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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Dow
Moodys
US Department of Justice
Teva
Chinese Patent Office
Merck
Chubb
AstraZeneca

Generated: May 24, 2018

DrugPatentWatch Database Preview

Regulatory Exclusivity Expiring in 2019

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Drugs with Regulatory Exclusivity Expiring in 2019

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ➤ Sign Up PART OF COMBINATION THERAPY IN ADULTS (GREATER THAN OR EQUAL TO 18 YEARS) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 RX Yes No ➤ Sign Up INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 RX Yes No ➤ Sign Up INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 RX Yes No ➤ Sign Up INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
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:

Fuji
Harvard Business School
US Army
Deloitte
Merck
Teva
Cipla
Mallinckrodt
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.