The critical aspects of patents and exclusivity relevant to drug development and approval in USA

The FDA/CDER SBIA Chronicles, the newsletter of the CDER Small Business and Industry Assistance team, provides useful information to assist the industry in all aspects of drug marketing and regulation.

The newsletter issues are archived at http://www.fda.gov/cdersmallbusinesschronicles.


The last publication was on 19 May 2025. It outlines the critical aspects of patents and exclusivity relevant to drug development and approval. It emphasises the importance of understanding these concepts for both innovator drug sponsors and generic manufacturers.


Patents:

A patent is a property right granted by the USPTO, allowing inventors to exclude others from making, using, or selling their invention, typically for 20 years from the filing date. Patent information is essential during the drug application process.

  • Submission: Applicants must submit patent information with original NDAs and supplements using FDA Form 3542a before approval. Post-approval, updates are submitted via FDA Form 3542 for publication in the Orange Book. A 30-day window exists after NDA approval for timely patent filing.
  • Scope: The FDA publishes patent information in the Orange Book, focusing on patents related to active ingredients, drug product compositions, and approved uses. 


Exclusivity:

Exclusivity grants exclusive marketing rights from the FDA upon drug approval, potentially running alongside patents. It prevents the approval of ANDAs or applications under Section 505(b)(2) of the Act, balancing innovation and generic competition.


Types: The document details several types of exclusivity:

  1. Orphan Drug Exclusivity (ODE): This provides a 7-year period for drugs treating rare diseases (affecting fewer than 200,000 people in the U.S.). It bars the approval of other applications for the same drug for the same condition.
  2. New Chemical Exclusivity (NCE): A 5-year period for drugs with no previously approved active moiety. It prevents ANDA submissions for drugs with the same active moiety.
  3. "Other" Exclusivity: A 3-year period granted for drug changes requiring new clinical investigations. It restricts ANDA approvals for similar drugs based on the same information.
  4. Pediatric Exclusivity (PED): This adds 6 months to existing patents/exclusivity. It is granted when pediatric studies are conducted in response to an FDA Written Request.
  5. 180-Day Exclusivity: This applies to ANDAs for generic drugs. Under the Hatch-Waxman Act, the first company to submit an ANDA can market the generic exclusively for 180 days.


CDER Exclusivity Board:

The CDER Exclusivity Board provides oversight and makes recommendations on exclusivity determinations to ensure consistency. It focuses on key exclusivity areas such as 5-year NCE, 3-year clinical trial, and biological product exclusivity, aiming to resolve specific matters and issues.


Other Considerations:

  • The GAIN Act may grant an additional five years of exclusivity for products with the designation of Qualified Infectious Disease Product (QIDP).
  • Under the Generating Antibiotic Incentives Now (GAIN) Title VIII of the FDA Safety and Innovation Act (FDASIA), at the time of approval, the FDA will grant an additional five years of exclusivity to certain products that have received a Qualified Infectious Disease Product (QIDP) designation (with some exceptions).
  • The FDA shares exclusivity information through the Orange Book. Patents and exclusivity can run concurrently or independently.
  • It is important to note that the FDA does not send letters to the sponsor to indicate the grant of exclusivity. The Orange Book serves as the official vehicle for disseminating this information.
In summary, patents and exclusivity are critical for pharmaceutical innovation and competition. Patents provide temporary market exclusivity to protect inventions, while FDA-granted exclusivities incentivise the development of treatments for rare diseases, new chemical entities, and paediatric populations, fostering a balance between innovation and generic drug availability.


Comments

Post a Comment

Popular posts from this blog

Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

Image
This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL. Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025. Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure. Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone. Several patents are listed in OB by La Jolla Pharma’s Giapreza product.  Product...
Read more

Medical Reimbursement System in the US, J-Code, and the Potential Impact on 505(b)(2) Applications with Recent Changes

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...
Read more