Branded Generics: A Gateway to Emerging Markets

Pintu Bhushan MitraPharmaceutical Marketing Professional

Dhaka, Bangladesh

Branded Generics

• A branded generic is a drug that is bioequivalent to the original product, but is now marketed under another company's brand name.

•Acetaminophen, or Paracetamol•Alprazolam•Amoxicillin•Asprin, or Acetylsalicylic Acid•Azithromycin•Diclofenac

Branded Drugs

Branded drugs are also called as the "Innovator drugs" and are at first available in the market as new chemical entities.

Difference Based On The Patent Protection

• Brand Drug : produced by a company which holds the patent for 20 years

• Branded generic : Market by the pharmaceutical companies only after the patent protection period expires, i.e. only after 20 years.

Difference In The Cost

Difference In The Color And Shape

• The Trademark laws from the brand name drug companies restricts the generic drug manufacturing companies to produce the similar looking drugs and thus they look different in the color and also in the shape.

Similarities Between Branded Drugs And The Generic Drugs

Like the branded drugs, the FDA or the Food and Drug Administration requires to have the same quality and must be tested before making available in the market

Generic Drugs & market

Classification of generics

In recent years, a new segment emerged—Specialty Generics

Generic (off patent)

Unbranded Generic

Branded Generic

Company Branded Generic

Authorized Generic

Specialty Generic

Differentiation of unbranded, branded, and company-branded generics.

Specialty Generics

• There are two categories of specialty generics:– New Therapeutic Entities (NTE)-also known as “super generics,

“value-added generics,” or “hybrid generics.”– Complex Generic

New Therapeutic Entities(NTEs)

• New Therapeutic Entities(NTEs) is based on known and approved chemical molecules which are reformulated, repurposed or re-engineered to be delivered in a new way to address specific, unmet patient needs.

Techniques to develop NTE

Complex Generics

• Complex generics are large and formulations or active ingredients used to treat chronic and life threatening diseases like cancer, Hepatitis C, and HIV.

Complex generics classification

Global Generics Market

Factors for rapid growth in the global generic pharmaceutical industry

• Governments’ and payers’ need to rein in rapidly increasing healthcare expenditures

• Growing middle class in emerging markets• Longer life expectancy• Large number of patent expiries for innovator drugs• Companies have been merging in the hopes to

reduce competition or acquiring R&D pipelines• Biosimilars Emerging

Opportunities within a changing Asian market

Generic drug industry’s value chain

ChallengesHeavy competition

Government-mandated price cuts

Patents Rights in Clusters or Divisions

Influencing the Medical Fraternity

Market Entry Strategies

• 1)Contract manufacturer• 2) Strategic Partner• 3) License IP• 4) Distribution Deal• 5) Joint Venture or invest in existing company• 6) Acquire control of existing company• 7) Set up NewCo– i) Manufacturing step– ii) Sales & Marketing

Thank you