Longer Patents for Increased Generic Competition in the US
Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost durin...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Grabowski, Henry [verfasserIn] Vernon, John [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
1996 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: PharmacoEconomics - Berlin [u.a.] : Springer, 1992, 10(1996), Suppl 2 vom: Dez., Seite 110-123 |
|---|---|
| Übergeordnetes Werk: |
volume:10 ; year:1996 ; number:Suppl 2 ; month:12 ; pages:110-123 |
| Links: |
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| DOI / URN: |
10.2165/00019053-199600102-00017 |
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| 520 | |a Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. | ||
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10.2165/00019053-199600102-00017 doi (DE-627)SPR033323801 (SPR)00019053-199600102-00017-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Grabowski, Henry verfasserin aut Longer Patents for Increased Generic Competition in the US 1996 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. Generic Drug (dpeaa)DE-He213 Orphan Drug (dpeaa)DE-He213 Wholesale Price (dpeaa)DE-He213 Generic Entry (dpeaa)DE-He213 Generic Competition (dpeaa)DE-He213 Vernon, John verfasserin aut Enthalten in PharmacoEconomics Berlin [u.a.] : Springer, 1992 10(1996), Suppl 2 vom: Dez., Seite 110-123 (DE-627)327645717 (DE-600)2043876-X 1179-2027 nnns volume:10 year:1996 number:Suppl 2 month:12 pages:110-123 https://dx.doi.org/10.2165/00019053-199600102-00017 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 10 1996 Suppl 2 12 110-123 |
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10.2165/00019053-199600102-00017 doi (DE-627)SPR033323801 (SPR)00019053-199600102-00017-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Grabowski, Henry verfasserin aut Longer Patents for Increased Generic Competition in the US 1996 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. Generic Drug (dpeaa)DE-He213 Orphan Drug (dpeaa)DE-He213 Wholesale Price (dpeaa)DE-He213 Generic Entry (dpeaa)DE-He213 Generic Competition (dpeaa)DE-He213 Vernon, John verfasserin aut Enthalten in PharmacoEconomics Berlin [u.a.] : Springer, 1992 10(1996), Suppl 2 vom: Dez., Seite 110-123 (DE-627)327645717 (DE-600)2043876-X 1179-2027 nnns volume:10 year:1996 number:Suppl 2 month:12 pages:110-123 https://dx.doi.org/10.2165/00019053-199600102-00017 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 10 1996 Suppl 2 12 110-123 |
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10.2165/00019053-199600102-00017 doi (DE-627)SPR033323801 (SPR)00019053-199600102-00017-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Grabowski, Henry verfasserin aut Longer Patents for Increased Generic Competition in the US 1996 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. Generic Drug (dpeaa)DE-He213 Orphan Drug (dpeaa)DE-He213 Wholesale Price (dpeaa)DE-He213 Generic Entry (dpeaa)DE-He213 Generic Competition (dpeaa)DE-He213 Vernon, John verfasserin aut Enthalten in PharmacoEconomics Berlin [u.a.] : Springer, 1992 10(1996), Suppl 2 vom: Dez., Seite 110-123 (DE-627)327645717 (DE-600)2043876-X 1179-2027 nnns volume:10 year:1996 number:Suppl 2 month:12 pages:110-123 https://dx.doi.org/10.2165/00019053-199600102-00017 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 10 1996 Suppl 2 12 110-123 |
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10.2165/00019053-199600102-00017 doi (DE-627)SPR033323801 (SPR)00019053-199600102-00017-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Grabowski, Henry verfasserin aut Longer Patents for Increased Generic Competition in the US 1996 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. Generic Drug (dpeaa)DE-He213 Orphan Drug (dpeaa)DE-He213 Wholesale Price (dpeaa)DE-He213 Generic Entry (dpeaa)DE-He213 Generic Competition (dpeaa)DE-He213 Vernon, John verfasserin aut Enthalten in PharmacoEconomics Berlin [u.a.] : Springer, 1992 10(1996), Suppl 2 vom: Dez., Seite 110-123 (DE-627)327645717 (DE-600)2043876-X 1179-2027 nnns volume:10 year:1996 number:Suppl 2 month:12 pages:110-123 https://dx.doi.org/10.2165/00019053-199600102-00017 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 10 1996 Suppl 2 12 110-123 |
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10.2165/00019053-199600102-00017 doi (DE-627)SPR033323801 (SPR)00019053-199600102-00017-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Grabowski, Henry verfasserin aut Longer Patents for Increased Generic Competition in the US 1996 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. Generic Drug (dpeaa)DE-He213 Orphan Drug (dpeaa)DE-He213 Wholesale Price (dpeaa)DE-He213 Generic Entry (dpeaa)DE-He213 Generic Competition (dpeaa)DE-He213 Vernon, John verfasserin aut Enthalten in PharmacoEconomics Berlin [u.a.] : Springer, 1992 10(1996), Suppl 2 vom: Dez., Seite 110-123 (DE-627)327645717 (DE-600)2043876-X 1179-2027 nnns volume:10 year:1996 number:Suppl 2 month:12 pages:110-123 https://dx.doi.org/10.2165/00019053-199600102-00017 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 10 1996 Suppl 2 12 110-123 |
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Longer Patents for Increased Generic Competition in the US |
| abstract |
Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. |
| abstractGer |
Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. |
| abstract_unstemmed |
Summary The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act’s existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. |
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| container_issue |
Suppl 2 |
| title_short |
Longer Patents for Increased Generic Competition in the US |
| url |
https://dx.doi.org/10.2165/00019053-199600102-00017 |
| remote_bool |
true |
| author2 |
Vernon, John |
| author2Str |
Vernon, John |
| ppnlink |
327645717 |
| mediatype_str_mv |
c |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| doi_str |
10.2165/00019053-199600102-00017 |
| up_date |
2024-07-03T17:56:48.060Z |
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1803581556588019712 |
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7.3990374 |