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US judge invalidates 4 of 5 patents on Cubicin

Generics/News | Posted 16/01/2015

A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.

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First celecoxib generics hit US market

Generics/News | Posted 12/12/2014

On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.

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FDA withdraws automatic substitution of two methylphenidate generics

Generics/News | Posted 28/11/2014

The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate).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.

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Cipla petitions Indian Government to revoke Onbrez patents

Generics/News | Posted 21/11/2014

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.

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FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs

Generics/News | Posted 14/11/2014

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).

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Mylan latest to recall blood pressure generics

Generics/News | Posted 31/10/2014

US generics giant Mylan has become the latest in a line of generics companies that have faced recalls of the blood pressure medication metoprolol.

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Generics firms carve their way to victory

Generics/News | Posted 24/10/2014

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).

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Actavis agrees to continue making Alzheimer’s drug for now

Generics/News | Posted 10/10/2014

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.

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New indication for old generic combination drug

Generics/News | Posted 03/10/2014

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.

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Phase III trials for generic asthma inhaler and insulin glargine

Generics/News | Posted 26/09/2014

Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.

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FDA approvals for generic AIDs and testosterone drugs

Generics/News | Posted 19/09/2014

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.

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Teva wins another Symbicort patent challenge

Generics/News | Posted 12/09/2014

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.

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Generics companies sue Reckitt Benckisser over generics supplies

Generics/News | Posted 05/09/2014

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.

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US court puts generic Gralise on hold

Generics/News | Posted 29/08/2014

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).

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Generics manufacturers focus on MS drug Ampyra

Generics/News | Posted 22/08/2014

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.

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Blood pressure generics to be included in FDA’s testing plans

Generics/News | Posted 16/05/2014

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.

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Actavis submits generic dalfampridine ANDA

Generics/News | Posted 08/08/2014

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).

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Generic valsartan approved in US

Generics/News | Posted 01/08/2014

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.