Slynd generics — when can they launch?
Slynd (DROSPIRENONE) · Exeltis Usa Inc · 42 active US patents · 0 expired
Where Slynd sits in the generic timeline
Imminent generic cliff: earliest active US patent for Slynd expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Formulation — 22 patents
- Method of Use — 20 patents
FDA U-codes carved out by Slynd patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-3152 | (no description) |
U-1 | Treatment of a specific disease/condition (broad) |
U-2553 | (no description) |
Sample patent estate
Showing 6 of 42 active US patents. View full estate on the Slynd drug page →
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This patent protects a method of contraception that involves the oral administration of a specific type of estrogen and a progestogenic component to a female.USPTO title: Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
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This patent protects a solid oral contraceptive composition containing drospirenone, ethinylestradiol, and calcium 5-methyl-(6S)-tetrahydrofolate.USPTO title: Pharmaceutical composition containing a tetrahydrofolic acid
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This patent protects a solid oral contraceptive composition containing drospirenone, ethinylestradiol, and calcium 5-methyl-(6S)-tetrahydrofolate.USPTO title: Pharmaceutical composition containing a tetrahydrofolic acid
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This patent protects a pharmaceutical composition containing a tetrahydrofolic acid, used in oral contraceptives.USPTO title: Pharmaceutical composition containing a tetrahydrofolic acid
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This patent protects a pharmaceutical composition containing a tetrahydrofolic acid, used in oral contraceptives.USPTO title: Pharmaceutical composition containing a tetrahydrofolic acid
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This patent protects pharmaceutical compositions and methods for administering active contraceptive drugs, specifically progestogen-only contraceptives like Drosphirenone.USPTO title: Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Sources
- FDA Orange Book — patents listed against Slynd (NDA filed 2019)
- Slynd drug profile — full patent estate, indications, clinical trials, pricing
- Exeltis Usa Inc patent portfolio
- Patent cliff 2028 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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