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Information, Expiry, & Status of FDA Orange Book Exclusivities covering Acetaminophen

Client Email

Product

Acetaminophen
4'-Hydroxyacetophenone
CAS 121-71-1
CAS 134-20-3
Aspirin
Caffeine
4-Nitrophenol
Acetanilide
CAS 556-08-1
Benorilate
U.S. EXCLUSIVITIES

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Acetaminophen

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

116 API Suppliers, 80 USDMF, 22 CEP/COS, 16 JDMF, 7 EU WC, 109 KDMF, 106 NDC API, 30 Listed Suppliers, $ API Reference Price

116 API Suppliers
80 USDMF
22 CEP/COS
16 JDMF
7 EU WC
109 KDMF
106 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 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

FINISHED DOSAGE FORMULATIONS

2529 FDF Dossiers, 730 FDA Orange Book, 503 Europe, 290 Canada, 75 Australia, 402 South Africa, 529 Listed Dossiers

2529 FDF Dossiers
730 FDA Orange Book
503 Europe
290 Canada
75 Australia
402 South Africa
529 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

SUPPOSITORY;RECTAL - 120MG
SUPPOSITORY;RECTAL - 325MG
SUPPOSITORY;RECTAL - 650MG
SUPPOSITORY;RECTAL - 80MG
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 250MG;250MG;65MG
TABLET;ORAL - 325MG;37.5MG
SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 300MG;15MG
TABLET;ORAL - 300MG;30MG
TABLET;ORAL - 300MG;60MG
TABLET;ORAL - 325MG;5MG
TABLET;ORAL - 325MG;50MG;40MG
TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 1 Evonik, 14 Rochem International Inc, 31 SPI Pharma, 2 Seqens, 32 DKSH, 3 Jai Radhe Sales, 3 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 18 Gangwal Healthcare, 22 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 13 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 13 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

146 Fillers, Diluents & Binders, 81 Thickeners and Stabilizers, 71 Solubilizers, 69 Coating Systems & Additives, 62 Direct Compression, 60 Taste Masking, 54 Topical, 50 Disintegrants & Superdisintegrants, 46 Parenteral, 40 Film Formers & Plasticizers, 40 Granulation, 40 Controlled & Modified Release, 40 Lubricants & Glidants, 27 Chewable & Orodispersible Aids, 26 Emulsifying Agents, 24 Co-Processed Excipients, 18 Rheology Modifiers, 15 Surfactant & Foaming Agents, 13 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

146 Fillers, Diluents & Binders
81 Thickeners and Stabilizers
71 Solubilizers
69 Coating Systems & Additives
62 Direct Compression
60 Taste Masking
54 Topical
50 Disintegrants & Superdisintegrants
46 Parenteral
40 Film Formers & Plasticizers
40 Granulation
40 Controlled & Modified Release
40 Lubricants & Glidants
27 Chewable & Orodispersible Aids
26 Emulsifying Agents
24 Co-Processed Excipients
18 Rheology Modifiers
15 Surfactant & Foaming Agents
13 API Stability Enhancers
9 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

13 DATA COMPILATION #PharmaFlow, 340 NEWS #PharmaBuzz

13 DATA COMPILATION #PharmaFlow
340 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 406 Finished Drug Prices, 20 Annual Reports

7 US Medicaid Prescriptions
406 Finished Drug Prices
20 Annual Reports

MARKET PLACE

173 APIs, 95 FDF Dossiers

173 APIs
95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 3 Health Canada Patents

41 US Patents
2 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 7 USP, 1 JP, 26 Others

1 EDQM
7 USP
1 JP
26 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

2 BioAnalytical Methods
8 Analytical Methods

$ API Ref.Price (USD/KG) : 7 Xls

Filters

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FILTER :

filter Company Name Reset all filters

2 All

01 1AFT PHARMS LTD

02 1GLENMARK PHARMS LTD

filter Product Reset all filters

2 All

01 2ACETAMINOPHEN; IBUPROFEN

filter Exclusivity Expiration Date Reset all filters

2 All

01 12024-11-03

02 12026-03-01

filter Exclusivity Code Reset all filters

2 All

01 1NP

02 1PC

Granules Paracetamol

US Patents
US Exclusivities
Health Canada Patents

Product Main Page

AFT PHARMS LTD

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Digital Content

ACETAMINOPHEN; IBUPROFEN

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Exclusivity Code

NP

Exclusivity Expiration Date

2026-03-01

Application Number

209471

Product Number

1

Exclusivity Details

01

AFT PHARMS LTD

ACETAMINOPHEN; IBUPROFEN

Fall Technical Meeting

Not Confirmed

AFT PHARMS LTD

New Zealand

Fall Technical Meeting

Not Confirmed

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ACETAMINOPHEN; IBUPROFEN

Exclusivity Code : NP

Exclusivity Expiration Date : 2026-03-01

Application Number : 209471

Product Number : 1

Exclusivity Details :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

GLENMARK PHARMS LTD

Contact Supplier

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.

Post an Enquiry

Post an Enquiry

Digital Content

ACETAMINOPHEN; IBUPROFEN

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Exclusivity Code

PC

Exclusivity Expiration Date

2024-11-03

Application Number

218311

Product Number

1

Exclusivity Details

02

GLENMARK PHARMS LTD

ACETAMINOPHEN; IBUPROFEN