Generics/News
Actavis hit with lawsuit over generic version of weight-loss drug
US-based obesity specialist Orexigen Therapeutics (Orexigen) and its North American partner, Takeda Pharmaceuticals (Takeda), have sued Actavis (Allergan’s US generics business) over its generic version of the weight-loss drug Contrave (naltrexone/bupropion).
Mylan launches generic asthma inhaler in UK
US generics manufacturer Mylan announced on 8 June 2015 that it had launched the first bioequivalent alternative to GlaxoSmithKline (GSK)’s asthma inhaler Seretide/Advair (fluticasone/salmeterol) in the UK.
Generics of ADHD drug launched in US
Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.
Osteoporosis and ADHD generics launched in USA
On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.
FDA receives application for first generic of HIV drug dolutegravir
India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).
Generics of high blood pressure medication launched
On 31 March 2015, generics majors Mylan, Sandoz and Teva Pharmaceutical Industries (Teva) announced the US launch of their respective generic amlodipine and valsartan combination tablets in four dosages.
TWi and Takeda settle dispute over anti-reflux generic
Taiwan-based TWi Pharmaceuticals (TWi) announced on 27 April 2015 that it had entered into a settlement agreement with Takeda Pharmaceutical Company, Takeda Pharmaceuticals USA and Takeda Pharmaceuticals America (Takeda) to settle and dismiss all outstanding patent litigation related to TWi’s generic dexlansoprazole.
FDA approves first generics of antipsychotic drug
The US Food and Drug Administration (FDA) announced on 28 April 2015 the approval of the first generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole).
IDT Australia gets FDA nod for 23 generics
IDT Australia announced on 13 April 2015 that the US Food and Drug Administration (FDA) had accepted the transfer of ownership of 23 generics to the Australia-based company.
Shire grabs Par’s attention with patent lawsuit
Shire has served its rival Par Pharmaceutical (Par) with a patent infringement lawsuit in New Jersey Federal Court over Par's application to market a generic version of Shire's attention deficit hyperactivity disorder medication Adderall XR.
Actavis loses Atelvia patents
Teva Pharmaceutical Industries (Teva) has won a legal battle against Actavis after a federal judge invalidated two patents protecting the post-menopausal osteoporosis drug Atelvia (risedronate sodium delayed-release tablets, 35 mg). Actavis acquired Atelvia in 2013 when it bought Irish drugmaker Warner Chilcott [1], which continues to produce the drug as an Actavis subsidiary.
Ranbaxy fails to reverse FDA decision over Valcyte and Nexium
Indian generics company Ranbaxy has yet again failed in its bid to become the first company in the US to sell generic versions of the AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir). Launching the first generic copies of the drugs would have given Ranbaxy six months of exclusivity on the market.
Drug companies seek to block generic version of ulcerative colitis therapy
The patent holder and manufacturer of Uceris (budesonide), a treatment for ulcerative colitis, have sued generics company Actavis for infringing their drug’s patents. Actavis recently filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Budesonide extended-release tablets, 9 mg.
US court invalidates asthma drug patent
The US District Court of New Jersey ruled on 13 February 2015 that the patent protecting AstraZeneca’s inhaled asthma drug Pulmicort Respules (budesonide inhalation suspension) is invalid, opening the door to competition from generics.
Actavis receives generic opioid approval and plans name change
US generics maker Actavis announced on 20 February 2015 that it had received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Reckitt Benckiser’s Subutex (buprenorphine) sublingual tablets in dosages of 2 and 8 mg.
Mylan being sued over sorafenib generic
US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).
Dr Reddy’s could move manufacturing site with view to FDA approval
Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.
Akorn submits ANDA for difluprednate ophthalmic emulsion
US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.
FDA approves first generic esomeprazole
Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.
Prasco to market authorized colchicine generic in the US
US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute an authorized generic version of Colcrys (colchicine) in the US.
US judge invalidates 4 of 5 patents on Cubicin
A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.
First celecoxib generics hit US market
On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.
FDA withdraws automatic substitution of two methylphenidate generics
The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate). The agency took the action due to concerns that the drugs may not be therapeutically equivalent to the brand-name drug.
Cipla petitions Indian Government to revoke Onbrez patents
India-based generics maker Cipla has asked the Indian Government to revoke five patents held by Swiss firm Novartis for its respiratory drug Onbrez (indacaterol), after launching its own generic version of the drug.
FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs
India-based generics maker Ranbaxy Laboratories (Ranbaxy) announced on 6 November 2014 that the company had been informed by the US Food and Drug Administration (FDA) of the agency’s decision to revoke its approval for the company’s generic versions of AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir).
Mylan latest to recall blood pressure generics
US generics giant Mylan has become the latest in a line of generics companies that have faced recalls of the blood pressure medication metoprolol.
Generics firms carve their way to victory
US generics company Mylan has won a court battle over brand-name drugmaker Hospira, meaning it is now free to resume distribution of generic Precedex (dexmedetomidine injection).
Actavis agrees to continue making Alzheimer’s drug for now
Actavis has agreed to keep selling a top Alzheimer’s disease drug for 60 days so US patients will not be forced to switch to a newer, more expensive form of the drug.
New indication for old generic combination drug
US biopharmaceutical company Avanir Pharmaceuticals has announced positive results from a phase II clinical trial of a generic combination drug for the treatment of agitation in patients with Alzheimer’s disease. The same combination is already approved for a different neurological disorder, and other indications are being investigated.
Phase III trials for generic asthma inhaler and insulin glargine
Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.
FDA approvals for generic AIDs and testosterone drugs
The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.
Teva wins another Symbicort patent challenge
Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.
Generics companies sue Reckitt Benckisser over generics supplies
Three generics companies are suing Reckitt Benckisser (Reckitt) for failing to provide generics supplies of its cold and flu medicine Mucinex (guaifenesin) in line with an agreement struck in 2007.
US court puts generic Gralise on hold
US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment for neuropathic pain, Gralise (gabapentin).
Generics manufacturers focus on MS drug Ampyra
Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.
Blood pressure generics to be included in FDA’s testing plans
The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.
Actavis submits generic dalfampridine ANDA
Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).
Generic valsartan approved in US
India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.
Teva settles patent litigation over ProAir HFA
The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).
Actavis settles Nuvigil patent litigation, challenges Onglyza patent
US generics major Actavis has settled patent litigation related to Actavis’ generic version of Nuvigil (armodafinil) and confirmed its generic Onglyza (saxagliptin) patent challenge.
