FDA application holder
Veroscience LLC
The Orange Book identifies this organization as the applicant responsible for NDA 020866.
Bromocriptine Mesylate
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.
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | EQ 0.8MG BASE | TABLETORAL | Prescription | None posted | RLDRS |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
FDA application holder
The Orange Book identifies this organization as the applicant responsible for NDA 020866.
Manufacturer status
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.
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.
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.
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.
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.
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.
Bromocriptine Mesylate
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.
Approval
FDA approval date of this drug product.
17 yr 6 mo ago
Today
Patent 10688155 expires
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Patent 10688155 expires
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Patent 8877708 expires
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Patent 9352025 expires
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Patent 10688094 expires
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Patent 11000522 expires
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Patent 11000522 expires
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Patent 11666567 expires
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Patent 11666567 expires
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Patent 11666567 expires
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Patent 8431155 expires
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Patent 8613947 expires
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Patent 9192576 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9700555 expires
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Patent 9993474 expires
Listed method-of-use patent (U-2393) expiration.
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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Patent 9993474 expires
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in 5 yr 10 mo
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
| Patent | Expires | In | Type |
|---|---|---|---|
| 10688155 | in 3 yr 11 mo | U-2898 | |
| 10688155 | in 3 yr 11 mo | U-2905 | |
| 10688155 | in 3 yr 11 mo | U-2902 | |
| 10688155 | in 3 yr 11 mo | U-2890 | |
| 10688155 | in 3 yr 11 mo | U-2914 | |
| 10688155 | in 3 yr 11 mo | U-2911 | |
| 10688155 | in 3 yr 11 mo | U-2903 | |
| 10688155 | in 3 yr 11 mo | U-2281 | |
| 10688155 | in 3 yr 11 mo | U-2901 | |
| 10688155 | in 3 yr 11 mo | U-2912 | |
| 10688155 | in 3 yr 11 mo | U-2891 | |
| 10688155 | in 3 yr 11 mo | U-2896 | |
| 10688155 | in 3 yr 11 mo | U-2893 | |
| 10688155 | in 3 yr 11 mo | U-2899 | |
| 10688155 | in 3 yr 11 mo | U-2904 | |
| 10688155 | in 3 yr 11 mo | U-2900 | |
| 10688155 | in 3 yr 11 mo | U-2906 | |
| 10688155 | in 3 yr 11 mo | U-2908 | |
| 10688155 | in 3 yr 11 mo | U-2913 | |
| 10688155 | in 3 yr 11 mo | U-2894 | |
| 10688155 | in 3 yr 11 mo | U-2910 | |
| 10688155 | in 3 yr 11 mo | U-2892 | |
| 10688155 | in 3 yr 11 mo | U-2895 | |
| 10688155 | in 3 yr 11 mo | U-2909 | |
| 10688155 | in 3 yr 11 mo | U-2897 | |
| 10688155 | in 3 yr 11 mo | U-2907 | |
| 10688155 | in 3 yr 11 mo | U-2936 | |
| 10688155 | in 3 yr 11 mo | U-2915 | |
| 10688155 | in 3 yr 11 mo | U-2935 | |
| 10688155 | in 3 yr 11 mo | U-2932 | |
| 10688155 | in 3 yr 11 mo | U-2924 | |
| 10688155 | in 3 yr 11 mo | U-2926 | |
| 10688155 | in 3 yr 11 mo | U-2931 | |
| 10688155 | in 3 yr 11 mo | U-2927 | |
| 10688155 | in 3 yr 11 mo | U-2918 | |
| 10688155 | in 3 yr 11 mo | U-2933 | |
| 10688155 | in 3 yr 11 mo | U-2916 | |
| 10688155 | in 3 yr 11 mo | U-2920 | |
