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Information, Expiry, & Status of FDA Orange Book Exclusivities covering Dexamethasone Acetate

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Product

Dexamethasone Acetate
Betamethasone Acetate
U.S. EXCLUSIVITIES

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Symbiotec Dexamethasone

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Dexamethasone Acetate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

72 API Suppliers, 26 USDMF, 9 CEP/COS, 6 JDMF, 2 EU WC, 7 KDMF, 26 NDC API, 2 VMF, 49 Listed Suppliers, $ API Reference Price

72 API Suppliers
26 USDMF
9 CEP/COS
6 JDMF
2 EU WC
7 KDMF
26 NDC API
2 VMF
49 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

213 Drugs in Development

213 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

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

360 FDF Dossiers, 130 FDA Orange Book, 113 Europe, 27 Canada, 10 Australia, 17 South Africa, 63 Listed Dossiers

360 FDF Dossiers
130 FDA Orange Book
113 Europe
27 Canada
10 Australia
17 South Africa
63 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OPHTHALMIC - 0.1%, SUSPENSION/DROPS;OTIC - 0.3%;0.1%, OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM, SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%, OINTMENT;OPHTHALMIC - 0.1%;0.3%, SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%, TABLET;ORAL - 1.5MG, TABLET;ORAL - 0.5MG, TABLET;ORAL - 4MG, TABLET;ORAL - 0.75MG, TABLET;ORAL - 2MG, SOLUTION;ORAL - 0.5MG/5ML, ELIXIR;ORAL - 0.5MG/5ML, TABLET;ORAL - 1MG, TABLET;ORAL - 6MG

SUSPENSION/DROPS;OPHTHALMIC - 0.1%
SUSPENSION/DROPS;OTIC - 0.3%;0.1%
OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%
OINTMENT;OPHTHALMIC - 0.1%;0.3%
SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%
TABLET;ORAL - 1.5MG
TABLET;ORAL - 0.5MG
TABLET;ORAL - 4MG
TABLET;ORAL - 0.75MG
TABLET;ORAL - 2MG
SOLUTION;ORAL - 0.5MG/5ML
ELIXIR;ORAL - 0.5MG/5ML
TABLET;ORAL - 1MG
TABLET;ORAL - 6MG

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 7 SPI Pharma, 8 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 10 Corel Pharma Chem, 1 Curia, 6 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 30 Roquette, 15 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 31 Direct Compression, 28 Thickeners and Stabilizers, 25 Solubilizers, 22 Controlled & Modified Release, 21 Parenteral, 20 Topical, 19 Film Formers & Plasticizers, 19 Disintegrants & Superdisintegrants, 17 Taste Masking, 17 Co-Processed Excipients, 16 Granulation, 13 Lubricants & Glidants, 9 Rheology Modifiers, 9 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

70 Fillers, Diluents & Binders
45 Coating Systems & Additives
31 Direct Compression
28 Thickeners and Stabilizers
25 Solubilizers
22 Controlled & Modified Release
21 Parenteral
20 Topical
19 Film Formers & Plasticizers
19 Disintegrants & Superdisintegrants
17 Taste Masking
17 Co-Processed Excipients
16 Granulation
13 Lubricants & Glidants
9 Rheology Modifiers
9 Chewable & Orodispersible Aids
7 Emulsifying Agents
5 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
2 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 264 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
264 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 110 Finished Drug Prices, 6 Annual Reports

7 US Medicaid Prescriptions
110 Finished Drug Prices
6 Annual Reports

MARKET PLACE

61 APIs, 59 FDF Dossiers

61 APIs
59 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 3 US Exclusivities, 3 Health Canada Patents

16 US Patents
3 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 EDQM, 2 USP, 2 JP, 8 Others

8 EDQM
2 USP
2 JP
8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 698 Xls

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filter Company Name Reset all filters

3 All

01 1APOTEX

02 1DEXCEL

03 1OCULAR THERAPEUTIX

filter Product Reset all filters

3 All

01 3DEXAMETHASONE

filter Exclusivity Expiration Date Reset all filters

3 All

01 12024-04-29

02 12024-10-07

03 12026-10-03

filter Exclusivity Code Reset all filters

3 All

01 1CGT

02 1I-876

03 1ODE-271

EUROAPI Dexamethasone

US Patents
US Exclusivities
Health Canada Patents

Product Main Page

DEXCEL

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DEXAMETHASONE

Portfolio PDF

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Exclusivity Code

ODE-271

Exclusivity Expiration Date

2026-10-03

Application Number

211379

Product Number

1

Exclusivity Details

01

DEXCEL

Luxepack

Not Confirmed

DEXCEL

Israel

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Not Confirmed

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DEXAMETHASONE

Exclusivity Code : ODE-271

Exclusivity Expiration Date : 2026-10-03

Application Number : 211379

Product Number : 1

Exclusivity Details :

Portfolio PDF

Product Web Link

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Corporate PDF

OCULAR THERAPEUTIX

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Digital Content

DEXAMETHASONE

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Exclusivity Code

I-876

Exclusivity Expiration Date

2024-10-07

Application Number

208742

Product Number

1

Exclusivity Details

02

OCULAR THERAPEUTIX

Luxepack

Not Confirmed

OCULAR THERAPEUTIX

U.S.A

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Not Confirmed

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DEXAMETHASONE

Exclusivity Code : I-876

Exclusivity Expiration Date : 2024-10-07

Application Number : 208742

Product Number : 1

Exclusivity Details :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

APOTEX

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Digital Content

DEXAMETHASONE

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Exclusivity Code

CGT

Exclusivity Expiration Date

2024-04-29

Application Number

217695

Product Number

3

Exclusivity Details

03

APOTEX

Luxepack

Not Confirmed

APOTEX

Canada

Luxepack

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

DEXAMETHASONE

Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-04-29

Application Number : 217695

Product Number : 3

Exclusivity Details :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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