Table of Contents
What does market exclusivity mean?
Marketing exclusivity is a key incentive for drug developers. It provides a fixed period of time following drug approval during which the Sponsor can market their drug without direct competition from manufacturers of duplicate or reformulated products.
What is the difference between data and market exclusivity?
Data exclusivity is a form of product exclusivity right for medicinal products in Europe, and market exclusivity is a related form of additional protection. These two rights are in addition to any granted patent exclusivity right covering a medicinal product.
How long is market exclusivity?
This regulatory exclusivity typically runs for at least six years for new drugs. Certain drugs are eligible for 10 to 12 years of regulatory exclusivity, such as those approved to treat certain infectious diseases and newly approved biologic products used to treat conditions like rheumatoid arthritis and cancer.
What is FDA exclusivity?
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.
What is new product exclusivity?
New Drug Product Exclusivity is provided by the Federal Food, Drug, and Cosmetic Act under section 505(c)(3)(E) and 505(j)(5)(F). Exclusivity provides the holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product.
What is regulatory data exclusivity?
“Data exclusivity” refers to the period in which certain information that has been provided to a regulatory authority for the purposes of obtaining regulatory approval, remains confidential, or cannot be relied upon by the regulatory authority or a third party in order to obtain regulatory approval of a follow-on …
What is a global marketing Authorisation?
Thus, the global marketing authorisation contains the initial authorisation and all variations and extensions thereof, as well as any additional strengths, pharmaceutical form, administration routes or presentations authorised through separate procedures, including in different Member States within the EU, and under a …
What is CGT exclusivity?
The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.
What is the purpose of an exclusivity agreement?
Also known as lock-out, shut-out or no-shop agreements. Agreements which are used to try to ensure that the other party to a prospective deal negotiates solely with the client for a period of time. They aim to give the client some protection from another party outbidding them.
What does exclusive product mean?
Related Definitions Exclusive Product means a Licensed Product as to which an Opt-In Right has not arisen or, having arisen, has not been exercised within the Opt-In Period.
What is loss of exclusivity Pharma?
What is Loss of Exclusivity? When a new prescription drug is launched by a pharmaceutical manufacturer, that manufacturer maintains the legal right to develop, sell, and market the drug for a set amount of time, generally around 10-15 years, depending on the drug type.
What is data exclusivity in Europe?
The period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine.
What is pharmaceutical sunset clause?
The Sunset Clause timer stops running when even a single member state places a medicinal product on the market. It also stops when after temporary cessation of the product, the product is placed on the market once again.
What is a marketing authorisation MHRA?
HOW MARKETING AUTHORISATIONS ARE GRANTED. Before a marketing authorisation is granted for a medicinal product, the efficacy, safety and quality of the product are assessed. 2,3,8 At the MHRA, applications for marketing authorisations are assessed by medical, pharmaceutical and scientific assessors, and statisticians.
What is CGT in pharmaceutical industry?
Earlier this week, the FDA approved potassium chloride oral solution which is the first generic drug to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway has been created as part of the FDA’s broader Drug Competition Action Plan.
What is competitive generic therapies?
Competitive Generic Therapies (CGT) is a designation for products that have inadequate generic competition in the market due to low market potential, less profit margin or complexity in manufacturing the drug product.
What is marketing exclusivity and how does it work?
Marketing exclusivity is a key incentive for drug developers. It provides a fixed period of time following drug approval during which the Sponsor can market their drug without direct competition from manufacturers of duplicate or reformulated products.
What’s the difference between drug pricing and patent and exclusivity?
On the surface, pricing, patents, and exclusivity seem fairly straightforward. Pricing allows drug developers to recoup capital investments (plus profit). Patents protect intellectual property rights and marketing exclusivity prevents competitors from flooding the market with their own versions of the drug for a designated period of time.
What is biologic exclusivity and how does it work?
Biologic exclusivity conveys 12 years of total market protection. This includes 4 years before an application for a biosimilar (essentially a generic form of a biologic drug product) may be submitted to the FDA and 8 additional years before an application may be approved.
Is the exclusivity period added to the life of a patent?
Importantly, the exclusivity period is not added to patent life, so Sponsors will need to be mindful of both durations and plan accordingly. The most common types of exclusivity are described in 21 CFR 314.108.