Brief Description of the
Proposal
Molecule
Therapeutic Area
Relevance & Therapeutic fit
Description/Medical rationale
of Proposed Drug
New Molecule / NDDS / FDCs / New indications for old
drugs / New formulation
Teriparatide
Teriparatide is a form of parathyroid hormone consisting of
the first (N-terminus) 34 amino acids, which is the bioactive
portion of the hormone. It is an effective anabolic (promoting
bone formation) agent used in the treatment of some forms of
osteoporosis.
Epidemiology of disease
Osteoporosis is a systemic skeletal disorder characterized
by low bone mass, micro architectural deterioration of
bone tissue leading to bone fragility, and consequent
increase in fracture risk.
Disease awareness and acceptability of treatment
Teriparatide was approved by the US Food and Drug
Administration (FDA) on 26 November 2002, for the
treatment of osteoporosis in men and postmenopausal
women who are at high risk for having a fracture.
Gaps in Therapy area
NA
Market size & growth
NA (DON’T FILL)
MOA
Teriparatide is a portion of human parathyroid
hormone (PTH), amino acid sequence 1 through 34, of the
complete molecule (containing 84 amino acids). Endogenous
PTH is the primary regulator of calcium and phosphate
metabolism in bone and kidney. PTH increases serum calcium,
partially accomplishing this by increasing bone resorption.
Thus, chronically elevated PTH will deplete bone stores.
However, intermittent exposure to PTH will activate
osteoblasts more than osteoclasts. Thus, once-daily injections
of teriparatide have a net effect of stimulating new bone
formation leading to increased bone mineral density.
Approved Indications
Treatment of postmenopausal women with osteoporosis at
high risk of fracture; increase of bone mass in men with
primary or hypogonadal osteoporosis at high risk of fracture;
treatment of men and women with osteoporosis associated
with sustained systemic glucocorticoid therapy at high risk for
fracture.
 Dose and Duration of Therapy
-20 mcg subcutaneously once a day into the thigh or
abdominal wall.
-Duration of Therapy: Lifetime use greater than 2 years
should only be considered if fracture risk remains high.

For NDDS

Regulatory Pathway India/ Market size & growth

Global NA (DON’T FILL)
Patent status India / Global Off Patent 2019.
Global marketing status Off patent 2019
Competitive landscape Forteo ( Eli Lily ), Zotide (Cipla), Bonista (Sun), Terifrac
(Intas).