what is generic, where generic stands and future of generic

1. GENERIC DRUGS
PERSPECTIVE AND
PROSPECTIVE
Gaurav
M. Pharm (Pharmaceutics), Department of Pharmaceutics
School of Pharmaceutical Education and Research, Jamia Hamdard
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on february
2018)

2. Contents
■ Introduction
■ Types of Generics
■ History
■ Generics at present
■ Challenges faced by Generic
■ Future of Generics
■ References
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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3. Generic drugs in simple terms are the copy of the branded
ones having same ingredients, same dosage, same
indications and exactly same pharmacological effects.
Branded Generic
■ Cheaper: Manufacturer only spent
on production.
■ Produced after the expiry of the
patent period.
■ Supply by more then one
company.
■ Studies: Equivalence and
Bioequivalence.
■ Costly : because manufacturer
spents a lot on research,
developing & testing
■ Protected by patent laws from a
specific period.
■ Supplied by only one company
■ Studies: Preclinical and clinical
trials
Have same API but may be different excipients and packaging
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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4. Types of Generics
Pure
generics
Branded
generics
Authorized generics
When the
formulation is
sold by its
original name.
E.g. oral anti
diabetic
Metformin
When the generic
manufacturer
giving a separate
name to its
product.
E.g. Lipitor for
Atorvastatin
When the branded drugs
covered as generics.
Branded companies supply
their drug to a generic firm,
or to their own generic
subsidiary, to market the
product as a generic in
return for royalties. This
may create confusion,
some times in the mind of4
Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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5. History
 1906 Pure Food and drug act- Establishes regulation of
food and drugs.
 1938 Food, Drug and Cosmetic Act- Introduction safety
standards.
 1984 Hatch Waxman Act- Created an abbreviated
mechanism from approval of generic copies of all drugs
originally approved after 1962, by starting that preclinical
and clinical testing does not have to be repeated for
generics.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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6. Hatch- Waxman Act
■ The birth of modern generic
drug industry can be traced
back to the US legislation
known as Hatch-Waxman Act
Steps involves in development of potential generic
drug:
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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7. Objectives
Reduce the cost
associated with
approval of generic
For early
experimental
Motivating to generic
manufacturers
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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8. APPLICANT TRADE NAME GENERIC
NAME
DOSAGE APPROVAL
Pfizer Lipitor Atrovastin
calcium
Tablet 1996
Pfizer TZ-3 Tioconazole Cream 1983
Pfizer Neurontin Gabapentin Tablet 1998
Pfizer Accupril Quinapril HCl Tablet 1991
Sunpharma Temozolomide Temozolomide Capsule 2014
Sunpharma Cequa Cyclosporin Ophthalmic 2018
Astrazeneca Plendil Felodipine Tab; extended
release
1991
Astrazeneca Alvesco Ciclesonide Aerosol:
inhalation
2008
Sandoz Amoxicillin &
clavulanate
potassium
Amoxicillin &
clavulanate
potassium
Suspension: oral 2002
Sandoz Betopic Betaxolol Ophthalmic 1985
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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9. A rough comparison of generic and branded drugs
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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10. RANK COMPANY COUNTRY TURN OVER
1 Teva Pharmaceuticals ISREAL 9.8 $ billion
2 Mylan US 9.4 $ billiom
3 Sandoz GERMANY 9.0 $ billion
4 Pfizer US 4.5 $ billion
5 Sun Pharmaceuticals INDIA 3.6 $ billion
6 Freseniow Kabi USA 2.8 $ billion
7 Endo International IRELAND 2.5 $ billion
8 Lupin INDIAN 2.5 $ billion
9 Sanofi FARNCE 2.0 $ billion
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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11. U S FDA classifies generics as therapeutically equivalent to
those of branded if it meets the following general criteria:
(1)They are approved as safe and effective;
(2)They are pharmaceutical equivalents in that they
(a)Contain identical amounts of the same active drug
ingredient in the same dosage form and route of
administration, and
(b)other applicable standards of strength, quality,
purity, and identity;
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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12. (3)They are bioequivalent in that
a)They do not present a known or potential
bioequivalence problem, and they meet an
acceptable in vitro standard, or
b)If they do present such a known or potential
problem, they are shown to meet an appropriate
bioequivalence standard;
(4)They are adequately labelled;
(5)They are manufactured in compliance with Current
Good Manufacturing Practice regulations.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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13. Generics at present
■ With the rising healthcare costs, the interest in generic
drugs has increased almost all over the world, whether it
is a rich or a poor country. According to the report, the
global generic drug market accounted for around USD
200.20 billion in 2015
■ In India, a government study found that 39 million Indians
were forced into poverty due to health problems and
treatment costs.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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14. ■ It also found that drug prices increased 40% in the ten
years between 2006 and 2016, with production of
generics increasing only 15%, but at the same time
branded drug prices rise 137 percent.
■ Prime Minister of India has planned to make a provision
of free generic drugs through public health clinics and
hospitals, beginning in October 2012, and which
presently is practiced.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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16. Challenges faced by generics
■ Innovator patent extension : Major challenge faced by generics is the
attempt by innovators to constantly extend the period of their exclusive
by listing more and more patents in the orange book due to this generic
developer constantly certify paragraph 3 or 4 either wait for newly listed
patent to expire.(9)
■ Product Selection : Such product Selection is itself a challenge, based
on a variety of factors such as innovator patent expiry, proposed revenue
generation, market situation, patient population, number of other
probable generic players, Active Pharmaceutical Ingredient (API)
availability, complexity of the API/ formulation development and generic’s
research and manufacturing capability.
■ FDA requirements for bioequivalence and high fees : The generic
drug developers burden is the increasing fees prescribed by Generic
Drug User Fee Act(GDUFA) for filling the ANDA and challenges to meet
safety & efficacy requirement.
Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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17.  Price erosion: The concept of “generic” price erosion as compared to
the branded drug pricing, In fact, there would be a cut-throat competition
when various generic versions of the same drug are approved
simultaneously.
example : In 2003, Apotex was awarded 180-day exclusivity for
Paroxetine (Paxil of Glaxo Smith Kline (GSK) and was expected to sell $
575 Million during the 180-day period but sold ~200 Million as GSK
introduced the authorized generics.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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18. Patient Perspective
■ Cost and compliance : Theoretically, generic medications should improve
management and patient compliance because the obstacle of cost has been removed.
■ Inferiority complex : Another potential issue is that patients may be resistant to
going on a generic medication because they perceive them as inferior to their
branded counterpart.
Generics are often considered second-rate medications due to perceived poor
compliance with standard manufacturing practices, lack of patient knowledge
about generics, and influence of the brand-name company
 Patient preference : We often need to consider our patient’s personality and
past experience when deciding between generic and brand drugs as well. One
important question to ask our patients is whether they have taken generics
before and what the outcome was. If the patient had a poor experience, they
may be baised towards branded medications and willing to pay the higher
price.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
february 2018)