| 10688155 | in 3 yr 11 mo | U-2922 | |
| 10688155 | in 3 yr 11 mo | U-2921 | |
| 10688155 | in 3 yr 11 mo | U-2919 | |
| 10688155 | in 3 yr 11 mo | U-2930 | |
| 10688155 | in 3 yr 11 mo | U-2917 | |
| 10688155 | in 3 yr 11 mo | U-2925 | |
| 10688155 | in 3 yr 11 mo | U-2929 | |
| 10688155 | in 3 yr 11 mo | U-2923 | |
| 10688155 | in 3 yr 11 mo | U-2937 | |
| 10688155 | in 3 yr 11 mo | U-2928 | |
| 10688155 | in 3 yr 11 mo | U-2934 | |
| 8877708 | in 3 yr 11 mo | ProductU-1706 | |
| 9352025 | in 3 yr 11 mo | U-2111 | |
| 9352025 | in 3 yr 11 mo | U-2113 | |
| 9352025 | in 3 yr 11 mo | U-2117 | |
| 9352025 | in 3 yr 11 mo | U-2114 | |
| 9352025 | in 3 yr 11 mo | U-2118 | |
| 9352025 | in 3 yr 11 mo | U-2115 | |
| 9352025 | in 3 yr 11 mo | U-2112 | |
| 9352025 | in 3 yr 11 mo | U-2119 | |
| 9352025 | in 3 yr 11 mo | U-2116 | |
| 9895422 | in 3 yr 11 mo | U-2285 | |
| 9895422 | in 3 yr 11 mo | U-2282 | |
| 9895422 | in 3 yr 11 mo | U-2287 | |
| 9895422 | in 3 yr 11 mo | U-2116 | |
| 9895422 | in 3 yr 11 mo | U-2114 | |
| 9895422 | in 3 yr 11 mo | U-2284 | |
| 9895422 | in 3 yr 11 mo | U-2286 | |
| 9895422 | in 3 yr 11 mo | U-2281 | |
| 9895422 | in 3 yr 11 mo | U-2283 | |
| 10688094 | in 5 yr 10 mo | U-2871 | |
| 10688094 | in 5 yr 10 mo | U-2872 | |
| 10688094 | in 5 yr 10 mo | U-2875 | |
| 10688094 | in 5 yr 10 mo | U-2870 | |
| 10688094 | in 5 yr 10 mo | U-2873 | |
| 10688094 | in 5 yr 10 mo | U-2874 | |
| 10688094 | in 5 yr 10 mo | U-2876 | |
| 10688094 | in 5 yr 10 mo | U-2881 | |
| 10688094 | in 5 yr 10 mo | U-2878 | |
| 10688094 | in 5 yr 10 mo | U-2877 | |
| 10688094 | in 5 yr 10 mo | U-2880 | |
| 10688094 | in 5 yr 10 mo | U-2879 | |
| 10688094 | in 5 yr 10 mo | U-2887 | |
| 10688094 | in 5 yr 10 mo | U-2885 | |
| 10688094 | in 5 yr 10 mo | U-2884 | |
| 10688094 | in 5 yr 10 mo | U-2882 | |
| 10688094 | in 5 yr 10 mo | U-2883 | |
| 10688094 | in 5 yr 10 mo | U-2888 | |
| 10688094 | in 5 yr 10 mo | U-2886 | |
| 11000522 | in 5 yr 10 mo | U-3119 | |
| 11000522 | in 5 yr 10 mo | U-3121 | |
| 11000522 | in 5 yr 10 mo | U-3120 | |
| 11000522 | in 5 yr 10 mo | U-3122 | |
| 11666567 | in 5 yr 10 mo | U-4015 | |
| 11666567 | in 5 yr 10 mo | U-4016 | |
| 11666567 | in 5 yr 10 mo | U-4017 | |
| 11666567 | in 5 yr 10 mo | U-4018 | |
| 8431155 | in 5 yr 10 mo | ProductU-976 | |
| 8613947 | in 5 yr 10 mo | ProductU-976 | |
| 9192576 | in 5 yr 10 mo | ProductU-976 | |
| 9522117 | in 5 yr 10 mo | ProductU-1939 | |
| 9522117 | in 5 yr 10 mo | ProductU-976 | |
| 9700555 | in 5 yr 10 mo | ProductU-2190 | |
| 9700555 | in 5 yr 10 mo | ProductU-2194 | |
| 9700555 | in 5 yr 10 mo | ProductU-2188 | |
| 9700555 | in 5 yr 10 mo | ProductU-2184 | |
| 9700555 | in 5 yr 10 mo | ProductU-2191 | |
| 9700555 | in 5 yr 10 mo | ProductU-2187 | |
| 9700555 | in 5 yr 10 mo | ProductU-2183 | |
| 9700555 | in 5 yr 10 mo | ProductU-2193 | |
| 9700555 | in 5 yr 10 mo | ProductU-2189 | |
| 9700555 | in 5 yr 10 mo | ProductU-2198 | |
| 9700555 | in 5 yr 10 mo | ProductU-2192 | |
| 9700555 | in 5 yr 10 mo | ProductU-2186 | |
| 9700555 | in 5 yr 10 mo | ProductU-2185 | |
| 9700555 | in 5 yr 10 mo | ProductU-2195 | |
| 9700555 | in 5 yr 10 mo | ProductU-2197 | |
| 9700555 | in 5 yr 10 mo | ProductU-2196 | |
| 9993474 | in 5 yr 10 mo | U-2393 | |
| 9993474 | in 5 yr 10 mo | U-2385 | |
| 9993474 | in 5 yr 10 mo | U-2391 | |
| 9993474 | in 5 yr 10 mo | U-2384 | |
| 9993474 | in 5 yr 10 mo | U-2390 | |
| 9993474 | in 5 yr 10 mo | U-2388 | |
| 9993474 | in 5 yr 10 mo | U-2386 | |
| 9993474 | in 5 yr 10 mo | U-2392 | |
| 9993474 | in 5 yr 10 mo | U-2387 | |
| 9993474 | in 5 yr 10 mo | U-2389 |
This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
NDA 017962 · Esjay Pharma
ANDA 077646 · Padagis US
ANDA 078899 · Zydus Pharms USA Inc
ANDA 077226 · Mylan
ANDA 076962 · Aurobindo Pharma USA
ANDA 075100 · Lek Pharm
ANDA 074631 · Sandoz
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.
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.
