Polymorphisms and patent, market, and legal battles: Cefdinir case study

Organic Process Research and Development

Volumn 11, Issue 1, 2007, Pages 64-72

  Cabri, Walter ^a,b   Ghetti, Paolo ^a   Pozzi, Giovanni ^a   Alpegiani, Marco ^a  

^a Antibioticos SpA   (Italy)

^b R and D   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33847721941     PISSN: 10836160     EISSN: None     Source Type: Journal    
DOI: 10.1021/op0601060     Document Type: Review

References (36)

1. Inamoto, Y.; Chiba, T.; Kamimura, T.; Takaya, T. J. Antibiot. 1988, 41, 828.
2. NDA 50-749. [Fujisawa (Astellas) Parke Davis (Abbott)] approved by the FDA 1999. See www.fda.gov.
3. IMS data 2004.
4. (a) Mine, Y.; Kamimura, T.; Watanabe, Y.; Tawara, S.; Matsumoto, Y.; Shibayama, F.; Kikuchi, H.; Takaya, T. J. Antibiot. 1988, 41, 1873.
5. (b) Mine, Y.; Yokota, Y.; Wakai, Y.; Kamimura, T.; Tawara, S.; Shibayama, F.; Kikuchi, H. J. Antibiot. 1988, 41, 1888.
6. (c) Sakamoto, H.; Hirose, T.; Nakamoto, S.; Hatano, K.; Shibayama, F.; Kikuchi, H.; Mine, Y. J. Antibiot. 1988, 41, 1896.
7. (d) Mine, Y.; Kamimura, T.; Sakamoto, H.; Tawara, S.; Hatano, K.; Watanabe, Y.; Kuwahara, S. Chemotherapy 1989, 37, 122.
8. (e) Shimada, K.; Shishido, R.; Kakuno, M. Chemotherapy 1989, 37, 208.
9. (a) Special feature section devoted to crystallization and polymorphism: Org. Process Res. Dev. 2000, 6, 957-1027.
10. (b) Bernstein, J. Polymorphism in Molecular Crystal; Oxford University Press: New York, 2002.
11. (c) Byrn, S. R.; Pfeiffer, R. R.; Stowell, J. G. Solid State Chemistry of Drugs; SSCI: West Lafayette, 1999.
12. In Europe: (a) Takaya, T.; Takasugi, H.;Masugi, T.;Yamanaka, H.; Kawabata, K. EP105459 (filed September 1983, priorities UK 8323034 filed 26 August 1983, and U.S. Patent 8,323,034 filed 30 September 1982). In the United States:
13. (b) Takaya, T.; Shirai, F.; Nakamura, H.; Inaba, Y. U.S. Patent 4,559.334 (filed 20 October 1983).
14. In Europe: Takaya, T.; Shirai, F.; Nakamura, H.; Inaba, Y. EP304019 (filed 17 August 1988. priority JP206199 19 August 1987)). In the United States: U.S. Patent 4,935,507 (filed 8 August 1988) extended by the Waxman Hatch provision up to 4 December 2011.
15. Italy: Antibioticos, ACS Dobfar, Pharmabios and Ribbon. Austria and Germany: Sandoz.
16. Manca, A.; Sala, B.; Monguzzi, R. US2003/0204082 (filed 3 April 2003. priority Italy MI2002A 000913 filed 29 April 2002).
17. Kumar, Y.; Prasad, M.; Prasad, A.; WO2004/104010 (filed 20 May 2004, priority IN2003DE0000711 filed 20 May 2003).
18. Deshpande, P. B.; Khadangale, B. P.; Ramasubbu, C. WO2004/046154 (filed 10 November 2003, priorities IN848/MAS/2002 and IN152/mas/2003 filed respectively 15 November 2002 and 26 February 2003).
19. Chandrasekaran, R.; Senthilkumar, K.; Murugan, S.; Sivaiah Sangaraju, V. R.; Reddy, G. O. WO2005/090360 (filed 15 March 2005, priority IN247/ MAS/2004 filed 19 March 2004).
20. Dandala, S.; Sivakumaran, S. US2005/0137182 (filed 29 October 2004, priority IN440/MAS/2003 filed 2 June 2003).
21. Duerst, R. W.; Law, D.; Lou, X. US2005/0059818 (priority US2003000661148 filed 12 September 2003).
22. Duerst, R. W.; Law, D.; Lou, X. US2005/0113355 (filed 14 September 2004 divisional of 14).
23. Law, D.; Henry, R. F.; Lou, X. WO2005/090361 (filed 7 March 2005, priority United States 16 March 2004).
24. Server, N. A.; Law, D. WO2005/100368 (filed 11 April 2005, priority United States 9 April 2004).
25. Singh, G. P.; Sen, H.; Srivastava, D.; Godbole, H. M.; Singh, G. P.; Mahajan, P. R.; Rananaware, U. B.; Nehate, S. P.; Wagh, S. C. US2005/0245738 (priority U.S. Patent 10/838431 filed 3 May 2004).
26. Daemon, O.; Hartmann, K.; Ranenburger, J. US2006/0122165 (filed 5 December 2005, priority GB0426537.1 filed 7 Dec 2004).
27. (a) Cephalexin isomorphic solvates: Stephenson, G. A.; Groleau, E. G.; Kleeman, R. L.; Xu, W.; Rigsbee, D. R. J. Pharm. Sci. 1998, 87, 536.
28. (b) Topotecan isomorphic solvates : Vogt, F. G.; Dell'Orco, P. C.; Diederich, A. M.; Su, Q.; Wood, J. L.; Zuber, G. E.; Katrincic, L. M.; Mueller, R. L.; Busby, D. J.; DeBrosse, C. W. J. Pharm. Biomed. Anal. 2006, 40, 1080 and references therein.
29. Sturm, H.; Wolf, S.; Ludescher, J. U.S. Patent 6,350,869 (filed 27 September 1999, priority AT57097 filed 4 April 1997).
30. For IP statistics see: http://www.wipo.int/ipstats/en/.
31. Q3C(R3): Impurities: Guideline for Residual Solvents. EU: Adopted by CPMP, September 97, issued as CPMP/ICH/283/95 MHLW: Adopted March 1998, PMSB/ELD Notification No.307 FDA: Published in the Federal Register 1997, 62(No. 247, December 24), 67377.
32. (a) Form I by Pfizer; Sabatino, P.; Riva di Sanseverino, L.; Tonani, R. Farmaco 1995, 50, 175.
33. (b) Form II by Pfizer; Tomasi, A.; Magenes, S.; Ramella, G.; Ungari, M.; Pandolfi, M. U.S. Patent 6,673,806 (filed 16 January 2003).
34. (c) Form VII by Pfizer; Candiani, I.; Budelli, R.; Pandolfi, M.(Ungari, M. U.S. Patent 6,680,327 (filed 18 September 2002).
35. (d) Amorphous form and solvates VIII, IX, XI, XII, XIV, XV, XVI, XVII, and XVIII by Ivax; Cvak, L.; Bednar, R.; Sobotik, R.; Jegorov, A. WO04101510 (filed 27 January 2004).
36. (e) Amorphous form and solvate A by Finetech; Gutman, A.; Tishin, B.; Vilenski, A.; Agazade, A.; Pertzikov, B.; Nisnevich, G. WO04094368A (filed 20 April 2004).