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Extending Exclusivity: How Long Will It Really Last?

Last week at the Generic Pharmaceutical Association (GPhA) Annual Meeting, the 21st Century Cures Act, a proposed bill with bipartisan support, was a topic of discussion. Specifically, subtitle L—Dormant Therapies, which would offer 15 years of exclusivity for drugs and biologics approved as dormant therapies. From the House Committee on Energy and Commerce’s bill summary/discussion document:

“The time and expense to develop therapies for complex diseases, such as Alzheimer’s, pose unique challenges that make it harder to bring treatments and cures to market. In many ways, the current framework rewards companies for researching and developing treatments where development is relatively easier and faster, and it discourages investment in therapies for scientifically complex and rare diseases. The Dormant Therapies Act would address this issue by rewarding investment in treatments and cures for patients where there are unmet medical needs.”

We’ve covered the unveiling or unraveling of dormant therapies; at face value, this provision is meant to incentivize innovation of new drugs that meet unmet patient needs. But Ralph Neas, GPhA president and CEO, warned the act could “upset the important balance between creating competition and encouraging innovation …” and spoke to an “overdependence on market exclusivity as an incentive for innovation.” Indeed, Mr. Neas isn’t alone in voicing concern regarding the potential for drug companies to exploit a “dormant therapy’s” ability to meet one or more “unmet clinical needs,” thereby curbing competition from generic drugs even further. However, sponsors would have to waive patent rights if dormant therapy designation is granted.

Also in the act, Subtitle M—New Therapeutic Entities, would stack exclusivity opportunities for some NDAs and ANDAs, including products approved via the 505(b)(2) approval pathway by extending exclusivity from three years to five years for drugs offering significant improvements (new indications, formulations, deliver systems, etc.) to existing molecules. Subtitle M would also offer this added exclusivity for previously approved drugs. In any case, the NDA sponsor must demonstrate that its drug can:

  • Promote greater patient adherence to an approved treatment regime relative to the previously approved formulation or design of the drug;
  • Reduce the public-health risks associated with the drug relative to the previously approved formulation or design of the drug;
  • Reduce the manner or extent of side effects or adverse events associated with the previously approved formulation or design of the drug;
  • Provide systemic benefits to the health care system relative to the previously approved formulation or design of the drug; or
  • Provide other patient benefits that are comparable to the benefits described [above].

121-122, 21st Century Cures Act

Moreover, Subtitle N—Orphan Product Extensions, would offer drugs (not originally approved as orphan drugs) that receive rare disease indication six additional months of exclusivity.

For 505(b)(2) developers this new proposal by Congress is a two-edged sword.  On the one hand, market exclusivities would be extended for many of the changes that are currently go without an award of any exclusivity. Yet, brand companies could put many products out of reach forever.