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Results: 1 to 20 of 105

1.

The benefits from giving makers of conventional 'small molecule' drugs longer exclusivity over clinical trial data.

Goldman DP, Lakdawalla DN, Malkin JD, Romley J, Philipson T.

Health Aff (Millwood). 2011 Jan;30(1):84-90. doi: 10.1377/hlthaff.2009.1056.

PMID:
21209443
[PubMed - indexed for MEDLINE]
Free PMC Article
2.

Follow-on biologics: data exclusivity and the balance between innovation and competition.

Grabowski H.

Nat Rev Drug Discov. 2008 Jun;7(6):479-88. doi: 10.1038/nrd2532. Epub 2008 May 12.

PMID:
18469828
[PubMed - indexed for MEDLINE]
3.

Drug discovery market exclusivity after KSR: the challenge to pharmaceutical scientists and the US congress.

Wolff ME.

J Pharm Sci. 2011 Aug;100(8):3044-54. doi: 10.1002/jps.22564. Epub 2011 Apr 6.

PMID:
21472728
[PubMed - indexed for MEDLINE]
4.

Teva v. Eisai: what's the real "controversy"?

Wang GL.

Food Drug Law J. 2011;66(4):631-54, iii.

PMID:
24505831
[PubMed - indexed for MEDLINE]
5.

Policy making on data exclusivity in the European Union: from industrial interests to legal realities.

Adamini S, Maarse H, Versluis E, Light DW.

J Health Polit Policy Law. 2009 Dec;34(6):979-1010. doi: 10.1215/03616878-2009-033.

PMID:
20018988
[PubMed - indexed for MEDLINE]
6.

A trade agreement's impact on access to generic drugs.

Shaffer ER, Brenner JE.

Health Aff (Millwood). 2009 Sep-Oct;28(5):w957-68. doi: 10.1377/hlthaff.28.5.w957. Epub 2009 Aug 25.

PMID:
19706626
[PubMed - indexed for MEDLINE]
Free Article
7.

Effect of generic drug competition on the price of prescription drugs in Ontario.

Lexchin J.

CMAJ. 1993 Jan 1;148(1):35-8.

PMID:
8439888
[PubMed - indexed for MEDLINE]
Free PMC Article
8.

Prices, profits, and innovation: examining criticisms of new psychotropic drugs' value.

Huskamp HA.

Health Aff (Millwood). 2006 May-Jun;25(3):635-46.

PMID:
16684726
[PubMed - indexed for MEDLINE]
Free PMC Article
9.

Generic entry, reformulations and promotion of SSRIs in the US.

Huskamp HA, Donohue JM, Koss C, Berndt ER, Frank RG.

Pharmacoeconomics. 2008;26(7):603-16.

PMID:
18563951
[PubMed - indexed for MEDLINE]
Free PMC Article
10.

Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug applications; clarification--FDA. Clarification.

[No authors listed]

Fed Regist. 1997 Nov 28;62(229):63268-9.

PMID:
10177950
[PubMed - indexed for MEDLINE]
11.

Data exclusivity for biologics.

Grabowski H, Long G, Mortimer R.

Nat Rev Drug Discov. 2011 Jan;10(1):15-6. doi: 10.1038/nrd3277. No abstract available. Erratum in: Nat Rev Drug Discov. 2011 Jun;10(6):471.

PMID:
21193860
[PubMed - indexed for MEDLINE]
12.

The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.

Panattoni LE.

J Health Econ. 2011 Jan;30(1):126-45. doi: 10.1016/j.jhealeco.2010.09.004. Epub 2010 Oct 8.

PMID:
21074873
[PubMed - indexed for MEDLINE]
13.
14.

The Eleventh Circuit holds that agreements in which pharmaceutical companies pay generic companies not to compete may be valid.

Garrigues A.

J Law Med Ethics. 2004 Spring;32(1):181-4. No abstract available.

PMID:
15152443
[PubMed - indexed for MEDLINE]
15.

Are we living in the end of the blockbuster drug era?

Debnath B, Al-Mawsawi LQ, Neamati N.

Drug News Perspect. 2010 Dec;23(10):670-84. doi: 10.1358/dnp.2010.23.10.1506088. Review.

PMID:
21180653
[PubMed - indexed for MEDLINE]
16.

Drug marketing exclusivity under United States and European Union law.

Junod V.

Food Drug Law J. 2004;59(4):479-518. No abstract available.

PMID:
15875347
[PubMed - indexed for MEDLINE]
17.

The economics of pediatric formulation development for off-patent drugs.

Milne CP, Bruss JB.

Clin Ther. 2008 Nov;30(11):2133-45. doi: 10.1016/j.clinthera.2008.11.019. Review.

PMID:
19108801
[PubMed - indexed for MEDLINE]
18.

Economic advantage of pharmacogenomics - clinical trials with genetic information.

Ohashi W, Mizushima H, Tanaka H.

Stud Health Technol Inform. 2008;136:585-90.

PMID:
18487794
[PubMed - indexed for MEDLINE]
19.

Economics and structure of the generic pharmaceutical industry.

Kirking DM, Ascione FJ, Gaither CA, Welage LS.

J Am Pharm Assoc (Wash). 2001 Jul-Aug;41(4):578-84. Review.

PMID:
11486984
[PubMed - indexed for MEDLINE]
20.

Incentives for orphan drug research and development in the United States.

Seoane-Vazquez E, Rodriguez-Monguio R, Szeinbach SL, Visaria J.

Orphanet J Rare Dis. 2008 Dec 16;3:33. doi: 10.1186/1750-1172-3-33.

PMID:
19087348
[PubMed - indexed for MEDLINE]
Free PMC Article
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