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Information, Expiry, & Status of FDA Orange Book Exclusivities covering 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine

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Product

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine
U.S. EXCLUSIVITIES

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 17 USDMF, 2 JDMF, 14 EU WC, 6 KDMF, 19 NDC API, 16 Listed Suppliers, $ API Reference Price

31 API Suppliers
17 USDMF
2 JDMF
14 EU WC
6 KDMF
19 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

171 FDF Dossiers, 52 FDA Orange Book, 32 Europe, 24 Canada, 52 South Africa, 11 Listed Dossiers

171 FDF Dossiers
52 FDA Orange Book
32 Europe
24 Canada
52 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG, TABLET;ORAL - 150MG;150MG;200MG;300MG, TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE, TABLET;ORAL - 120MG;EQ 15MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE, TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE, TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE, CAPSULE;ORAL - 200MG, TABLET;ORAL - 100MG;150MG, TABLET;ORAL - 133MG;200MG, TABLET;ORAL - 167MG;250MG, TABLET;ORAL - 200MG;300MG

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG
TABLET;ORAL - 150MG;150MG;200MG;300MG
TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE
TABLET;ORAL - 120MG;EQ 15MG BASE
TABLET;ORAL - 200MG;EQ 25MG BASE
TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE
TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE
TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE
CAPSULE;ORAL - 200MG
TABLET;ORAL - 100MG;150MG
TABLET;ORAL - 133MG;200MG
TABLET;ORAL - 167MG;250MG
TABLET;ORAL - 200MG;300MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 8 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 16 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 33 Controlled & Modified Release, 31 Direct Compression, 24 Thickeners and Stabilizers, 22 Granulation, 22 Disintegrants & Superdisintegrants, 18 Solubilizers, 16 Topical, 16 Lubricants & Glidants, 14 Co-Processed Excipients, 12 Parenteral, 12 Film Formers & Plasticizers, 11 Taste Masking, 9 Empty Capsules, 7 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 3 Rheology Modifiers

69 Fillers, Diluents & Binders
53 Coating Systems & Additives
33 Controlled & Modified Release
31 Direct Compression
24 Thickeners and Stabilizers
22 Granulation
22 Disintegrants & Superdisintegrants
18 Solubilizers
16 Topical
16 Lubricants & Glidants
14 Co-Processed Excipients
12 Parenteral
12 Film Formers & Plasticizers
11 Taste Masking
9 Empty Capsules
7 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
3 Surfactant & Foaming Agents
3 Rheology Modifiers

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 3 STOCK RECAP #PipelineProspector, 191 NEWS #PharmaBuzz

6 DATA COMPILATION #PharmaFlow
3 STOCK RECAP #PipelineProspector
191 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 29 Finished Drug Prices, 55 Annual Reports

5 US Medicaid Prescriptions
29 Finished Drug Prices
55 Annual Reports

MARKET PLACE

8 APIs, 9 FDF Dossiers

8 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

111 US Patents, 11 US Exclusivities, 2 Health Canada Patents

111 US Patents
11 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 4 Others

3 USP
4 Others

$ API Ref.Price (USD/KG) : 396 Xls

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11 All

01 12024-02-24

02 22024-09-28

03 12026-06-18

04 22027-02-23

05 12027-04-24

06 12028-10-07

07 12029-01-07

08 22031-02-23

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01 2I-942

02 1M-305

03 1M-82

04 1ODE-256

05 1ODE-284

06 1ODE-285

07 1ODE-378

08 1ODE-457

09 2ODE-468

US Patents
US Exclusivities
Health Canada Patents

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Exclusivity Code

I-942

Exclusivity Expiration Date

2027-02-23

Application Number

210251

Product Number

2

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Exclusivity Code : I-942

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Exclusivity Code

ODE-378

Exclusivity Expiration Date

2028-10-07

Application Number

210251

Product Number

2

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Exclusivity Code : ODE-378

Exclusivity Expiration Date : 2028-10-07

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2031-02-23

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Exclusivity Expiration Date

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Exclusivity Code : I-942

Exclusivity Expiration Date : 2027-02-23

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Exclusivity Code

M-305

Exclusivity Expiration Date

2027-04-24

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Exclusivity Code : M-305

Exclusivity Expiration Date : 2027-04-24

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Exclusivity Code

M-82

Exclusivity Expiration Date

2024-02-24

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Exclusivity Code

ODE-284

Exclusivity Expiration Date

2024-09-28

Application Number

208215

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Exclusivity Code

ODE-256

Exclusivity Expiration Date

2026-06-18

Application Number

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Exclusivity Code : ODE-256

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Exclusivity Code

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2024-09-28

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Exclusivity Code : ODE-285

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Exclusivity Code

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Exclusivity Expiration Date

2031-02-23

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