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Clinigen Regulatory Milestones
Track drug and patent expiries along with geographies impacted.
A sample of Clinigen Regulatory Milestones data
| Drug Name | Generic Name | Brand Name | Company Name | Expiry Geography | Constraining Patent Number | Constraining Patent Expiry | Drug Expiry (Estimated) | Highest Development Stage |
|---|---|---|---|---|---|---|---|---|
| Deserunt mollit sunt Lorem | Lorem | Lorem | Pfizer Inc | Lorem | WXYZ | Lorem | Pending | Lorem |
| dexrazoxane | dexrazoxane | Totect | Clinigen Ltd | EU | EP1162981 | Mar-2020 | Mar-2020 | Marketed |
| dexrazoxane | dexrazoxane | Totect | Clinigen Ltd | United States | US6727253 | Mar-2020 | - | Withdrawn (Marketed) |
| amifostine | amifostine | Ethyol | Clinigen Ltd | United States | US5994409 | Dec-2017 | Dec-2017 | Marketed |
A sample of Clinigen Ltd Review Designation data
| Drug Name | Generic Name | Company Name | Indication | Geography | Designation Type | Designation Status | Designation Date |
|---|---|---|---|---|---|---|---|
| Deserunt mollit sunt Lorem laborum do id aliqua dolore | Lorem | Pfizer Inc | Lorem | Lorem | Lorem | Lorem | 02 Nov 2021 |
| mercaptopurine | mercaptopurine | Nova Laboratories Ltd | Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) | EU | Orphan Drug Designation | Designated/Approved | 30 Apr 2009 |
| idursulfase beta | idursulfase beta [INN] | GC Biopharma Corp | Mucopolysaccharidosis II (MPS II) (Hunter Syndrome ) | EU | Orphan Drug Designation | Designated | 02 Nov 2021 |
| idursulfase beta | idursulfase beta [INN] | Clinigen KK | Mucopolysaccharidosis II (MPS II) (Hunter Syndrome ) | Japan | Orphan Drug Designation | Designated/Approved | 28 Feb 2020 |
Feature
Regulatory Milestones provides an interactive, comprehensive, and analytical view of Drug and Constraining Patent Expiry and Exclusivity for Marketed and Pipeline (till preclinical development stage) pharmaceutical drugs in the United States (US), Europe (United Kingdom, Germany, France, Italy, and Spain) and Japan.
Benefit
Regulatory Milestones provides patent information for all novel Marketed and Pipeline pharmaceutical drugs available in the US, Europe (United Kingdom, Germany, France, Italy, and Spain) and Japan.
The Drug Expiry filters include Expiry Geography and Expiry Date as well as US-specific information.
The Drug Expiry date is based on the Constraining Patent Expiry, Patent Term Extension or Supplementary Protection Certificate (depending on the regulator), Exclusivity analysis and specific information on Review Designations granted by regulators.
US-specific information includes Exclusivity Type and Paragraph IV Certification filing under the Hatch Waxman Act (Paragraph IV).
Value
Regulatory Milestones is easily accessible and features a user-friendly platform. The tool includes attributes relating to Drug Expiry and Constraining Patents as well as attributes from Drugs and Companies .
Clients can utilize Regulatory Milestones to save time and effort through accumulated expiry information from various sources and registries in a standardized comparable format.
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