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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Mallinckrodt
Johnson and Johnson
Express Scripts
Merck
Fuji

Generated: March 19, 2019

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Regulatory Exclusivity: ORPHAN DRUG EXCLUSIVITY

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Drugs with Orphan Drug Exclusivity Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes ➤ Sign Up FOR SEQUENTIAL USE FOR THE TREATMENT OF CYANIDE POISONING THAT IS JUDGED TO BE LIFE-THREATENING
Hope Pharms SODIUM NITRITE sodium nitrite SOLUTION;INTRAVENOUS 203922-001 Feb 14, 2012 RX Yes Yes ➤ Sign Up FOR SEQUENTIAL USE FOR THE TREATMENT OF CYANIDE POISONING THAT IS JUDGED TO BE LIFE-THREATENING
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ➤ Sign Up FOR SEQUENTIAL USE FOR THE TREATMENT OF CYANIDE POISONING THAT IS JUDGED TO BE LIFE-THREATENING
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes ➤ Sign Up FOR THE MANAGEMENT OF POSTHERPETIC NEURALGIA
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes ➤ Sign Up FOR THE MANAGEMENT OF POSTHERPETIC NEURALGIA
Amag Pharma Usa MAKENA hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-001 Feb 3, 2011 RX Yes Yes ➤ Sign Up TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH
Amag Pharma Usa MAKENA PRESERVATIVE FREE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-002 Feb 19, 2016 AP RX Yes Yes ➤ Sign Up TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
AstraZeneca
Farmers Insurance
Accenture
Teva
Merck

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