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More About Generic Challenge To Anti-Multiple Myeloma Oral Chemotherapy Drug, Revlimid, Using FDA’s Abbreviated New Drug Application Process

Home/Uncategorized/More About Generic Challenge To Anti-Multiple Myeloma Oral Chemotherapy Drug, Revlimid, Using FDA’s Abbreviated New Drug Application Process

More About Generic Challenge To Anti-Multiple Myeloma Oral Chemotherapy Drug, Revlimid, Using FDA’s Abbreviated New Drug Application Process

Yesterday I had a little fun with the “what if” game. What if there was a generic form of Revlimid? How would that affect patients and future drug development if all of those long term profits were lost?

My article was inspired by this news:
Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a “Paragraph IV” patent certification, for REVLIMID (lenalidomide) 25 mg capsules.

Common sense–and the fact I have two patent attorneys in my family–told me it was unlikely this new ANDA would ever be approved. Far from an expert, I started to research the process, using Wikipedia and the FDA’s own info sites. Here is what I found out:

According to Wikipedia, The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

The site went on to say:
The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers.
Challenging patents
Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition. This may involve aggressive litigation to preserve or extend patent protection on their medicines, a process referred to by critics as “ever greening”. Patents are typically issued on novel pharmacological compounds quite early in the drug development process, at which time the ‘clock’ to patent expiration begins ticking. Later in the process, drug companies may seek new patents on the production of specific forms of these compounds, such as single enantiomers of drugs which can exist in both “left-handed” and “right-handed” forms, different inactive components in a drug salt, or a specific hydrate form of the drug salt. If granted, these patents ‘reset the clock’ on patent expiration. These sorts of patents may later be targeted for invalidation (“paragraph IV certification”) by generic drug manufacturers.

So let the games begin! Let’s see what the FDA had to say at

Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days.
To begin the FDA approval process, the generic applicant must: 1) certify in its ANDA that the patent in question is invalid or is not infringed by the generic product (known as “paragraph IV certification”); and 2) notify the patent holder of the submission of the ANDA. If the patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic drug is automatically postponed for 30 months, unless, before that time, the patent expires or is judged to be invalid or not infringed. This 30-month postponement allows the patent holder time to assert its patent rights in court before a generic competitor is permitted to enter.

That’s a lot to digest… I can sense your eyes “glazing over” already! Jut stick with me a few more minutes.

Here is confirmation of the news, challenging Celgene’s exclusive right to produce 25 mg Revlimid capsules:

Paragraph IV Patent Certifications
As of August 23, 2010
Here is the list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a “Paragraph IV” patent certification:

This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/04). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 240-276-8400, before making any decisions based on this information.
Paragraph IV Patent Certifications
Adefovir Dipivoxil Tablets 10 mg Hepsera 6/8/2010
Lenalidomide Capsules 25 mg Revlimid 7/12/2010
Pregabalin Oral Solution 20 mg/mL Lyrica 5/19/2010
Rasagiline Mesylate Tablets 0.5 mg and 1 mg Azilect 5/17/2010
Applicant Tradename Generic Name NDA Approval Date Type RLD Patent Number Product Substance Delist Req. Patent Expiration Exclusivity Expiration CelgeneREVLIMIDlenalidomide021880Dec 27, 2005RXNo5,635,517YOct 4, 2019
CelgeneREVLIMIDlenalidomide021880Dec 27, 2005RXNo6,045,501Aug 28,2018
CelgeneREVLIMIDlenalidomide021880Dec 27, 2005RXNo6,281,230Jul 24, 2016

We can learn a lot from this FDA posting.
Note Celgene’s initial patent is set to expire mid 2016. And isn’t it interesting how the unnamed challenger to Celgene’s patent(s) only lists Revlimid in the 25 mg size. One surprising fact: According to the published timetable, this process moves right along, taking less than a year.

What are the chances for success by our “challenger?” Only one or two percent. So
don’t lose any sleep worrying about Celgene! Even in the unlikely event this, or one of the many future challenges to their right to exclusively manufacture Revlimid proves successful, I’m sure they will time pomalidomide’s release to more than cover their anticipated losses. Sound cynical? Let’s save speculation about jaded, hardened business timing (NO–a drug company timing the release of a chemotherapy drug in their own profitable self interest? Shocking!– NOT!) for tomorrow’s post: Rumors and conspiracy theories involving Celgene, Thalomid, Revlimd and Actimid (CC-4047 or pomalidomide).

Feel good and keep smiling! Pat