A host of new generics launch in 2015

Amneal

Since June, Amneal has launched four new products:

• Temozolomide capsules (AB-rated to Temodar) in six different strengths;

• Divalproex sodium extended release (AB-rated to Depakote ER) in 250 mg and 500 mg tablets 

• Tobramycin inhalation solution (a generic equivalent for Tobi inhalation solution) 

• Memantine hydrochloride (generic for Namenda) tablets in 5-mg and 10-mg dosage strengths

See also: New products for pharmacists 07-10-2015  

Camber

Camber Pharmaceuticals announced several generic pharmaceutical launches this year, including generic versions of Famvir (famciclovir), Abilify (aripiprazole), Revatio (sildenafil), Maxalt (rizatriptan benzoate), and Protonix (pantoprazole).

In May, Camber provided suppliers with famciclovir tablets in doses of 125, 250, and 500 mg, which is indicated for the treatment of herpes virus infections, including shingles, cold sores, and genital herpes. The generic is available in 30-count bottles.

In April, Camber launched its generic version of Abilify (aripiprazole) tablets, available in doses of 2, 5, 10, 15, 20, and 30 mg. Aripiprazole is indicated for the treatment of schizophrenia, bipolar disorder, and depression.

In February, the company launched two generic products - sildenafil 20-mg tablets and rizatriptan 5- and 10-mg tablets. Sildenafil is used for the treatment of pulmonary hypertension and rizatriptan for the treatment of migraine headaches.

At the end of January, Camber launched pantoprazole sodium delayed-release tablets USP, which are used for the treatment of gastroesophageal reflux disease and damage to the esophagus.

See also: New products for pharmacists 06-10-2015

Dr. Reddy’s

Dr. Reddy’s announced last month the launch of its generic version of Namenda (memantine hydrochloride) tablets, in doses of 5 mg and 10 mg. Memantine HCl is indicated for the treatment for the treatment of moderate-to-severe dementia associated with Alzheimer’s disease. Dr. Reddy’s memantine 5-mg tablets are available in 60-count bottles, and its 10-mg dose is available in 60- and 500-count bottles.

Dr. Reddy’s also announced in July that the company has a new corporate brand identity - Good Health Can’t Wait - and a new company logo. According to a press statement, the new heart-shaped logo is “an expression of empathy and dynamism, which helps keep patients at the center of everything that Dr. Reddy’s does.”

The corporate brand has already transitioned to the new identity. The second phase of the transition will occur soon and will be reflected on the company’s product packaging.

Impax

Impax Laboratories received FDA approval at the beginning of this year for its generic version of Lamictal (lamotrigine) orally disintegrating tablets in the following doses: 25 mg, 50 mg, 100 mg, and 200 mg in blister packaging. Lamotrigine is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. Impax’s generic division, Global Pharmaceuticals, initiated commercialization of the product.

Lupin

In April, Lupin Pharmaceuticals launched combination tablets of amlopidine and valsartan in the following doses: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. The drug is approved to treat hypertension and to lower blood pressure in patients not adequately controlled on monotherapy, and also as an initial treatment in patients likely to need multiple drugs to achieve their blood pressure goals.

In February, Lupin received FDA approval for its bimatoprost ophthalmic solution for the treatment of patients with open-angle glaucoma or ocular hypertension.

The company also received approval for its vancomycin HCl capsules, in doses of 125 mg and 250 mg, for the treatment of Clostridium difficile-associated diarrhea and for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

At the start of 2015, Lupin launched valsartan tablets in dosage strengths of 40, 60, 80, and 120 mg, which are indicated for hypertension and heart failure.

Late last year, Lupin received FDA approval for its lamivudine tablets (150- and 300-mg doses), which are used in combination with other antiviral agents for the treatment of HIV-1.

In December 2014, the company also launched the authorized generic for G.D. Searle’s Celebrex (celecoxib) capsules in 50-, 100-, 200-, and 400-mg strengths for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankolysing spondylitis, and the treatment of acute pain in adults.

Mylan

Mylan announced in July the launch of its generic version of Namenda (memantine hydrochloride tablets USP), in two strengths - 5 mg and 10 mg - for the treatment of moderate-to-severe dementia of the Alzheimer’s type. Mylan is one of the first applicants to submit a complete Abbreviated New Drug Application (ANDA) with a paragraph IV certification and has been granted 180 days of shared generic drug marketing exclusivity.

Mylan also received marketing exclusivity for the U.S. launch of its generic version of Targretin (bexarotene 75-mg capsules). The drug is indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who were refractory to at least one previous systemic therapy.

