Estimating generic availability for nasal steroids

[chantell.reagan]

As requested by our members, the following is next in the series of estimating generic availability for nasal steroids:



Beconase AQ

First generic approval/launch forecast:

o Pending ANDA filing/approval

Background, details, and sources:

o There are no unexpired patents or exclusivities (Sources: FDA’s Orange Book)
o No ANDAs with Paragraph IV certification have been submitted. (Sources: FDA paragraph IV list)
oAs of 1/10, the FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

Nasacort AQ

First generic approval/launch forecast:

o Expected in 6/2011

Background, details, and sources:

o All currently listed patents expire by 7/3/2016 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 12/05 (Barr/Teva appears to be first to file). In 5/06, sanofi aventis filed a patent infringement lawsuit against Barr/Teva. In 11/08, a settlement was reached, allowing Teva to market the generic by 6/15/2011 if the ANDA is approved or authorized generic by 12/1/2013 if ANDA is not approved by then (Sources: Barr press release 5/06; sanofi aventis press release 11/08); News article 11/08; FDA paragraph IV list)
o In 7/09, the FDA approved a final version of Barr/Teva's generic; however, due to the terms of settlement it will not be launched until 6/2011 (Sources: Drugs@FDA)

Nasonex

First generic approval/launch forecast:

o Expected by 4/2018

Background, details, and sources:

o All currently listed patents expire by 4/3/2018 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 8/7/09 (Apotex appears to be first to file). In 12/09, Schering/Merck filed a patent infringement lawsuit against Apotex. In question are the '699, '353 and '713 patents; litigation is ongoing (Sources: patent docs 12/09; news article 12/09; FDA paragraph IV list)
o The FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

Omnaris

First generic approval/launch forecast:

o Expected after 10/2011

Background, details, and sources:

o All currently listed patents expire by 10/21/2020 (Sources: FDA’s Orange Book)
o No ANDA with paragraph IV certification has been filed
yet; due to the NCE (new chemical entity) exclusivity being effective until 10/20/2011, ANDAs with paragraph IV certification cannot be submitted before 10/2010 (Sources: FDA’s list of Paragraph IV patent certifications)
o As of 1/10, the FDA has not yet issued any approvals for generic equivalents; final approvals can be issued after 10/2011 due to the NCE exclusivity (Sources: Drugs@FDA)

Rhinocort

First generic approval/launch forecast:

o Pending ANDA filing/approval

Background, details, and sources:

o All currently listed patents expire by 10/29/2017 (Sources: FDA’s Orange Book)
o Starting in 5/2007, at least 1 ANDA with a paragraph IV certification has been submitted (Apotex was first to file). AstraZeneca decided not to file a patent infringement suit against Apotex and will not maintain or enforce the patents referred to in the letter and have requested their de-listing from the US FDA Orange Book. (Sources: FDA’s list of Paragraph IV patent certifications; AstraZeneca annual report 2008)
o Since most ANDA applications are approved within 18-24 months, it is likely that the generic will be approved in the near future. However, as of 1/10, the FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

Veramyst

First generic approval/launch forecast:

o Expected by 8/2021

Background, details, and sources:

o All currently listed patents expire by 8/3/2021 (Sources: FDA’s Orange Book)
o No ANDA with paragraph IV certification has been filed (Sources: FDA’s list of Paragraph IV patent certifications)
o As of 1/10, the FDA has not yet issued any approvals for generic equivalents of fluticasone furoate (Sources: Drugs@FDA)

Note fluticasone propionate is already available as a generic (Flonase)

[diana.papshev]

Anonymous member request:

"I'd like to see where folks might be thinking or at with respect to the nasal steroid class. In Q2 2011, (the specific date I am uncertain of) it appears Nasacort AQ will become available generically. This makes three generic nasal steroids (NSs) that will then be on the market. My questions are: 1) Will plans have the generics are preferred and move all other branded NSs to non-preferred? 2) Will plans still retain some preferred branded NSs along with adding generic Nasacort AQ to the formulary? 3) What other options are being considered? Step therapy with generic agents first?"

A NOTE FROM THE MODERATORS:

You can provide your feedback with FULL ANONYMITY and in UNDER A MINUTE, just click on the button below:

[diana.papshev]

The survey has been conducted between May 10th and 13th.

[chantell.reagan]

Since our initial post in January 2010, the generic forecast for nasal steroids remains practically the same (see details below):

[diana.papshev]

Additional survey comments:

#1:

"Will treat Nasacort AG is a generic and will keep one brand in preferred position."

#2:

"Nasacort AQ is a small product for us. Generic Flonase is huge followed by a decent Nasonex share."

#3:

"Until one of the upper echilon products (Veramyst, Nasonex, Rhinocort) becomes generic, we will likely keep one brand on formulary without restriction."

#4:

"FYI, the strategy above is for Medicare Part D formularies."

[diana.papshev]

Additional survey comments (continued)

#5:

"Continue to encourage use of fluticasone prior to generic Nasacort AQ"

[diana.papshev]

Here's an interesting comparison chart that was shared with us by Advocate Physician Partners PHO in the Chicago metropolitan area and distributed to 3,800 of their members (click on the link to see the chart).

[diana.papshev]

Survey Results:

[diana.papshev]

Anonymous feedback:

"Step therapy with a trial of at least one generic first-line and then bid out the category for a single preferred tier-2 brand. All others will be tier-3 non-preferred and pts will need to step thru both generic and preferred brand to get to a tier-3 agent."