Generics/News

Hikma launches HIV generic ritonavir in the US

Generics/News | Posted 18/05/2018

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 mg) in the US.

Alvogen receives European approval for generic lenalidomide

Generics/News | Posted 11/05/2018

US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.

Teva launches ulcerative colitis generic in the US

Generics/News | Posted 27/04/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 26 March 2018 that it had launched generic mesalamine delayed-release tablets (1.2 g) in the US.

Australia’s Mayne Pharma launches generic antibiotic in US

Generics/News | Posted 13/04/2018

Australia-based Mayne Pharma announced on 15 March 2018 that it had launched a generic version of doxycycline monohydrate immediate release (IR) capsules (50, 75 and 100 mg) in the US.

GSK fined GBP 37.6 million in pay-for-delay appeal

Generics/News | Posted 30/03/2018

GlaxoSmithKline (GSK) has lost its appeal over a pay-for-delay case dating back to the early 2000s and involving its now off-patent antidepressant Seroxat/Paxil (paroxetine).

Lupin launches generic memantine XR capsules in the US

Generics/News | Posted 16/03/2018

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 February 2018 that it had launched a generic version of Allergan’s Alzheimer’s disease treatment Namenda XR (memantine XR).

Price of Teva’s new rare disease generic shocks patients

Generics/News | Posted 02/03/2018

On 9 February 2018, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of its generic version of Syprine (trientine hydrochloride) capsules, 250 mg, in the US. However, what the company termed a ‘lower-cost generic alternative’ has turned out to be almost as expensive as the originator product.

Hospitals to start own generics company

Generics/News | Posted 26/01/2018

In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have made plans to create a non-profit generics company.

Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies

Generics/News | Posted 19/01/2018

On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to.

Mylan/Aspen launch generic busulfan injection

Generics/News | Posted 08/12/2017

US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).

Drugmakers waking up to potential value of branded generics

Generics/News | Posted 01/12/2017

Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a branded generic.

FDA tentatively approves pemetrexed generic

Generics/News | Posted 24/11/2017

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).

EMA approval for tacrolimus generic

Generics/News | Posted 10/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.

Lupin launches generic pain-relief med in US

Generics/News | Posted 27/10/2017

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.

FDA approves lidocaine ointment generic from Vitruvias Therapeutics

Generics/News | Posted 13/10/2017

US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.

Indivior to appeal US ruling on opioid addiction patent

Generics/News | Posted 22/09/2017

UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.