The Competitive Generic Therapy (CGT)
Raghunandhan Painoori, Director Regulatory Affairs & Pharmacovigilance, Odin Pharmaceuticals, LLC.
Dr. Naveen Chella, Assistant Professor, NIPER
The Competitive Generic Therapy (CGT) Act, introduced by the US FDA in 2017 under the Generic Drug User Fee Act (GDUFA), aims to lower drug costs by promoting generics where competition is limited. It offers incentives like market exclusivity, priority reviews, and mid-cycle meetings to speed up approvals. This policy review highlights CGT’s effectiveness, the number of approvals granted under it, and its role in improving patient access to safe, affordable generic medications amidst insufficient market competition.
Introduction:
Generic medications are critical in the healthcare sector due to their affordability and accessibility to the public, while maintaining comparable quality, efficacy, and safety to that of branded products. Generic medications research and development, followed by commercialisation, also fosters competition and innovation within the pharmaceutical industry. The United States Food and Drug Administration (US FDA) defines a generic medication as “a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use” (1).
Regulatory agencies globally ensure that generic drugs exhibit therapeutic equivalence to innovative products. The generic drug industry has experienced significant growth since the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman amendments (2). Generic Drug manufacturers are required to submit Abbreviated New Drug Application (ANDA) applications to the US FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to market their generic products in the United States. Under the Hatch-Waxman amendments, a generic manufacturer may apply with a Paragraph IV certification, and there are provisions under which a 180-day exclusivity can be secured upon meeting the legal obligations (first ANDA with Paragraph IV certification) and following a successful evaluation of the ANDA for quality, safety and compliance by the USFDA. An ANDA applicant can submit a Paragraph IV patent certification as per 21 CFR 314.94(a)(12)(i)(A)(4)(i) for each patent listed in the orange book certifying that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the ANDA will be submitted (3). In general, this exclusivity period may commence either from the first approved generic product marketing start date or from a court ruling that the innovator patent is invalid or not infringed, whichever occurs first. The amendment has facilitated increased competitiveness, potentially reducing the costs and enhancing affordability for the patients (2).
Competitive Generic Therapy: To enhance competition among generic drugs, particularly in scenarios where there are a few generic options due to complexity or limited market appeal, in the year 2017, the United States Congress instituted a mechanism referred to as competitive generic therapy (CGT). Section 803 of the FDA Reauthorization Act (FDARA) modified the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding Section 506H, which established a new procedure known as CGT to accelerate the development, review and approval of certain medications facing inadequate generic competition. This pathway was designed to provide advantages to both the general public and the pharmaceutical industry. Patients benefit from the increased access to medications with limited competition at lower prices, while the pharmaceutical industry receives incentives like exclusivity and expedited approvals (4,5).
In accordance with the FDARA, drugs granted the CGT designation are entitled to a 180-day exclusivity period, distinct from the 180-day exclusivity associated with patent challenges. This new exclusivity applies to drugs that are not protected by patents or other exclusivities and that face insufficient competition. The US FDA prepared draft guidance on CGT in February 2019, which was subsequently revised, and the final guidance was published in October 2022 following feedback from various stakeholders (6).
CGT designation to drug: According to the USFDA guidance, a drug may be designated as a CGT post determining that the drug has inadequate generic competition. A drug is considered under inadequate generic competition when there is no more than one approved drug listed in the active section of the Orange Book for that specific strength at the time of the CGT designation request.
Submission timing and requirements: To obtain the CGT designation, applicants must submit their request either concurrently with or prior to the submission of the ANDA. Any request submitted after the ANDA will be rejected. The request for designation under the 506H of FD&C Act must include the preassigned ANDA number, detailed information about the drug (including application number, name, and strength), and evidence demonstrating the drug's eligibility due to inadequate generic competition (7).
Process post submission: The USFDA conducts a review of the submitted application to assess the criteria for inadequate generic competition, as determined by the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) listing and the supporting data provided. The USFDA aims to decide within 60 calendar days following the submission of the application.
