The TEVA pMDI portfolio: a rare pMDI generic opportunity

The TEVA pMDI portfolio: a rare pMDI generic opportunity

May 16, 2016

pMDI products to genericize are getting rare, but 2 are still worth looking at: and they both come from the TEVA stables: ProAir® and QVAR® pMDI.

Both these pMDI are based on ethanol/HFA mixtures and are essentially solution formulations: therefore one of the easiest type to make generic versions of.

Although these products are “super-generics” of branded products (cf. Clenil® and Ventolin®), they are distinct from the originators and can be considered legitimate targets for generic filing. National authorities are looking for generic versions of these products: the NHS(UK) estimated in 2010 that the annual treatment cost for QVAR is about GBP 63 per patient. A quick price check to purchase QVAR online in the US shows a 600 doses pack cost USD 100 to USD 240, that’s USD 0.16 to USD 0.4 per dose. A number of generic players are engaged in the development of these, and judging from the sales figures, there is space for a few players.

  2015 2014  2013 2012 2011
ProAir® 549 478 429 406 436
QVAR® 392 286 328 297 305

Sales figures in USD MM

ProAir® is a based on albuterol sulfate a short acting beta agonist whose main competitors are Ventolin®, Proventil® and Xopenex®. ProAir® currently holds a market share of 57.1% in terms of total number of prescriptions, and brought in a healthy USD 549 MM revenues in 2015, in constant increase since 2012.

QVAR® is based on beclomethasone dipropionate for the treatment of asthma and as an add-on therapy for combination treatments. QVAR® is the fastest growing inhaled corticosteroid in the United States. Four brands compete directly with QVAR®: Flixotide/Flovent® and Pulmicort. QVAR generated revenues of USD 392 MM in 2015.

Patents and lifecycle management
Interestingly the formulation patents on these products have or will soon expire: 2017 will be a critical year for them. TEVA naturally is not relying solely on formulation patents to fence off competition and introduced some hardware changes to navigate the patents cliff and introduce some generic hurdles. TEVA has done two things: it has introduced a dose counter and invented a new device the Spiromax in which it will most likely transition its molecules one by one as their patents expire. The question is: will it manage to achieve this transition before they do expire?

  Formulation Device

US7105152: Sep 12, 2023
US7566445: Jun 4, 2017
US8834849: Jun 4, 2017

US8132712: Sep 7, 2028
QVAR® None US6446627: Dec 18, 2017

Unexpired patents as listed on the FDA orange book

Any company wanting to file substitutable versions of these products will need to include the dose counter. The good news is that a lack of dose counter would not prevent a 505b2 filing in the US and would certainly not be a barrier to a European filing; in addition dose counter patents can be circumvented by using available dose counting technologies that do not infringe TEVA’s rights.

The formulation patents, essentially claims over the use of ethanol as an additive, will be more difficult to circumvent but options do exist.

Development pathway
The development of generic pMDI for the US would typically require 3-4 years of pharmaceutical development, followed by a review cycle of up to 3 years. These timings can be shortened once the IP landscape is duly reviewed to avoid a 30 months stay for instance, and if filing is carried out with a short term stability data, leaving the bulk of the stability data to be generated during the review. The situation for Europe can be more flexible since in vitro filing is in theory possible this avoiding PK and PD BE delays. The cost of the development of a pMDI would typically lie around the USD 10 MM mark, with 2/3 of these costs spent on clinical studies. A cost of less than USD 0.4 per dose is easily achieved, with a target of 30% of the originator price (i.e. USD 0.1 per dose) once the market is fully genericized. This still represents a worthwhile effort with sizeable sales targets.

ProaAir® and QVAR® are therefore pMDI products to be conquered. It can be done: be in touch.

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