|
Product Pipeline
|
Programs Under Development |
Branded Products (a) |
Therapeutic
Category |
NDA / ANDA |
Development Stage (b) |
Partnered |
ELI-154
Oxycodone CR
Once a day |
NA |
Pain |
NDA |
Phase III pending |
No |
ELI-216
Abuse Resistance Product for use with
oxycodone or other opioids |
N/A |
Pain |
NDA |
Phase III pending |
No |
Undisclosed
Twice a day |
Undisclosed |
Anti-infective |
ANDA |
Pilot BE study complete |
No |
Undisclosed
Once a day |
Undisclosed |
Gastrointestinal |
ANDA
|
Pilot BE study complete |
Yes |
|
Commercial
Products |
|
Commercial
Product |
Branded Products (a) |
Therapeutic
Category |
Commercial
Status |
Partner |
Lodrane®
Once a Day |
N/A |
Allergy |
Launched |
ECR Pharmaceuticals |
Lodrane 24D ®
Once a day |
N/A |
Allergy |
Launched |
ECR Pharmaceuticals |
|
Phentermine HCl 37.5 mg tablets |
Adipex-P® 37.5
mg |
Bariatric |
Launched |
Precision Dose, Inc. /
TAGI |
Hydromorphone
Hydrochloride
8 mg tablets |
Dilaudid®
8 mg |
Pain |
FDA Approved, Launch pending |
Precision Dose, Inc. /
TAGI |
Naltrexone Hydrochloride
50 mg |
ReVia®
and Depade® |
Opioid Receptor Antagonist |
FDA Approved, Launch pending |
Precision Dose, Inc. /
TAGI |
(a) The name of our
competitor’s branded product. N/A
(b) Preclinical testing refers to
studies done before initiation of any human studies. Pilot Phase I studies for
the NDA products are generally preliminary studies done in healthy human
subjects to assess the tolerance/safety and pharmacokinetics (PK) of the
product. Additional larger studies in humans will be required prior to
submission of this product to the FDA for review. Pilot bioequivalence (BE)
studies are initial studies done in humans for generic products and are used to
assess the likelihood of achieving bioequivalence for generic products. Larger
pivotal bioequivalence studies will be required prior to submission of the
product for FDA for review.
|