19. Future of Generics
■ The generics segment is experiencing
dynamic growth in India and the Asia
Pacific region. According to a 2016 study,
the global generics market is expected to
experience a 10.53 percent compounded
annual growth rate (CAGR) from 2016-2020,
with the value of drugs coming off expired
patents equalling $150 billion by 2021
■ And generic market expected to
reach approx USD 380.60 billion by 2021.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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20. Upcoming off patent drug till 2021
BRAND GENERIC
Acanya benzoyl peroxide/clindamycin
Adcirca tadalafil
Apidra insulin glulisine
Astepro azelastine
Atripla efavirenz/ emtricitabine/ tenofovir
Fentora fentanyl
Finacea azelaic acid
Follistim follitropin beta
Fortesta testosterone
Levitra Vardenafil
Tekturna aliskerin
Tikosyn Dofetilide
Treximet naproxen/sumatriptan
Tyvaso treprostinil
Vesicare solifenacin
Lexiva fosamprenavir
Lotronex alosetron
Lyrica pregabalin
Makena hydroxyprogesterone
Namzaric memantine/donepezil
Pradaxa dabigatran
Promacta eltrombopag
Remodulin Treprostinil
Revlimid Lenalidomide
Sensipar tablet cinacalcet
Spiriva tiotripium
Staxyn vardenafil
Symbicort budesonide/ formotero
Tekamlo aliskerin/amlodipine
Xolair omalizumab
In
2018,
30
Drugs
Will
offpatent
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
february 2018)

