Competitive Generic Therapy Approvals
•February 17, 2026
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Why It Matters
The disclosure clarifies which products are protected by CGT exclusivity, helping generic developers plan submissions and avoid costly delays, while signaling the FDA’s commitment to fostering competition in underserved therapeutic areas.
Key Takeaways
- •FDA releases bi‑weekly CGT ANDA approval list.
- •List shows eligibility and forfeiture of 180‑day exclusivity.
- •First‑to‑market must launch within 75 days to retain exclusivity.
- •Data helps applicants anticipate blocked approvals and exclusivity expiry.
- •Orange Book also displays CGT exclusivity expiration dates.
Pulse Analysis
The Competitive Generic Therapy (CGT) framework, introduced under section 506H of the FD&C Act, was designed to encourage generic entry for drugs lacking sufficient competition. By making a searchable, regularly updated list of CGT‑designated ANDA approvals, the FDA provides a clear view of which products have earned the 180‑day exclusivity and which have forfeited it. This transparency reduces uncertainty for manufacturers, allowing them to assess market entry timing and evaluate the risk of blocked approvals due to existing exclusivity periods.
For generic developers, the list serves as a strategic planning tool. It identifies the exact dates when exclusivity begins, the eligibility criteria, and any forfeiture outcomes, which are critical for forecasting launch windows and aligning regulatory submissions. Companies can now pinpoint opportunities where a CGT exclusivity has expired or was never granted, thereby targeting therapeutic gaps with higher confidence. Moreover, the inclusion of the Orange Book’s CGT code offers a cross‑reference point, ensuring that stakeholders have consistent data across FDA resources.
From an industry perspective, the public CGT approvals list signals a more data‑driven approach to managing drug competition. It highlights the FDA’s intent to monitor and enforce the CGT provisions, potentially accelerating the introduction of lower‑cost alternatives for patients. As the list matures, analysts will be able to track trends in CGT utilization, assess its impact on drug pricing, and gauge how effectively the policy is closing gaps in generic availability. This insight supports investors, policymakers, and healthcare providers in making informed decisions about the evolving pharmaceutical landscape.
Competitive Generic Therapy Approvals
Office of Generic Drugs Provides Public List of Approved ANDAs with Competitive Generic Therapy (CGT) Designations
The Office of Generic Drugs is providing a public list of all approved abbreviated new drug applications (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The list also notes which ANDAs cover drug products that were eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
The list will be updated on a bi‑weekly basis with new ANDA approvals where at least one of the drug products (i.e., one of the strengths in the approved application) received a CGT designation.
The Agency is including the following information for individual drug products on the CGT Approvals List:
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Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number – This column reflects the proprietary name, if any, of the RLD and its NDA number.
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ANDA Number
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ANDA Applicant
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Active Ingredient Name, Dosage Form, Strength – This column reflects the established (non‑proprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s).
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Date of Approval – The date on which an ANDA for a CGT‑designated drug product received final approval.
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Eligible for CGT Exclusivity – Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act. A “Yes” indicates eligibility at the time of approval; “No” indicates ineligibility; “Deferred” indicates that FDA has not yet made a determination.
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CGT Exclusivity Forfeiture – Indicates whether a drug product that was eligible for CGT exclusivity forfeited that eligibility because it was not commercially marketed within 75 days after the ANDA’s approval (section 505(j)(5)(D)(iv) of the FD&C Act). “Yes” = forfeiture; “No” = no forfeiture; blank = determination pending; “N/A” = not eligible; “Relinquished” = voluntarily given up.
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Date of First Commercial Marketing of CGT with Exclusivity – The date of first commercial marketing of a CGT by a first‑approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit it. The 180‑day CGT exclusivity period described in section 505(j)(5)(B)(v) is triggered by this first commercial marketing and blocks approval of an ANDA for a drug that is the same as the CGT. If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column shows “N/A.”
FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties regarding the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity. This information should help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (there is only one exclusivity period for each CGT). By providing the commercial‑marketing start date for CGT exclusivity periods, the list also offers useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity, indicating when the exclusivity period will expire.
Note: The FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section for approved drug products eligible for 180‑day CGT exclusivity, indicating the date the exclusivity will expire.
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