Insight Pharma

Product Launch Strategy

Product launches serve as defining moments for pharmaceutical companies to create sustained value. Well-managed launches provide the single most powerful way to offset the revenue shortfalls of the approaching patent cliff. Launching new pharmaceutical products has never been simple, with marketers well aware that a poorly planned and executed initial launch for a new product makes it very difficult to be successful in the long run. Whether it is an innovator company or a generic company, a proper planning and strategy is the only way for a perfect product launch. Knowing key patents expiry, data exclusivity and any patent challenge opportunity is critical to plan for product launch.

IBRSoluTions provides product launch & strategy services helping companies in healthcare industry to take informed decision about product launch. We provide intelligence about product key patents, their expiry, data exclusivity details as well opportunity for patent challenge in different territories around the world. We recommend various options of product launch & strategies with detailed analysis.

IBRSoluTions provides the following Product Launch Strategy Services:

Product Launch Strategy Services
  • Key Patents Expiry

  • Data Exclusivity

  • Paragraph IV Patent Strategy

Key Patents Expiry

  • The maximum term of a patent is 20 years from the date of its filing. But in some countries, the term of the patent may be extended as compensation to the delay from the patent office during issuance of the patent whereas in some countries, there are also some provisions to extend the term of the patents to compensate the delay in regulatory approval of the drug/device. There is also dissimilarity of term of patent in different countries which were filed before TRIPS. Again the term of the patent can be extended with pediatric exclusivity. So patent having a single priority date may have different expiry in different countries. It is important for the business managers and the R&D scientist to know the exact expiry of the key blocking patent so that they can plan for their start of development and launch of the product.

    Our patent expiry service gives our clients the exact expiry of the key patents in different countries for a specific product. We provide the expiry of the patent with SPC for all the EU states. We also provide the expiry of the patent in different countries like USA, Australia, Canada, Japan, Brazil, Mexico, South Africa, Philippines and New Zealand etc. including India.

Data Exclusivity

  • To launch a new drug/device in the market, clinical test data is required to be submitted to a regulatory agency to prove its safety and efficacy. Doing clinical trials for approval of a product requires huge time and money. A generic copy of the approved product does not require any clinical data except the BA/BE study for its approval as it depends of the clinical finding of the original products. To avoid the generic competition for some period of time, so that the innovator can get its innovation benefit and to promote new invention, regulatory bodies protect the clinical data for a fixed time period. Hence the generics company can file their product after the expiry of the data exclusivity period.

    Data exclusivity period is different in different countries. There are also different types of data exclusivity like New Chemical Entity (NCE), Orphan Drug Exclusivity, Pediatric Exclusivity, additional exclusivity for different indication, new dosage forms, new strengths, new forms of Active Ingredients, etc. These exclusivities have different implications while making and launching a generic copy of the already existing product.

    We provide data exclusivity expiry service to our clients at an affordable price in different countries. We provide the data exclusivity service with detailed reports about its implications on filing and launching generic products. Our foolproof data exclusivity service helps our clients to plan for project initiation, filing of the product with the regulatory body and the launch of the product.

Paragraph IV Patent Strategy

  • Intention to market a generic pharmaceutical product in USA before the expiration of a patent (Orange Book) relating to the brand name drug leads to paragraph IV certification and subsequently to high cost litigation. Though every generic company wants to be the first-to-file to get the 180 exclusivity, there should be some rational to file a paragraph IV certification and again that to be the first-to-file to succeed in the competitive business environment.

    As many smaller companies have also chosen to follow the Paragraph IV path, attempting to balance risk versus reward in a highly competitive marketplace, there need a good paragraph IV patent strategy to succeed in the business.  Our paragraph IV Patent Strategy service includes a well explained report and consultation, which details all aspects for filing a paragraph IV certification like rewards, risks, competition, cost etc. and help higher management to take conclusive decision.

    The paragraph IV Patent Strategy service provides by accounting the following factors:
    Cost/benefit considerations behind Paragraph IV strategy
    Rewards and risks calculation of pursuing first-to-file status
    Potential pitfall of the push to be first to file
    Value of being a subsequent filer

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