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Last Updated: April 24, 2024

Bromocriptine mesylate - Generic Drug Details


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What are the generic sources for bromocriptine mesylate and what is the scope of patent protection?

Bromocriptine mesylate is the generic ingredient in three branded drugs marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Ss Pharma, Aurobindo Pharma Usa, Padagis Us, Sandoz, and Veroscience, and is included in eight NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bromocriptine mesylate has thirty-two patent family members in thirteen countries.

There are eight drug master file entries for bromocriptine mesylate. Eight suppliers are listed for this compound.

Summary for bromocriptine mesylate
Drug Prices for bromocriptine mesylate

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Recent Clinical Trials for bromocriptine mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Andrew Moshfeghi, MD, MBAPhase 1/Phase 2
Case Western Reserve UniversityPhase 1/Phase 2
VeroSciencePhase 1

See all bromocriptine mesylate clinical trials

Pharmacology for bromocriptine mesylate
Drug ClassErgot Derivative
Medical Subject Heading (MeSH) Categories for bromocriptine mesylate

US Patents and Regulatory Information for bromocriptine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sandoz BROMOCRIPTINE MESYLATE bromocriptine mesylate TABLET;ORAL 074631-001 Jan 13, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE;ORAL 077226-001 Apr 4, 2005 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ss Pharma PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962-002 Mar 1, 1982 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bromocriptine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 ⤷  Try a Trial ⤷  Try a Trial
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 ⤷  Try a Trial ⤷  Try a Trial
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 ⤷  Try a Trial ⤷  Try a Trial
Ss Pharma PARLODEL bromocriptine mesylate TABLET;ORAL 017962-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Veroscience CYCLOSET bromocriptine mesylate TABLET;ORAL 020866-001 May 5, 2009 ⤷  Try a Trial ⤷  Try a Trial
Ss Pharma PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962-002 Mar 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bromocriptine mesylate

Country Patent Number Title Estimated Expiration
Mexico 2019003619 FORMULACIONES DE BROMOCRIPTINA. (BROMOCRIPTINE FORMULATIONS.) ⤷  Try a Trial
Japan 2016026168 代謝障害の治療のためのドーパミン作動薬と第一相インスリン分泌促進薬の組合せ (COMBINATION OF DOPAMINE AGONIST AND FIRST PHASE SECRETAGOGUE FOR TREATMENT OF METABOLIC DISORDERS) ⤷  Try a Trial
European Patent Office 3620155 FORMULATIONS DE BROMOCRIPTINE (BROMOCRIPTINE FORMULATIONS) ⤷  Try a Trial
Japan 2015515984 ブロモクリプチン製剤 ⤷  Try a Trial
Australia 2013256558 Bromocriptine formulations ⤷  Try a Trial
China 102458376 Combination of dopamine agonists plus first phase insulin secretagouges for treatment of metabolic disorders ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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