When do drug patents expire and when can generic drugs launch?

WHEN DO DRUG PATENTS EXPIRE?DrugPatentWatch.com

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Contents• Slide 3: Patents and Drug Development• Slide 4: Patent Claim Types• Slide 8: Patent Extension• Slide 9: Non-Patent Protection• Slide 12: Patent and Regulatory Exclusivity Timeline• Slide 15: Summary: When can Generics Launch?


Types of Patent ClaimsThe ‘claims’ define what a patent protects

Product patents • Cover the active ingredient or compound in a drug

Process patents • Cover a process for manufacturing a drug

Method-of-use patents• Protect a particular method of using a drug (e.g. specific diseases)

Formulation patents • Cover active and inactive ingredients in a drug (e.g. final dosage form, tablet, or

capsule)


Patent Claims and Generic EntryProduct claims• Generally impossible to work around. Patents containing these claims must all

expire or be invalidated

Process claims• It may be possible to develop alternative production methods

Method-of-use claims• A generic may gain approval for unpatented uses, and hope that physicians will

prescribe the drug off-label for the patented uses

Formulation claims• Generics may be able to work around some formulation patents


DrugPatentWatch Shows Patent Claim Types


DrugPatentWatch Also Shows Patent Claims


When do Drug Patents Expire

Short Answer: 20 years from the date of filing

But it is much, much, more complicated…


Patent Extensions and Regulatory Exclusivities

Enable recovery of time spent waiting for regulatory approval

US: Hatch-Waxman Patent Extensions• Listed as patent expiration date by DrugPatentWatch

EU: Supplementary Protection Certificates• Ex-US patent information shows estimated expiration date. SPC expiry listed

separately.


Non-Patent Regulatory ExclusivitiesNew Chemical Entity: 5 years• A compound never before approved for any indication

New Clinical Investigation: 3 years• A new formulation, new patient population, new dosage regimen, etc.

Orphan Drug: 7 years• Treatments for rare diseases

Conduct Pediatric Clinical Trials Following FDA Request: 6 months

First Successful Patent Challenge: 6 months generic exclusivity


DrugPatentWatch has US Regulatory Exclusivity and EU SPCs


DrugPatentWatch Lists Exclusivity Expirations


Drug Patents are Generally Filed Years Before Approval

Patent (20 years + extensions)

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Most Regulatory Exclusivities Start From Drug Approval

5 years


3 years New Clinical Investigation

New Chemical Entity

7 years Orphan Drug ExclusivityDr

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Pediatric Exclusivity and SPCs (EU) Start When Patents Expire

5 years


3 years New Clinical Investigation

New Chemical Entity

Pediatric Exclusivity / SPC

7 years Orphan Drug ExclusivityDr

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Summary: When Can Generics Launch?

All ‘blocking’ patents must be expired (or invalidated)• Composition of matter, core formulation, etc.• Some method of use or enhanced formulation patents may

not fully block generics.

All regulatory exclusivities must be expired• NCE, pediatric exclusivity, etc.

When do drug patents expire and when can generic drugs launch?

Health & Medicine

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