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.

Mylan launches three HIV generics in Canada

Generics/News | Posted 15/09/2017

US generics giant Mylan Pharmaceuticals (Mylan) announced on 10 August 2017 that it had launched three generic HIV drugs in Canada, after having received final approval for the products from Health Canada.

Teva launches generic testosterone

Generics/News | Posted 08/09/2017

Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.

Adamis gains FDA approval for its EpiPen rival

Generics/News | Posted 25/08/2017

Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.

Endo removes Opana ER opioid from the market

Generics/News | Posted 18/08/2017

The US Food and Drug Administration (FDA) requested that Endo International plc (Endo) remove its opioid medication Opana ER from the market, due to concerns over the ‘public health consequences of abuse’.

Impax launches new high-strength ADHD generics

Generics/News | Posted 11/08/2017

Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).

FDA approval for generics of ADHD drug Strattera

Generics/News | Posted 23/06/2017

The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).

FDA approves two new Seroquel XR generics

Generics/News | Posted 16/06/2017

The US Food and Drug Administration (FDA) has approved two generic versions of Astra Zeneca’s antidepressant Seroquel XR, which has a billion-dollar market in the US.

Vytorin generic launched in the US

Generics/News | Posted 26/05/2017

The US Food and Drug Administration (FDA) has approved a generic version of the anti-cholesterol drug Vytorin, which will be launched on the US market by Impax Laboratories Inc (Impax).

First Advair generic launched in the US

Generics/News | Posted 04/05/2017

Teva Pharmaceutical Industries (Teva) has announced the launch of AirDuo RespiClick and its authorized generic, the first competitor to GlaxoSmithKline's (GSK) best-selling asthma drug Advair in the US.

Patent challenges hit Actavis and Acorda

Generics/News | Posted 28/04/2017

Teva Pharmaceuticals’ subsidiary Actavis and neurological drug specialist Acorda Therapeutics have both faced patent challenges recently over treatments for acne and multiple sclerosis, respectively.

FDA approves Akorn’s mycophenolate mofetil following Form 483 resolution

Generics/News | Posted 07/04/2017

US-based generic pharmaceutical manufacturer, Akorn Inc has announced that its sterile manufacturing site in Decatur, Illinois, USA has received a No Action Indicated (NAI) status from the US Food and Drug Administration (FDA). This is following the sites re-inspection in December 2016.

Generic antidepressant launched in the US

Generics/News | Posted 31/03/2017

US pharma giant Pfizer is facing competition for its antidepressant Pristiq (desvenlafaxine) with generics hitting the market in the US.

FDA approves rare disease deflazacort at exorbitant price

Generics/News | Posted 17/03/2017

Deflazacort is a steroid treatment that has long been approved in many countries outside the US. In February 2016, the US Food and Drug Administration (FDA) approved Marathon Pharmaceuticals’ deflazacort (Emflaza) for the treatment of Duchenne muscular dystrophy. However, it is reported that the drug will come with a devastating price-tag of US$89,000 a year, far more than prices charged abroad.

Generic lung cancer treatment now available in China

Generics/News | Posted 10/03/2017

A generic version of AstraZeneca’s Iressa (gefitinib) has been released onto the market in China. This generic drug is being marketed under the brand name Yiruike and is produced by Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu).

US approves generic of narcolepsy drug Xyrem

Generics/News | Posted 24/02/2017

The US Food and Drug Administration (FDA) has approved the first generic version of Xyrem (sodium oxybate) – the only drug approved to treat the sudden muscle weakness seen in narcolepsy.

Endo launches generic version of Zetia

Generics/News | Posted 27/01/2017

Ireland-based Endo International plc has announced that its operating company Par Pharmaceutical will ship the first generic version of Merck & Co’s blockbuster cholesterol medication Zetia.

Natco Pharma and Alvogen launch first US Tamiflu generic

Generics/News | Posted 20/01/2017

Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.

Mylan launches generic EpiPen

Generics/News | Posted 13/01/2017

US-based drugmaker Mylan announced on 16 December 2016 that it had launched the authorized generic version of its EpiPen (epinephrine) injectors at a wholesale price of US$300 per two-pack. This price, the company says, ‘is more than 50% lower’ than the brand-name price.

Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA

Generics/News | Posted 06/01/2017

The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.

Mylan to make generic hepatitis drug under MPP sublicence

Generics/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

Dr Reddy’s makes deal with Gland Pharma for US injectables

Generics/News | Posted 18/11/2016

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 October 2016 that it had entered into a ‘strategic collaboration’ with India-based sterile dosage form maker Gland Pharma.

Teva sells Actavis’ UK and Ireland generics business to Intas

Generics/News | Posted 28/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 5 October 2016 that it had agreed to sell the UK and Ireland generics business of Actavis to Accord Healthcare (a subsidiary of Intas Pharmaceuticals) for GBP 603 million, subject to final approval from the European Commission (EC).

Mylan agrees to pay fine over EpiPen rebates

Generics/News | Posted 21/10/2016

US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.

Teva recalls antibiotic and anti-seizure drug

Generics/News | Posted 30/09/2016

Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.