21. BRAND GENERIC
Afinitor everolimus
Avastin bevacizumab
Azasite azithromycin
Eliquis apixiban
Emend INJ fosaprepitant
Exelon
patch
rivastigmine
Exjade Deferasirox
Factive gemifloxacin
Firazyr icatibant
Gilenya fingolimod
Invega
sustenna
paliperidone
Orencia abatacept
Prezista darunavir
Ranexa Ranolazine
Rozerem ramelteon
Tarceva Erlotinib
Uloric Febuxostat
BRAND GENERIC
Atrovent HFA ipratropium hfa
Byduredon exenatide
Chantix varenicline
Dexilant dexlansoprazole
Inlyta axitinib
Namenda XR memantine er
Safyral drospirenone/ ethinyl
estradiol/
levomefolate
Saphris asenapine
Silenor doxepin
Sprycel dasatinib
Tykerb lapatinib`
Vigamox moxifloxacin
BRAND GENERIC
Bystolic nebivolol
Crixivan indinavir
Emtriva emtricitabine
Hysingla ER hydrocodone er
Perforomist formoterol
Sutent sunitinib
Veramyst fluticasone
fuoroate
Xarelto rivaroxaban
Zomig ns zolmitriptan
In 2019
In 2020
In 2021
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
february 2018)

22. GBI Research’s survey examined the most promising emerging markets for
generic drug manufacturers. The results of the survey are shown in the follow
figure-1
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
february 2018)

23. ■ Indian pharmaceutical companies are already well
positioned in some of the generic pharmaceutical markets
of developed nations.
■ This is due to product development skills through advanced
technological capabilities, and low-cost manufacturing.
Ranbaxy (now Sun Pharma) was the first Indian
pharmaceutical company to recognize and take advantage
of the generics market. After the acquisition by Sun
Pharma, the company’s net worth in 2015 was around $4
billion. Other Indian companies that are also very active in
the world’s generic drug industry are Dr. Reddy’s and Cipla.
■ According to a recent analysis, the Indian generics market
is expected to exceed $27.9 billion by 2020, from the value
of $13.1 billion in 2015, registering a CAGR of 16.3%.
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Krishnan S,Challenges to generic drug development, The Pharma Review (Published on
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24. References
1. Ghate, S. R., Biskupiak, J. E., Ye, X., Hagan, M., Kwong, W. J., Fox, E. S., & Brixner, D. I.
(2011). Hemorrhagic and Thrombotic Events Associated with Generic Substitution of
Warfarin in Patients with Atrial Fibrillation: A Retrospective Analysis. Annals of
Pharmacotherapy, 45(6), 701–712. doi:10.1345/aph.1p593
2. Toni Johnson : http://www.cfr.org/drugs/debate-over-generic-drug-trade/p18055 (Updated:
August 3/11)
3. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-
gen/documents/document/ucm071436.pdf (Accessed on 22-11-18)
4. http://professionals.epilepsy.com/page/hallway_generics.html (Accessed on 22-11-18)
5. http://medsdebate.com/lib/generics/ (Accessed on 22-11-18)
6. Editorial, GENERICS VS BRANDED DRUGS!, J MGIMS, September 2012, Vol 17, No (ii), i
– iv
7. Chawla K, et. al. (2014). A Global Comparison Between Brand-Name and Generic Drugs.
Indian Journal of Pharmacy Practice, Vol 7, Issue 3, Jul–Sep, 2014
8. Pharmalife article, The future of generic drugs and strategies for commercial success.
(Published on 17/02/17 at 10:22am) 24
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25. 9. Krishnan S,Challenges to generic drug development, The Pharma
Review (Published on february 2018)
10. Bera A, Mukherjee A(2012), The importance of generic drugs in India,
International journal of pharmaceutical, chemical and biological science,
IJPCBS 2012, 2(4), 575-587.
11. Pierini D, Anderson K,, How generic drug are made, US
Pharm.2003;38(6)(generic drug review):26-31
12. https://www.pti-nps.com/nps/wp-content/uploads/2017/04/NPS_Drugs-
Coming-Off-Patent-by-2022-Web.pdf
13. https://www.drugpatentwatch.com/p/applicant/Sandoz
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