Generic Prevacid

[MitchellM]

My understanding is that Teva will release lansoprazole no later than Nov. 10th. Does Teva have a 6 month exclusivity? I heard there would be another generic manufacturer. Thanks

[chantell.reagan]

Although there is no publically available information about the exclusivity of the expected Teva generic, we can assume that they are eligible for the 6 month exclusivity based on 3 factors:

o It appears that the first to file an ANDA for Paragraph IV certification in 12/05 was Teva
o There is no record that Takeda was in litigation with other generic companies to the same extent as they were with Teva
o Teva is the only company granted a tentative approval for their generic by the FDA

Sources:
Teva preliminary injunction 6/09
Teva press release 11/08
Drugs@FDA
Paragraph IV certifications

[chantell.reagan]

Upon inquiry, Teva confirmed the availability of the lansoprazole 15, 30mg generic as of this week (source: News article 11/09)

Related link:
FDA update on generic drugs for November 12, 2009

[Nochmar]

What I'm seeing is the OTC is priced approximately where Prilosec OTC is, and the generic Rx capsules are priced slightly below pantoprazole.

[diana.papshev]

Anonymous feedback:

"How it it allowed to deploy lansoprazole 15mg capsule Rx product when the drug launched as an OTC by Novartis? I thought the patent moved to the OTC and the Rx product was no longer allowed to be made (like Zyrtec)?"

[diana.papshev]

Key update - a second generic lansoprazole has been approved. According to a recent statement by Mylan/Matrix, it's being shipped immediately (latest news article).

Just proves one more time that until the product is launched there might be very little information in the public domain.

[diana.papshev]

Technically, there are no patent issues preventing marketing of the same dose of an Rx and an OTC product; it's probably more based on the marketing strategy... Prevacid 24HR is protected by a 3-year exclusivity for the OTC market only (see Novartis press release, 7/2009).

[diana.papshev]

Anonymous response:

"Takeda sold the rights to Novartis. But my understanding is the classification of the patent...not the marketing rights. The classification is moving to OTC....therefore a Rx product should not exist.

With Zyrtec, the patent moved to an OTC status where a brand and generic OTC's were produced but the Rx product was forced to deplete and no generic companies were allowed to produce Rx product.

The same happened with Miralax. Once it was launched OTC, branded Rx product was not allowed to be manufactured (even though generic Rx was manufactured) and eventually all brand and generic Miralax Rx ceased being manufactured."

[diana.papshev]

Manufacturers can pursue one of the following strategies
when requesting Rx-to-OTC switch:

- Full OTC status - where no Rx products would be available (ex: Miralax and Zyrtec)
- Dual Rx/OTC status - where OTC products would differ from Rx products in terms of formulation, strength, dosing, and/or indications. In some cases, when a brand is switched to a dual status, different formulations are used for Rx and OTC products (ex: Prilosec). In others, the difference might be in the strength (ex: Benadryl capsules) But technically, the OTC status can apply to a particular dosing, formulation, indication, packaging, or other attributes.

In the case of Rx and OTC lansoprazole 15 mg, there are differences in indications:

- Rx product is indicated for the treatment of ulcers, treatment of GERD (up to 8 weeks in adults and children 12 years or older; up to 12 weeks in children between 1 and 11 years old), maintenance of erosive esophagitis, and pathological hypersecretory conditions. [indications for a generic product should mirror those for a branded product]
- OTC product is indicated for the treatment of frequent heartburn (heartburn occurring 2 or more days a week) with a 14-day course of treatment (can be repeated every four months)

The issue is that many of the Rx PPI indications are not for self-diagnosis by patients, unlike with Zyrtec and Miralax. Also, whatever the strategic reasons were, Novartis/Takeda did not follow the Prilosec OTC scenario, where the OTC product has a different formulation (tablet) than the Rx product (capsule)...

So, the only discernible difference between lansoprazole 15 mg OTC and Rx is in the scope of indications. In addition, no regulatory restrictions for the generic Rx lansoprazole have been announced in the FDA's approval letter (Teva also posted the details for the launched 15-mg generic).

Related resource:
The Food and Drug Letter, December 2002
List of switched products