Generic Yasmin

[diana.papshev]

Anonymous question from one of our members:

"What is the current status of Ocella (generic Yasmin)? I'm hearing that because of some legal/regulatory things going on with this product, Ocella may be moving to a 'brand' designation. Any insight?"

[diana.papshev]

It does not appear that there are specific legal developments that would change Ocella’s designation; however, technically, it is an authorized generic and can be designated as a brand product because it’s being marketed under Yasmin’s NDA not a separate ANDA.

For the most part, proprietary database publishers code authorized generics as default multi-source generics (Ocella and Adderall XR in FDB are perfect examples) but some plans prefer to code these products as single-source brands (unless an ANDA-based generic is approved).

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Also to make this discussion complete, it’s important to review generic projections for this class of products by distinguishing NDA-based (authorized) versus ANDA-based generics:


Yasmin:

First generic approval/launch forecast:

o Authorized generic – was launched by Barr as Ocella in 7/2008
o ANDA-based generic – expected by 10/2013 or earlier

Background, details, and sources:

o All currently listed patents expire by 8/31/2020 (Sources: FDA’s Orange Book)
o ANDAs with paragraph IV certification have been filed Barr, Watson and Sandoz. Bayer sued all 3 companies – Barr for the ‘531 patent, Sandoz and probably Watson for the ‘652 patent. Bayer and Barr came to an agreement that Barr would launch an authorized generic regardless of the outcome of the trial, which actually Bayer lost. Litigation with Watson and Sandoz is still ongoing; it revolves around the “652 patent which expires by 10/2013 (sources: FDA’s list of Paragraph IV patent certifications); Bayer press release 6/08; Bayer Annual Report 2008; Bayer vs Sandoz complaint; FDA’s Orange Book)
o As part of the agreement, Barr launched Ocella in 7/2008. Although the FDA approved Barr’s ANDA in 5/2008, Barr did not launch generic Yasmin through that market pathway (sources: Drugs@FDA; FDA letter 5/2008; Bayer press release 6/08)

Yaz:

First generic approval/launch forecast:

o Authorized generic - expected by 6/2011 or earlier if other generics are launched
o ANDA-based generic – expected by 5/2014 or earlier

Background, details, and sources:

o All currently listed patents expire by 12/20/2021 (Sources: FDA’s Orange Book)
o ANDA with paragraph IV certification have been filed Barr, Watson and Sandoz. As part of the agreement with Barr, Bayer did not file a lawsuit and the companies agreed to launch an authorized generic regardless of the outcome of the Yasmin trial. Barr pursued the other two companies in court - Sandoz for the ‘652 patent (which expires in 10/2013) and Watson for the ‘534 and ‘838 patents (which expire 6/2014) (sources: FDA’s list of Paragraph IV patent certifications; Bayer press release 6/08; Bayer Annual Report 2008; Patent Docs 9/08; Bayer vs Watson complaint; FDA’s Orange Book)
o As part of the agreement, Barr will launch authorized generic for Yaz in 6/2011. Although the FDA approved Barr’s ANDA in 3/2009, Barr did not launch generic Yaz through that market pathway (souces: Bayer press release 6/08; FDA letter 3/2009; Drugs@FDA)

[Nochmar]

My checking found the following press release. I suspect it was reclassified due to the fact that Bayer is making both products.

Press Release
Teva Announces Appeals Court Ruling Affirming Invalidation Of Yasmin® Patent

Jerusalem, Israel, August 5, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey finding Bayer Schering's U.S. Patent No. 6,787,531 invalid. The patent is listed in the Orange Book for Bayer's oral contraception Yasmin®.

On June 24, 2008, Barr Laboratories, Inc. (now a wholly owned subsidiary of Teva Pharmaceutical Industries, Ltd.) announced that it had entered into a supply and licensing agreement with Bayer for distribution of a generic version of Yasmin®. Under the terms of that agreement, Bayer supplies Barr with the generic product, which Barr distributes in the U.S. under the Barr Laboratories label, Ocella. Ocella was launched in July, 2008 and had annual sales of approximately $170.2M in the United States for the twelve months that ended December 31, 2008, based on IMS sales data.

[chantell.reagan]

Teva launched an at-risk versions of Yaz on 6/1/10, even though they already had an agreement with Bayer to hold off launch until July 1, 2011. However, Watson's 30-month stay on its ANDA just expired 5/10, prompting Teva to reach the market first. (source: News article 6/10)

[Nochmar]

Returning to Diana's previous comment:
"For the most part, proprietary database publishers code authorized generics as default multi-source generics (Ocella and Adderall XR in FDB are perfect examples) but some plans prefer to code these products as single-source brands (unless an ANDA-based generic is approved)"

I think some plans defer the decision by accepting the brand/generic status of their database publisher (MediSpan or First Databank). It's a practical and impartial way to manage the issue.

[chantell.reagan]

This week Watson launched an at-risk generic (called Zarah), which is equivalent to Yasmin. According to their press release, product is available. Bayer's lawsuit against Watson re: the '652 patent remains pending.