The evaluation process for CGT CGT-designated drug can be delayed by several factors, such as the complexity of the application, which may involve intricate formulations and release mechanisms requiring in-depth scientific analysis and expert discussion, potentially extending the evaluation timeline. Additionally, scientific or regulatory questions may arise for medicinal products lacking established guidelines or requiring product-specific evaluations, necessitating careful consideration and possibly prolonging the review process. An unexpired patent or exclusivity listed in the Orange Book associated with the drug in question can also delay the process, as the US FDA generally does not consider that application for expedited review. The timeline can also be influenced by several factors, such as the accuracy of submitted documents, the volume of applications at the USFDA at a given time, and staff workload, among others. In addition, an incomplete or misleading document/s may need correction and resubmission, and a sudden increase in applications can exacerbate workload challenges.
There are several strategies listed and discussed in the following sections that could lead to accelerated and timely evaluation of the CGT application of the ANDA. Several factors contribute to the acceleration and timely evaluations.
Strategies to accelerate ANDA under the CGT application
Pre-ANDA Meetings: The Pre-ANDA program is designed by the USFDA for developing a complete submission to facilitate the timely approval of generic drug products. Engaging with the USFDA before ANDA submission through product development meetings or pre-submission meetings to discuss scientific matters or to present novel or unique data in the ANDA pertaining to formulations or critical studies helps the ANDA applicant to gain USFDA insights and suggestions. This is a good strategy to prevent unnecessary delays in approval caused by critical issues identified during the ANDA review (4).
Scientific Simplicity: Formulations that are developed by applications of scientific principles by use of quality by design concepts become straightforward and comply with all regulatory guidelines, avoid uncertainties related to the regulatory framework expedite the approval process (8).
High Public Health Impact: Products that address unmet medical needs or benefit a large population of patients could receive expedited clearance from the US FDA.
Expired Patents/Exclusivities for branded drug products: The submission of accurate documentation for drug products without exclusivity or patent issues facilitates smooth progression through the evaluation steps, ensuring timely clearance from the US FDA.
Mid-Cycle Review Meetings: During the ANDA review, the USFDA also provides an opportunity to request mid-cycle review meetings during the first assessment cycle. Applicants can also request enhanced mid-cycle review meetings for complex products. This can be communicated through an ANDA acknowledgement letter or a CGT designation letter.
CGT Designated Drug Exclusivity: Following the designation of a drug as a CGT, the review process for an ANDA can be expedited. Multiple applications may be approved for a single drug under the CGT designation. However, the drug is eligible for exclusivity under section 505(j) (5)(B)(v) if it is solely the first approved application which fulfills all regulatory requirements like approved on first day, not eligible for 180 days exclusivity under patent challenge (505(j)(5)(B)(iv)), and the drug versions have forfeited eligibility for 180-day patent challenge exclusivity as well (3). Different dosage forms of the same drug may be considered separately for CGT applications. An ANDA product can exist without a CGT designation before the first CGT designation. The first approved drug product with a CGT designation will receive 180 days of exclusivity. The CGT exclusivity is triggered by informing the US FDA about the first commercial marketing date of the CGT-designated drug product by any first approved applicant. The post-triggering of the 180 days runs uninterrupted. It is noteworthy to mention that the first approved applicant will forfeiture the 180 days CGT exclusivity if the applicant fails to market the CGT product within 75 days after the first approved application's approval date.
The designation of CGT offers several advantages to applicants ANDAs.
Incentives for CGT Designated Drug
Priority for review meetings and expedited product development: Applicants are granted access to review meetings with the US FDA, which assist in identifying obstacles during the approval process and provide an opportunity to understand the USFDA's perspective on the product. This may facilitate the resolution of scientific and regulatory concerns at an accelerated pace, thereby expediting the process by reducing the number of ANDA review cycles.
Eligibility for 180-day exclusivity: The first applicant who is granted a CGT designation is awarded 180 days of marketing exclusivity as specified in section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity allows the applicant to create a foothold in the market for their product with limited competition, resulting in financial benefits while addressing public health needs. This period of marketing exclusivity is only valid if the applicant satisfies all outlined criteria, including the absence of any patents or exclusivities connected to the drug product in their application and the obligation to begin marketing the approved drug product within 75 days of the first approved applicant’s ANDA.
