Regulatory aspects for competitive Generic Therapies in USA
The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1)
FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will
- Explain the process and criteria to request and designate a drug as a CGT.
- Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT.
- Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)
2. Competitive Generic Therapies, Guidance for Industry [Internet]. USFDA; 2020 [cited 2021 Apr 01]. Available from: https://www.fda.gov/media/136063/download
3. Federal Food, Drug, And Cosmetic Act, Section 506H(e)(2)(A) [Internet]. Federal Food, Drug, And Cosmetic Act; [updated 2021 Jan 05; cited 2021 Apr 02]. Available from: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf
4. Federal Food and Drug Reauthorization Act, Section 803 [Internet]. Federal Food and Drug Reauthorization Act; 2017 Aug 18 [cited 2021 Apr 01]. Available from: https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf
5. Controlled Correspondence Related to Generic Drug Development Guidance for Industry, Guidance for Industry [Internet]. USFDA; 2020 [cited 2021 Apr 07]. Available from: https://www.fda.gov/media/109232/download
6. ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence), Guidance for Industry [Internet]. USFDA; 2017 [cited 2021 Apr 03]. Available from: https://www.fda.gov/media/105794/download
7. Federal Food and Drug Reauthorization Act, Section 803 [Internet]. Federal Food and Drug Reauthorization Act. 2017 Aug 18 [cited 2021 Apr 02]. Available from: https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf
8. Alan Minsk, Seth Ray, Competitive Generic Therapies: FDA Issues Final Guidance [Internet]. Jdsupra; 2020 Jun 03 [cited 2021 Apr 01]. Available from: https://www.jdsupra.com/legalnews/competitive-generic-therapies-fda-28268/
9. Thomas Sullivan, FDA Publishes Final Guidance on Competitive Generic Therapies, Policy and Medicine, Rockpointe Publications [Internet] policymed; 2020 [updated 2020 May 06, cited 2021 April 06]. Available from: https://www.policymed.com/2020/05/fda-publishes-final-guidance-on-competitive-generic-therapies.html
10. Sailesh K. Patel, Thomas A. Rammer II, Competitive Generic Therapy Exclusivity Offers Benefits, Schiff Hardin [Internet]. Schiffhardin; 2019 Apr 25 [cited 2021 Apr 06]. Available from: https://www.schiffhardin.com/insights/publications/2019/competitive-generic-therapy-exclusivity-offers-benefits
11. Prasad V, Kale P. Complex Generics: Opportunities & Challenges. Int J Drug Reg Affairs [Internet]. 2018 Feb 13 [cited 2021 Jun 15];4(3):1-10. Available from: http://ijdra.com/index.php/journal/article/view/184
12. M SK, Katamreddy JD, P JR. A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines. Int J Drug Reg Affairs [Internet]. 2018 Sep 15 [cited 2021 Jun 15];6(3):5-12. Available from: http://ijdra.com/index.php/journal/article/view/260
13. Shah S, Badjatya JK. Preliminary requirement for filing application in US. Int J Drug Reg Affairs [Internet]. 2018 Dec 20 [cited 2021 Jun 15];6(4):1-. Available from: http://ijdra.com/index.php/journal/article/view/276
14. Kashyap P, Duggal E, Budhwar P, Badjatya JK. MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES. Int J Drug Reg Affairs [Internet]. 2013 Oct 31 [cited 2021 Jun 15];1(3):1-6. Available from: http://ijdra.com/index.php/journal/article/view/5
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