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Orphan Designation without Exclusivity: Court asked to decide

Yesterday, Depomed filed suit against the FDA requesting the Court to order FDA to grant their product Gralise (gabapentin) seven years of exclusivity since it was granted Orphan status; upon approval, Gralise was granted three years of exclusivity.

Depomed licensed the product to Solvay which became Abbott via acquisition. Thus the majority of NDA-related regulatory documents indicate the Sponsor as Abbott. Subsequently, Depomed reacquired the assets.

Gralise was filed as a 505(b)(2) referencing Pfizer’s Neurontin, gabapentin immediate-release tablets. Gralise is formulated to swell in the presence of fatty food and release gabapentin over a period of several hours. Abbott sought the postherpetic neuralgia (PHN) indication, which Neurontin has. PHN is an orphan-designated indication. FDA granted orphan designation to Gralise in 2010.

In it’s Complaint, Depomed states that FDA told it that orphan exclusivity was not granted because ” in order to qualify for orphan-drug exclusivity, Gralise had to be shown to be clinically superior to Neurontin..”. Depomed urges the Court to intervene because “clinically superior’, while part of the regulations, is not part of the law. Further, Neurontin was never designated as an orphan drug.

The Orphan Drug Act states that 7 years exclusivity is granted with two (2) exceptions”

Secretary may, during the seven-year period beginning on the date of the application approval, or of the issuance of the license, approve another application under section 505(b) or issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if—
(1) the Secretary finds, after providing the holder notice and
opportunity for the submission of views, that in such period the holder of the approved application, of the certification, or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons
with the disease or condition for which the drug was designated; or
(2) such holder provides the Secretary in writing the consent of such holder for the approval of other applications, or the issuance of other licenses before the expiration of such seven-year period.

The regulations (21 CFR 316.3(b)(13)) cited by Depomed, suggest a third exception based on clinical superiority:

(i) If it is a drug composed of small molecules, a drug that contains the same active moiety as a previously approved drug and is intended for the same use as the previously approved drug, even if the particular ester or salt (including a salt with hydrogen or coordination bonds) or other noncovalent derivative such as a complex, chelate or clathrate has not been previously approved, except that if the subsequent drug can be shown to be clinically superior to the first drug, it will not be considered to be the same drug.

We await the FDA reply and the Court decision.