Seqens Seqens

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    Find PharmaFlow Article for DSSTox_CID_28993

    Client Email Product

    DSSTox_CID_28993

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    DOSSIERs // Finished Dosage Formulations

    DRUG PRODUCT COMPOSITION

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS

    ANALYTICAL SOLUTION(s)

    DIGITAL CONTENT

    PharmaCompass
    Product SearchProduct Search
    API SUPPLIERS
    API Suppliers

    API Suppliers

    31
    US DMFs Filed

    US DMFs Filed

    15
    CEP/COS Certifications

    CEP/COS Certifications

    2
    JDMFs Filed

    JDMFs Filed

    0

    Other Certificates

    Other Certificates

    10
    Other Suppliers

    Other Suppliers

    16
    API REF. PRICE (USD / KG)
    4,155

    API Market Place

    1
    INTERMEDIATES

    0

    DOSSIERS // FDF
    USA (Orange Book)

    USA (Orange Book)

    22
    Europe

    Europe

    2
    Canada

    Canada

    0

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Uploaded Dossiers

    Uploaded Dossiers

    4
    GLOBAL SALES (USD Million)

    U.S. Medicaid

    1,067.00

    Annual Reports

    0

    FDF Market Place

    0

    EXCIPIENTS
    183
    PATENTS & EXCLUSIVITIES

    USFDA Orange Book Patents

    0

    USFDA Exclusivities

    0

    DIGITAL CONTENT

    Blog #PharmaFlow

    1

    News

    6
    REF STANDARD

    EDQM

    0

    USP

    0

    JP

    0

    Other Listed Suppliers

    1
    SERVICES

    0

    left grey arrow
    right gray arrow
    • TABLET;ORAL - EQ 10MG BASE
    • TABLET;ORAL - EQ 5MG BASE
    BlogBlog
    Full View ScreenFull Screen View
    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    With almost 30,000 Drug Master Files (DMFs) submitted to the FDA, reviewing the filings of only the first quarter of 2015, provides an indicator on the current areas of focus of generic pharmaceutical companies. A detailed evaluation of the 241 filings for active pharmaceutical ingredients only, made us find some interesting trends worth sharing. European Blockbuster battle! Of the 241 DMFs, 21 APIs had more than one DMF filing and accounted for 25% of the total filings. Interestingly, 20 DMFs  were for only three APIs: AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476 million, already had DMF filings from Dr. Reddy’s, Mylan, Polpharma and Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players like Teva, Alembic, Lek and others, AstraZeneca should brace itself for some serious generic onslaught.  While the 9 filings for Ticagrelor were the most for any single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the focus of the generic companies is understandable as Rivaroxaban had sales in excess of $3 billion and year-on-year growth in excess of 70%. However, patents currently protect the product till 2020, so patience is needed before generics can access this golden opportunity. Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others? Exclusive but not patented There are products, which have no patent protection, but the market is protected by FDA granted exclusivities (learn more on patents and exclusivities from the FDA website). An opportunity for generic companies to gain significant market share of a multi-hundred million dollar market, without any litigation risk or cost is something companies dream about.  As the time of exclusivity expiry nears, Clobazam, Tetrabenazine, Hydroxyprogesterone Caproate, Deferiprone and Trypan Blue will all see increased generic activity as their Drug Master Files have been submitted. Fragmented Activity More than 80% of the DMF submissions were made by companies who filed only a single product. While the products varied from simple compounds like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in the first quarter with almost 30 submitting a DMF for the first time. An expanding list of suppliers who support DMFs increases options for sourcing managers.  However, a fragmented supplier base limits the industrial scale companies can achieve and raises concerns regarding how many can successfully sustain compliance standards under increased regulatory scrutiny? The Next Generic Wave Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year.  While Dagibatran saw a flurry of activity over the last two years with almost 15 DMF filings, there were no additional filings this year. On the other hand, Apixaban, which generated $774 million for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done over a year ago. The export data out of India, reviewed on PharmaCompass, for Apixaban, indicates that product development is already complete so it is just a matter of time before the filings begin.   Conclusion: Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions. If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of major pharmaceutical companies to review the various products along with their revenues (click here): Table: Products with more than one DMF filing in Q1 2015 PRODUCT NAME DMF FILINGS TICAGRELOR 9 RIVAROXABAN 7 LINAGLIPTIN 4 APREPITANT 3 CINACALCET HYDROCHLORIDE 3 ATAZANAVIR SULFATE 2 ATORVASTATIN CALCIUM TRIHYDRATE 2 CLOBAZAM 2 CLOFARABINE 2 DEFERASIROX 2 DIMETHYL FUMARATE 2 EZETIMIBE 2 ICATIBANT ACETATE 2 LURASIDONE HYDROCHLORIDE 2 MELPHALAN HYDROCHLORIDE 2 OLANZAPINE 2 OLMESARTAN MEDOXOMIL USP 2 PRASUGREL HYDROCHLORIDE 2 RIVASTIGMINE USP 2 ROSUVASTATIN CALCIUM 2 SOLIFENACINE SUCCINATE 2

    Impressions: 8782

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/the-next-generic-attack-brilinta-ticagrelor-xarelto-rivaroxaban-tradjenta-linagliptin-and

    #PharmaFlow by PHARMACOMPASS
    13 May 2015
    Share Share
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    veranova-m-2024-04-22

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Post Enquiry
    POST ENQUIRY

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search