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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