Data exclusivity
Licensing an originator medicine requires submission of clinical and non-clinical data. Licence applications for generic or biosimilar medicines can refer to the data in the originator’s application instead of using new data. This saves time and money.
Medicines regulators grant manufacturers of originator medicines exclusive rights to their own data for a period of time. This is known as regulatory data protection or data exclusivity. The data exclusivity period lasts for eight years after an originator medicine is licensed. It prevents generic or biosimilar manufacturers from using the clinical or pre-clinical data in the originator’s product licence application for their own applications.
This regulatory protection applies independently of any patents that may be in place.
Market protection
Market protection rules prevent generic or biosimilar competition for up to 11 years after a new drug is licensed, regardless of patent protection. This is known as the “8+2+1” rule.
Market protection for all new drugs
Medicines regulators grant market protection to manufacturers of originator medicines. The market protection period lasts for ten years after the originator medicine is licensed. Data exclusivity and market protection run concurrently. Thus, market protection extends two years after the data exclusivity period.
During the market protection period, a generic or biosimilar licence may be granted but the product cannot be placed on the market.
This ensures that originators always receive a reasonable period of exclusivity, even if development has taken so long that patents have expired.
Example
Tecfidera® (dimethyl fumarate) lost data exclusivity at the end of January 2022. Some generic formulations were granted licences in December 2022. However, generics could not be launched until 2024, when market protection expired.
Protection for new indications
An additional year of protection may be granted if the originator adds one or more significant new indications to its product licence during its first eight years. Once an originator drug has been licensed for more than eight years, new indications are not eligible for extra market protection in this way.
Example
Imnovid® (pomalidomide) was granted an additional year of market protection when treatment of multiple myeloma in combination with bortezomib and dexamethasone was added to the licence.
Orphan medicines
Orphan medicines can have up to twelve years of market exclusivity.
More information about orphan medicines is available from the MHRA.
Orphan medicine rules
Orphan medicines are licensed for the diagnosis, prevention, or treatment of rare life-threatening or chronically debilitating conditions where no other satisfactory options exist. “Rare” means that the prevalence of the disease in the UK must not be more than 5 in 10,000 people.
The manufacturer must apply for orphan designation if they want it. If a medicine is granted orphan status for an indication, it is granted market exclusivity for that indication only, for up to 10 years. This means that no similar medicines will be licensed for that indication during the 10-year exclusivity period. A new licensed orphan indication will trigger its own 10-year market exclusivity period.
Orphan medicines with a completed paediatric investigation plan included in the product information may be granted an additional two years of market exclusivity.
The MHRA grants orphan status at the point of granting a product licence. The European Medicines Agency grants orphan status in advance, sometimes many years before a product licence is granted. However, in both cases, the 10 years of market exclusivity run from the date of grant of a marketing authorisation.
Market exclusivity for orphan medicines runs in parallel with normal rules for data exclusivity and market protection.
Orphan and non-orphan indications are not allowed in the same marketing authorisation.
Orphan designation of an existing drug
A medicine may be granted orphan status for a particular indication, even if the drug itself is available as a generic or biosimilar formulation for other indications. This is because orphan status is intended to encourage investigation and repurposing of older drugs for rare conditions, as well as new drug development.
Example
Hydroxycarbamide has been available for many years licensed for the treatment of chronic myeloid leukaemia and cervical cancer (originally as Hydrea®). One brand (Siklos®) was granted orphan status for prevention of vaso-occlusive crises in sickle cell syndrome in 2003. It was granted a licence in 2007 and its orphan status expired in 2017, allowing other brands to be licensed for this indication.
Data exclusivity and market protection in context
Data exclusivity and market protection work with patents to protect new drug molecules.
To understand how these different factors work together, see our article Understanding generic and biosimilar market entry.