Orphan Drug & Rare Disease Intelligence
Orphan designation · Exclusivity tracking · Global approvals
Watson Labs Inc — Topical
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Feb 7, 2006
US FDA ✓EMA EU PendingPMDA JP Pending
Pharmobedient — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jul 29, 2005
US FDA ✓EMA EU PendingPMDA JP Pending
Poythress — Topical
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Sep 17, 1940
US FDA ✓EMA EU PendingPMDA JP Pending
Natco Pharma — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Apr 26, 2019
US FDA ✓EMA EU PendingPMDA JP Pending
Able — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Aug 22, 2003
US FDA ✓EMA EU PendingPMDA JP Pending
Roxane — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: May 10, 1976
US FDA ✓EMA EU PendingPMDA JP Pending
Watson Labs — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jul 8, 1987
US FDA ✓EMA EU PendingPMDA JP Pending
Ivax Pharms — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: May 11, 1977
US FDA ✓EMA EU PendingPMDA JP Pending
Watson Labs — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Unknown Date
US FDA ✓EMA EU PendingPMDA JP Pending
Sanofi Aventis Us — Oral, Rectal
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Sep 18, 1987
US FDA ✓EMA EU PendingPMDA JP Pending
Teva Parenteral — Subcutaneous
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jul 29, 2008
US FDA ✓EMA EU PendingPMDA JP Pending
Chartwell Rx — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Sep 24, 2012
US FDA ✓EMA EU PendingPMDA JP Pending
Barr Labs Inc — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Nov 29, 2012
US FDA ✓EMA EU PendingPMDA JP Pending
Alembic Pharms Ltd — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: May 11, 2020
US FDA ✓EMA EU PendingPMDA JP Pending
Septodont Inc — Injection
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Nov 2, 2018
US FDA ✓EMA EU PendingPMDA JP Pending
Dr Reddys — Injection
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Aug 6, 1986
US FDA ✓EMA EU PendingPMDA JP Pending
Esi — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Nov 28, 1997
US FDA ✓EMA EU PendingPMDA JP Pending
Alra — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jul 21, 1982
US FDA ✓EMA EU PendingPMDA JP Pending
Pharmeral — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: May 8, 1974
US FDA ✓EMA EU PendingPMDA JP Pending
Torrent Pharms — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Oct 13, 2016
US FDA ✓EMA EU PendingPMDA JP Pending
Pfizer — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jan 6, 1998
US FDA ✓EMA EU PendingPMDA JP Pending
Rising — Injection
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Aug 28, 2012
US FDA ✓EMA EU PendingPMDA JP Pending
Udl — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Unknown Date
US FDA ✓EMA EU PendingPMDA JP Pending
Actavis Mid Atlantic — Oral
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Jun 3, 1991
US FDA ✓EMA EU PendingPMDA JP Pending
Abraxis Pharm — Injection
Approved7yr exclusivity
Prevalence: <200,000 (US)Population: Rare DiseaseDesignated: Unknown Date
US FDA ✓EMA EU PendingPMDA JP Pending
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