Dolutegravir / rilpivirine | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Dolutegravir / Rilpivirine
FDA Orange Book

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Dolutegravir / rilpivirine

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 25 USDMF, 8 EU WC, 2 KDMF, 12 NDC API, 33 Listed Suppliers, $ API Reference Price

51 API Suppliers
25 USDMF
8 EU WC
2 KDMF
12 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

38 Intermediates Suppliers

38 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 28 FDA Orange Book, 10 Europe, 7 Canada, 1 Australia, 57 South Africa, 2 Listed Dossiers

105 FDF Dossiers
28 FDA Orange Book
10 Europe
7 Canada
1 Australia
57 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 22 Kerry, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 13 Roquette, 2 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 33 Direct Compression, 22 Coating Systems & Additives, 20 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 19 Granulation, 18 Thickeners and Stabilizers, 17 Co-Processed Excipients, 16 Controlled & Modified Release, 16 Solubilizers, 13 Chewable & Orodispersible Aids, 12 Parenteral, 11 Taste Masking, 10 Topical, 5 Film Formers & Plasticizers, 3 Coloring Agents, 3 API Stability Enhancers, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 Surfactant & Foaming Agents

70 Fillers, Diluents & Binders
33 Direct Compression
22 Coating Systems & Additives
20 Disintegrants & Superdisintegrants
19 Lubricants & Glidants
19 Granulation
18 Thickeners and Stabilizers
17 Co-Processed Excipients
16 Controlled & Modified Release
16 Solubilizers
13 Chewable & Orodispersible Aids
12 Parenteral
11 Taste Masking
10 Topical
5 Film Formers & Plasticizers
3 Coloring Agents
3 API Stability Enhancers
2 Rheology Modifiers
2 Emulsifying Agents
2 Surfactant & Foaming Agents

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 125 NEWS #PharmaBuzz

6 DATA COMPILATION #PharmaFlow
2 STOCK RECAP #PipelineProspector
125 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 12 Finished Drug Prices, 32 Annual Reports

3 US Medicaid Prescriptions
12 Finished Drug Prices
32 Annual Reports

MARKET PLACE

8 APIs, 8 FDF Dossiers

8 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 5 US Exclusivities, 1 Health Canada Patents

36 US Patents
5 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 435 Xls

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28 All

01 1AUROBINDO PHARMA LTD

02 1AUROBINDO PHARMA USA

03 2CIPLA LTD

04 1CIPLA USA INC.

05 1EMCURE PHARMS LTD

06 2LAURUS GENERICS INC

07 2LAURUS LABS LTD

08 1LUPIN PHARMS

09 5MACLEODS PHARMS LTD

10 1MICRO LABS LTD

11 1MYLAN LABS LTD

12 1MYLAN PHARMS INC

13 1SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

14 8VIIV HLTHCARE

filter Dosage Reset all filters

28 All

01 2FILM;ORAL

02 1TABLET

03 2TABLET, FOR SUSPENSION;ORAL

04 3TABLET; ORAL

05 1TABLET; ORAL SUSPENSION

06 19TABLET;ORAL

filter Regulatory Info Reset all filters

28 All

01 2DISCN

02 6RX

03 20Blank

filter Brand Name Reset all filters

28 All

01 2DOLUTEGRAVIR

02 1DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

03 10DOLUTEGRAVIR SODIUM

04 1DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE

05 2DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

06 1DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

07 3DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

08 1DOVATO

09 1JULUCA

10 3TIVICAY

11 1TIVICAY PD

12 1TRIUMEQ

13 1TRIUMEQ PD

filter RLD Reset all filters

28 All

01 8Yes

02 20Blank

List of Suppliers

Product Main Page

01

AUROBINDO PHARMA LTD

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AUROBINDO PHARMA LTD

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RLD :

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 208355

RX/OTC/DISCN :

RLD :

TE Code :

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02

CIPLA LTD

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RLD :

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 209658

RX/OTC/DISCN :

RLD :

TE Code :

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03

LAURUS LABS LTD

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RLD :

TE Code :

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG; 300MG;300MG

Approval Date :

Application Number : 210787

RX/OTC/DISCN :

RLD :

TE Code :

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04

MYLAN LABS LTD

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RLD :

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : DOLUTEGRAVIR SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 209602

RX/OTC/DISCN :

RLD :

TE Code :

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05

MYLAN PHARMS INC

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MYLAN PHARMS INC

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RLD :

TE Code :

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG;300MG;300MG

Approval Date :

Application Number : 209670

RX/OTC/DISCN :

RLD :

TE Code :

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VIIV HLTHCARE

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RLD : Yes

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2013-08-12

Application Number : 204790

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

VIIV HLTHCARE

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VIIV HLTHCARE

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RLD : Yes

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2016-06-09

Application Number : 204790

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

VIIV HLTHCARE

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VIIV HLTHCARE

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RLD : Yes

TE Code :

DOLUTEGRAVIR SODIUM

Brand Name : TIVICAY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2016-06-09

Application Number : 204790

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

VIIV HLTHCARE

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VIIV HLTHCARE

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RLD : Yes

TE Code :

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Brand Name : TRIUMEQ

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE;EQ 50MG BASE;300MG

Approval Date : 2014-08-22

Application Number : 205551

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

VIIV HLTHCARE

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VIIV HLTHCARE

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RLD : Yes

TE Code :

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Brand Name : JULUCA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE;EQ 25MG BASE

Approval Date : 2017-11-21

Application Number : 210192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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