The Competitive Generic Therapy (CGT) designation provides applicants with both regulatory and commercial incentives, promoting competition and improving patient access to cost-effective medicines. The Office of Generic Drugs provides a comprehensive list of all drugs approved under ANDA that have received CGT designation. This listing acts as a valuable resource for pharmaceutical industries and other stakeholders seeking information and insights. It is accessible on the USFDA website (9) and is updated as new ANDA approvals occur. The list contains comprehensive details about each drug product, including Reference Listed Drug (RLD) name and its New Drug Application (NDA) number, ANDA number, ANDA applicant, active ingredient name, dosage form, strength, approval date, CGT eligibility, CGT forfeiture, and the date when commercial marketing first began. According to the recent data available as of August 02 2025, a total of 147 ANDAs have been received CGT approval and exclusivity from the US FDA. This number is derived from the USFDA’s regularly updated public list of CGT-approved ANDAs, specifically filtered for entries with CGT eligibility marked as 'Yes', CGT Forfeiture ‘No’ and date of first commercial marketing (9).
Conclusion:
The CGT designation made a huge difference in the generic industry landscape by accelerating the development and approval of generic medications that are under inadequate competition. The generic industry was incentivised with multiple meeting options, accelerated approval by not compromising on the safety and effectiveness and subsequently gaining 180 days of exclusivity. This helped to bring affordable generic medications to the patients faster, especially in critical therapeutic areas (older injectable and ophthalmic products) where choices are limited. The full potential of CGT is yet to be realised, particularly in the complex generics space. With the expanded scope in regulatory guidance, streamlined review pathways, the CGT has the potential to become even more impactful in the future, helping patients with life saving medications that are affordable and accessible.
References
- US FDA. Generic Drugs: Questions & Answers. 2021. p. 1–7. https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers. Accessed on 26th July 2025.
- US FDA. 40th Anniversary of the Generic Drug Approval Pathway. 2024. https://www.fda.gov/drugs/cder-conversations/40th-anniversary-generic-drug-approval-pathway. Accessed on 26th July, 2025.
- 21 CFR 314.94: Content and Format of an ANDA eCFR :: 21 CFR 314.94 -- Content and format of an ANDA. Accessed on August 2nd August 2025.
- US FDA. Competitive Generic Therapies. 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies. Accessed on 26th July, 2025.
- Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clin Pharmacol Ther. 2019 Feb 10;105(2):329–37.
- USFDA, CDER. Guidance for Industry: Competitive Generic Therapies [Internet]. 2022. Available from: https://www.regulations.gov/docket/FDA-2019-D-0065/comments. Accessed on 27th July 2025.
- Chahal HS, Fowler AC, Patel R, Shimer M. Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity. JAMA. 2021 Nov 9;326(18):1863.
- Patricia Van Arnum. FDA Issues Guidance for Competitive Generic Therapies. DCAT Value chain insights. 2020 Mar 20. https://www.dcatvci.org/features/fda-issues-guidance-for-competitive-generic-therapies/. Accessed on 26th July 2025.
- Competitive Generic Therapy Approvals https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvalsAccessed on August 02, 2025.
Raghunandhan Painoori is a Regulatory Affairs Specialist with extensive expertise in managing the submission and approval process for Abbreviated New Drug Applications (ANDAs) with the USFDA. His experience includes several first-to-file submissions, Competitive Generic Therapy (CGT) designations, and complex generics. With over 20 years in major pharmaceutical companies, he is currently the Director of Regulatory Affairs at Odin Pharmaceuticals, LLC, focusing on advancing regulatory strategies for complex generics.
Dr. Naveen Chella is an Assistant Professor of Pharmaceutical Technology (Formulations) at NIPER Guwahati, India. His research centers on the development of drug delivery systems for BCS Class II and IV drugs. He has authored 40 peer-reviewed publications and 11 book chapters. Dr. Chella has filed seven Indian patents, two of which have been granted.
