Abstract
This chapter examines an aspect of the impact of test data exclusivity through an analysis of the first Abbreviated New Drug Applications (ANDAs) to reference new chemical entities which qualified for test data exclusivity in the US between 1999 and 2009. The findings of this analysis show that test data exclusivity would appear to have an impact on the date of first generic approval for about 8% of new chemical entities approved in the US in the period studied. In addition, test data exclusivity would also appear to have had an impact on delaying patent challenges made against originator pharmaceutical products.
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Notes
- 1.
Pugatch (2006), p. 118.
- 2.
Hollis (2001), p. 14.
- 3.
Ibid.
- 4.
USA, 35 USC § 101.
- 5.
Grabowski and Vernon (2000), p. 116.
- 6.
Hemphill and Sampat (2012), p. 330.
- 7.
USA, FDCA s505(b).
- 8.
USA, 21 USC § 355.
- 9.
Ibid.
- 10.
Ibid.
- 11.
Other forms of authorisation also exist; so-called 505(b)(2) applications act as a hybrid NDA/ANDA, with the applicant relying partially on their own tests, but also partially on investigations which they did not carry out. This could be published literature, or it could be the FDA’s finding of safety or efficacy of a previously approved drug. In addition, a ‘petitioned ANDA’ refers to an ANDA for a generic that differs in dosage form, route of administration, strength or (in the case of a combination product) active ingredient submitted under 505(j)(2)(C) and approved under 505(j).
- 12.
USA, 21 USC § 314.94(a)(12)(i)(A)(1)–(4).
- 13.
USA, 21 USC § 355 (c)(3)(c).
- 14.
USA, 21 USC § 355 (c)(3)(c).
- 15.
FDA Modernization Act of 1997.
- 16.
- 17.
USA, 21 USC § 355(j)(5)(B)(iv)(II).
- 18.
Grabowski et al. (2017), p. 34.
- 19.
USA, 21 USC § 355(c)(3)(f)(iii)–(iv).
- 20.
USA, 21 USC § 360cc(a)(2).
- 21.
The ANDA for the first approved generic of one drug, Razadyne (galantamine hydrobromide), was submitted 10Â days before the end of the 48-month period from the approval of the originator NDA. This appears to have been an administrative fluke on the part of the FDA and has been recorded as being submitted 48Â months after the approval of the originator product. No other ANDAs were submitted earlier than 48Â months from the approval of the originator.
- 22.
Grabowski et al. (2017), p. 34.
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Buick, A. (2023). The Impact of Test Data Exclusivity on Abbreviated New Drug Applications in the United States. In: Intellectual Property Rights in Pharmaceutical Test Data. Springer, Cham. https://doi.org/10.1007/978-3-031-29436-5_7
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