patients. Offered in doses of both 75 and 300 milligrams, clopidogrel is typically dosed as one 75 milligram tablet per day, with or without food. For adults with Atrial Fibrillation or those adults who cannot take oral anticoagulants, such as warfarin, they may also be prescribed 75 milligrams once daily. In patients with unstable angina, or those who have recently had a heart attack, they may be prescribed a one time dose of 300 milligrams, followed by a 75 milligrams once daily treatment.

Clopidogrel Stent
On June 5th, 2012 findings were reported from the Veterans Administration Drug-Eluting Stent Study. The publication,  Circulation: Cardiovascular Interventions revealed positive results from this study, indicating an effectual outcome for patients who received clopidogrel after bare-metal and drug-eluting stent placements. This study involved 29,175 veterans, and took place between 2002 and 2006. The risks for those patients who received prolonged clopidogrel, for greater then one year, was associated with a lower adjusted risk of death for both drug-eluting and bare metal stents. The greatest effects were for the patients who were treated with drug-eluting stents and who received prolonged clopidogrel, as they had a significantly lower rate of either death or myocardial infarction. According to William Fay, director of the division of cardiovascular medicine for the University of Missouri and americanheart.org, more than 500,000 heart stents are placed each year in the U.S.  This estimate is only expected to grow with the elderly population growing and the advancement of medical care and technology. Clopidogrel has been a gold standard medication for stent patients and will continue to be.

Patients who take Plavix should inform their doctor if they have any bleeding disorders, such as bleeding ulcers or hemophilia. Side effects may include exhaustion, dizziness, headache, nausea, stomach pain, diarrhea, itching and an increased risk of nosebleeds.

Clopidogrel Bisulfate is also available from LGM Pharma, as well as the Clopidogrel Bisulfate TEVA API (TAPI) for compounding purposes.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

 

 

Shocking Diagnosis of Reality Star Creates a Whirlwind of Attention for Glatiramer Acetate

Friday, June 22nd, 2012

Jack OsbourneGlatiramer, CAS# 28704-27-0, and Glatiramer Acetate, CAS# 147245-92-9, are also known as Copaxone. In the spotlight recently, Copaxone’s patent is due to expire on May 24, 2014. The flurry of interest regarding Copaxone follows the devastating diagnosis of Multiple Sclerosis for beloved reality star Jack Osbourne. In mid June of 2012 reports surfaced about Jack’s new battle, which he was saddled with just three weeks after the birth of his daughter. Symptoms like a 60 percent sight loss in one eye and tingling in his extremities led this young man to seek medical attention. Typical symptoms of MS include inflammation in the brain and spinal cord, causing the loss of myelin or insulation around the nerves, as well as weakness, fatigue, vision loss, and numbness. The progression of MS is unknown and can vary with each patient, causing acute symptoms to be mild, moderate or severe. However, in the midst of the disturbing news there is hope. Glatiramer, or Copaxone, marketed by Teva, is a definite treatment option for Mr. Osbourne, according to reports at NBC.com. In addition to treatment with not only glatiramer acetate, patients like Jack have a variety of symptom easing medications, such as dexamethasone and prednisone for swelling and inflammation, and trazadone for depression and tremors.

Glatiramer Acetate is an immunomodulating drug, and is essentially an artificial protein that resembles a natural myelin protein. It is believed to be effectual by preventing the body’s immune system from attacking the myelin coating that protects nerve fibers in patients with MS. Given as an injection, subcutaneously once a day, glatiramer was formerly known as copolymer-1. Offered in a 20 milligram size, glatiramer may cause adverse effects such as diarrhea, headache, depression, nausea, vomiting, ear pain, joint pain and purple patches on the skin.

Glatiramer AcetateOn June 14, 2012 Teva reported that goals from a late stage clinical trial recently were revealed, and pointed to a favorable outcome for patients taking Copaxone. Patients who took the newer version of glatiramer acetate were reported to be 34 percent less likely to have a symptom relapse. This study lasted a year, and compared patients who took a placebo, versus patients given glatiramer. With the patent for Copaxone set to expire in less then a year, this information is uplifting and reassuring to researchers, prescribers and patients. LGM Pharma is a provider of the API glatiramer acetate and glatiramer, and offers complete support to clients throughout the R&D process. As the Sole Distributor of Teva for their extensive API portfolio, for the US pharmacy compounding market, LGM Pharma looks forward to providing clients with TEVA products, as well as other quality API products.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

A Trio of Uses for Mometasone Furoate

Monday, June 18th, 2012

asthmaMometasone Furoate, CAS# 83919-23-7 is in the class of drugs known as corticosteroids, there are several products in which mometasone furoate is efficacious. For the treatment of asthma, mometasone furoate may also be known by the brand name Asmanex Twisthaler. Offered in powder form, inhalation 110 mcg/actuation or 220 mcg/actuation, mometasone furoate relieves asthmatic symptoms by decreasing swelling and irritation in the airways of patients. In addition, it may be useful in preventing breathing difficulties and chest tightness, as well as wheezing, and coughing caused by asthma. While mometasone furoate should not be used to treat an acute asthma attack, it is a formidable solution for controlling asthma in affected patients. Mometasone works best if it is inhaled at the same time daily, either once or twice a day as prescribed. Side effects may include heartburn, headache, stomach pain, vomiting, dry throat and nosebleeds. The patent for the use of mometasone furoate for the treatment of lower airway passage and lung diseases is expiring January 27, 2014, paving way for generic equivalents for treating the ever growing population of patients with asthma. asthma-diagnosis-chartAccording to The American Academy of Allergy, Asthma & Immunology, the number of people with asthma in the United States is steadily growing. For example, in 2001, 1 in 14 Americans had been diagnosed with asthma, or about 7% of the population. As of 2009 1 in 12 people, or 8% of the U.S. population has an asthma diagnosis. Additionally an estimated 300 million people worldwide are currently projected to suffer from asthma, causing 250,000 annual deaths. Treatment with inhaled corticosteroids, such as the popular asthma drug Dulera (formoterol/mometasone) has certainly offered viable solutions for this large patient population.

asthma-triggersAllergic rhinits and seasonal allergies are vastly problematic, and mometasone furoate meets the need for treatment in the form of an intranasal spray. Known by the brand name Nasonex and available in a 50 mcg size, mometasone furoate is effectual when used by patients once daily, either one or two sprays in each nostril. Side effects may include sore throat, cough, vomiting and headache. As a nasal inhalation treatment mometasone is often a preferable option for patients who don’t want to experience side effects of typical oral allergy medications. With allergic diseases affecting 40 to 50 million Americans, according to The American Academy of Allergy, Asthma & Immunology, continued research using mometasone furoate is essential.

Mometasone FuroateKnown as brand names Elocon and Momexin, mometasone furoate is also available in topical cream, ointment and lotion formations. Typically prescribed to patients suffering from eczema, atopic dermatitis, psoriasis, contact dermatitis, seborrhea and poison ivy, mometasone furoate is quite versatile. Adverse effects are few, but may include skin irritation, dryness and itching.

Effective for treating conditions such as asthma, allergic rhinitis, and inflammatory skin conditions, mometasone furoate is offered for research and development in several forms. LGM Pharma is a provider of mometasone furoate, and offers complete support to clients throughout the R&D process. Inquire about US-DMF , E-DMF / CTD, CEP (CoS) for this API product. This API is also available as a TEVA API (TAPI) for compounding purposes in the US.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.