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Orange Book drug · Brand (NDA)

Cycloset

Bromocriptine Mesylate

RLDNDA 020866 Veroscience
Approved
May 05, 2009
Strengths
1
Listed patents
13

What does the FDA Orange Book show for Cycloset?

Cycloset contains Bromocriptine Mesylate and is the new drug FDA Orange Book record for NDA 020866. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 020866

New drug application identity from the Orange Book snapshot.

Application holder
Veroscience LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
13

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 0.8MG BASETABLETORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Veroscience LLC

The Orange Book identifies this organization as the applicant responsible for NDA 020866.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

13 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 30, 2032. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

6 other ANDAs and 1 other NDA found

4 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 020866 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-020866

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 020866
RLDRS
Strength
EQ 0.8MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity
  1. Approval

    FDA approval date of this drug product.

    17 yr 6 mo ago

  2. Today

  3. Patent 10688155 expires

    Listed method-of-use patent (U-2898) expiration.

    in 3 yr 11 mo

  4. Patent 10688155 expires

    Listed method-of-use patent (U-2905) expiration.

    in 3 yr 11 mo

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    in 3 yr 11 mo

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    in 3 yr 11 mo

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  11. Patent 10688155 expires

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  52. Patent 8877708 expires

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    in 5 yr 10 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 10688155Patent 10688155: 2030-06-07Patent 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2032-04-30Patent 11666567Patent 8431155: 2032-04-30Patent 8431155Patent 8613947: 2032-04-30Patent 8613947Patent 9192576: 2032-04-30Patent 9192576Patent 9522117: 2032-04-30Patent 9522117Patent 9522117: 2032-04-30Patent 9522117Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9700555: 2032-04-30Patent 9700555Patent 9993474: 2032-04-30Patent 9993474Patent 9993474: 2032-04-30Patent 9993474Patent 9993474: 2032-04-30Patent 9993474Patent 9993474: 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Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BROMOCRIPTINE MESYLATE

Strength

EQ 0.8MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020866

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10688155in 3 yr 11 mo
U-2898
10688155in 3 yr 11 mo
U-2905
10688155in 3 yr 11 mo
U-2902
10688155in 3 yr 11 mo
U-2890
10688155in 3 yr 11 mo
U-2914
10688155in 3 yr 11 mo
U-2911
10688155in 3 yr 11 mo
U-2903
10688155in 3 yr 11 mo
U-2281
10688155in 3 yr 11 mo
U-2901
10688155in 3 yr 11 mo
U-2912
10688155in 3 yr 11 mo
U-2891
10688155in 3 yr 11 mo
U-2896
10688155in 3 yr 11 mo
U-2893
10688155in 3 yr 11 mo
U-2899
10688155in 3 yr 11 mo
U-2904
10688155in 3 yr 11 mo
U-2900
10688155in 3 yr 11 mo
U-2906
10688155in 3 yr 11 mo
U-2908
10688155in 3 yr 11 mo
U-2913
10688155in 3 yr 11 mo
U-2894
10688155in 3 yr 11 mo
U-2910
10688155in 3 yr 11 mo
U-2892
10688155in 3 yr 11 mo
U-2895
10688155in 3 yr 11 mo
U-2909
10688155in 3 yr 11 mo
U-2897
10688155in 3 yr 11 mo
U-2907
10688155in 3 yr 11 mo
U-2936
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ProductU-1706
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U-2389

Active-ingredient family

Brand + generics

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Cycloset: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 020866 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

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