Lynparza generics — when can they launch?
Lynparza (olaparib) · AstraZeneca · 25 active US patents · 0 expired
Where Lynparza sits in the generic timeline
Imminent generic cliff: earliest active US patent for Lynparza expires in 2027 (~1 year 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 — 12 patents
- Method of Use — 10 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Lynparza 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-3631 | (no description) |
U-2482 | (no description) |
U-1634 | (no description) |
U-2480 | (no description) |
U-2101 | (no description) |
U-3929 | (no description) |
Sample patent estate
Showing 6 of 25 active US patents. View full estate on the Lynparza drug page →
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This patent protects methods for treating cancers that are deficient in a specific type of DNA repair using inhibitors that target the base excision repair pathway.USPTO title: DNA damage repair inhibitors for the treatment of cancer
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This patent protects methods for treating cancers that are deficient in a specific type of DNA repair using inhibitors that target the base excision repair pathway.USPTO title: DNA damage repair inhibitors for treatment of cancer
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This patent protects methods for treating cancers that are deficient in a specific type of DNA repair using inhibitors that target the base excision repair pathway.USPTO title: DNA damage repair inhibitors for treatment of cancer
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This patent protects methods for treating cancers that are deficient in a specific type of DNA repair using inhibitors that target the base excision repair pathway.USPTO title: DNA damage repair inhibitors for treatment of cancer
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This patent protects methods for treating cancers that are deficient in a specific type of DNA repair using inhibitors that target the base excision repair pathway.USPTO title: DNA damage repair inhibitors for the treatment of cancer
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This patent protects novel phthalazinone derivatives, specifically compounds of the formula (I), which are fused aromatic ring systems with various substituents.USPTO title: Phthalazinone derivatives
Sources
- FDA Orange Book — patents listed against Lynparza (NDA filed 2014)
- Lynparza drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca patent portfolio
- Patent cliff 2027 — 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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