In June, Mylan introduced in the United States its generic version of Seasonique (ethinyl estradiol tablets USP, 0.15 mg/0.03 mg and ethinyl estradiol tablets USP, 0.01 mg), for the prevention of pregnancy in patients using oral contraceptives.

Mylan also launched its generic Intuniv (guanfacine extended-release tablets, 1 mg, 2 mg, 3 mg, and 4 mg) for the treatment of ADHD as monotherapy or adjunctive therapy to stimulant medications.

In April, the company launched its U.S. generic version of Generess Fe (norethindrone and ethinyl estradiol tablets [chewable], 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg), another oral contraceptive product.

In March, Mylan launched another three generic products in the U.S. market:

• Amlodipine and valsartan (generic version of Exforge) in strengths of 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, and 10 mg/320 mg

• Buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, the generic version of Subutex tablets for the treatment of opioid dependence

• Disulfiram tablets USP, 250 mg and 500 mg, the generic equivalent of Antabuse, a product for the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety.

Mylan also launched its fentanyl transdermal system, 37.5, 62.5, and 87.5 mcg/hr - introducing the first “intermediate” dosage strengths in the U.S. market.

Rhodes

Rhodes Pharmaceuticals announced that it would launch an extended-release formulation of methylphenidate (Aptensio XR), a central nervous disorder stimulant indicated for the treatment of patients with attention-deficit/hyperactivity disorder (ADHD) 6 years of age and older. Approximately 40% of the active ingredient is released immediately and 60% is delivered later in the day. The drug will be available in dosage strengths of 10, 15, 20, 30, 40, 50, and 60 mg. Shipping is expected to commence this summer.

Teva

Teva Pharmaceutical Industries Ltd. launched the first generic version of Axert (almotriptan malate) tablets in the United States, with dose strengths of 6.25 mg and 12.5 mg. The company was the first to submit an ANDA for almotriptan malate tablets containing Paragraph IV patent certification and will have a period of market exclusivity until the pediatric exclusivity expires November 7, 2015. The drug is indicated for the treatment of adults and teens, 12 to 17 years of age, with acute migraine headache.

In July, Teva launched the generic version of Aggrenox (aspirin/extended-release dipyridamole) in the United States. The combination capsules are used to lower the risk of stroke in patients who have had a mini-stroke or stroke caused by a blood clot.

In June, Teva introduced its generic version of Intuniv (guanfacine), in 1-, 2-, 3-, and 4-mg strengths to the U.S. market. Guanfacine extended-release tablets can be used alone or as an add-on to stimulant medications for the treatment of ADHD. They are indicated for patients 6 years of age and older.

Also in June, Teva launched its generic for Actonel (risedronate sodium) tablets in strengths of 5 mg, 30 mg, and 35 mg in the United States. It received 180 days of market exclusivity for this launch. Risedronate sodium is used to treat or prevent osteoporosis in postmenopausal women by helping to increase bone mass and reduce the risk of a spinal or nonspinal fracture. The drug is also used to treat or prevent osteoporosis in men or women who are taking corticosteroids, and to treat Paget’s disease of the bone.

At the end of May, Teva introduced a generic version of Lomedia 24 Fe (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets, 75 mg) for women who want to use an oral contraceptive to prevent pregnancy.

In April, the company launched a generic version of Abilify (aripiprazole) tablets in 2-, 5-, 10-, 20-, and 30-mg dosage strengths, for the treatment of schizophrenia and for the acute treatment of manic and mixed episodes associated with bipolar I disorder.

Teva also launched argatroban injection in 0.9% sodium chloride, 250 mg/250 mL, for intravenous infusion only, in the United States. It is used to prevent and treat blood clots in adults who have developed antibodies to heparin or heparin-like products, resulting in a decrease in platelets. The blood thinner is also used in adults during percutaneous coronary intervention for those patients at risk for heparin-induced thrombocytopenia.

In March, Teva launched a generic version of amlodipine and valsartan (Exforge) tablets in four dosage strengths (5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg).

In February, the company launched the generic version of Lovenox (enoxaparin sodium injection), indicated for the prevention of deep vein thrombosis (DVT) in patients undergoing abdominal surgery or hip or knee replacement, or in patients with severely limited mobility during acute illness. It is also indicated to treat DVT.

The company also introduced its generic version of Zyvox (linezolid) injection, used to treat Gram-positive bacterial infections.

Upsher-Smith

Upsher-Smith’s previously approved Vogelxo (testosterone gel 1%) unit-dose tubes and packets received an AB rating from FDA in February, which determined that Vogelxo is therapeutically equivalent to Testim (testosterone gel). It is indicated for the treatment of adult males who have low or no testosterone and with conditions associated with low or no testosterone. Its testosterone gel is now available in dose tubes, packets, and metered-dose pumps.