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)

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Therapeutic Equivalence and the Generic Competition Paradox

The B E Journal of Economic Analysis & Policy ◽

10.1515/1935-1682.3234 ◽

2012 ◽

Vol 12 (1) ◽

Cited By ~ 2

Author(s):

Munirul Haque Nabin ◽

Vijay Mohan ◽

Aaron Nicholas ◽

Pasquale M. Sgro

Keyword(s):

Simple Model ◽

Generic Drug ◽

Generic Drugs ◽

Large Body ◽

Medical Community ◽

Therapeutic Equivalence ◽

Generic Competition ◽

Branded Drug ◽

Fda Approval ◽

Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Journal of Biosciences and Medicines ◽

10.4236/jbm.2021.910003 ◽

2021 ◽

Vol 09 (10) ◽

pp. 23-39

Author(s):

Md. Imtiaz Hasan ◽

Shahnaz Akter Shimu ◽

Akhi Akther ◽

Ishrat Jahan ◽

Md. Hamiduzzaman ◽

...

Keyword(s):

Generic Drug ◽

Drug Products ◽

Regulatory Aspects ◽

Pharmaceutical Industries

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Regulatory Aspects of Post-Approval Safety Reporting for Generic Drug Products in the US

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x03666160928155231 ◽

2016 ◽

Vol 3 (3) ◽

pp. 142-150

Author(s):

Priti J. Mehta ◽

Chandni K. Doshi

Keyword(s):

Generic Drug ◽

Drug Products ◽

Safety Reporting ◽

Regulatory Aspects ◽

The Us

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Generic Drug Policy and Suboxone to Treat Opioid Use Disorder

The Journal of Law Medicine & Ethics ◽

10.1177/1073110519898042 ◽

2019 ◽

Vol 47 (S4) ◽

pp. 43-53 ◽

Cited By ~ 1

Author(s):

Rebecca L. Haffajee ◽

Richard G. Frank

Keyword(s):

Generic Drug ◽

Risk Evaluation ◽

Opioid Use Disorder ◽

Evidence Based ◽

Brand Name ◽

Opioid Use ◽

Generic Competition ◽

Grant Programs ◽

Disorder Treatment ◽

Competitive Activities

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.

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The Anticompetitive Effects of Common Ownership: The Case of Paragraph IV Generic Entry

AEA Papers and Proceedings ◽

10.1257/pandp.20201029 ◽

2020 ◽

Vol 110 ◽

pp. 569-572 ◽

Cited By ~ 2

Author(s):

Jin Xie ◽

Joseph Gerakos

Keyword(s):

Generic Drug ◽

Pharmaceutical Companies ◽

Generic Manufacturer ◽

Brand Name ◽

Generic Entry ◽

Common Ownership ◽

Settlement Agreement

Brand-name pharmaceutical companies often file lawsuits against generic drug manufacturers that challenge the monopoly status of patent-protected drugs. Institutional horizontal shareholdings, measured by the generic shareholders' ownership in the brand-name company relative to their ownership in the generic manufacturer, are significantly positively associated with the likelihood that the two parties enter into a settlement agreement in which the brand pays the generic manufacturer to stay out of the market.

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A Generic Drug Primer: Regulatory Aspects and Scientific Concepts

Military Medicine ◽

10.1093/milmed/163.4.193 ◽

1998 ◽

Vol 163 (4) ◽

pp. 193-197 ◽

Cited By ~ 2

Author(s):

James D. Henderson ◽

George L. White

Keyword(s):

Generic Drug ◽

Scientific Concepts ◽

Regulatory Aspects

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Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

Health SA Gesondheid ◽

10.4102/hsag.v21i0.935 ◽

2016 ◽

Vol 21 ◽

pp. 60-66 ◽

Cited By ~ 2

Author(s):

Varsha Bangalee ◽

Fatima Suleman

Keyword(s):

South Africa ◽

South African ◽

Generic Drug ◽

Generic Drugs ◽

Interquartile Range ◽

Price Ratio ◽

Generic Competition ◽

International Reference ◽

Drug Prices ◽

The Relationship

Background: This research focuses on pharmaceutical competition in South Africa where concurrent pricing legislation is being implemented without monitoring the consequences on generic drug competition and usage.Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices.Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition).Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46) and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47).Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

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