PROVIGIL Drug Patent Profile
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When do Provigil patents expire, and what generic alternatives are available?
Provigil is a drug marketed by Cephalon and is included in one NDA. There is one patent protecting this drug.
This drug has sixty-two patent family members in twenty-eight countries.
The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the modafinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Provigil
A generic version of PROVIGIL was approved as modafinil by ORBION PHARMS on September 26th, 2012.
Summary for PROVIGIL
| International Patents: | 62 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 70 |
| Patent Applications: | 3,714 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROVIGIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROVIGIL |
| What excipients (inactive ingredients) are in PROVIGIL? | PROVIGIL excipients list |
| DailyMed Link: | PROVIGIL at DailyMed |
Recent Clinical Trials for PROVIGIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kuwait University | Early Phase 1 |
| The Ottawa Hospital | Phase 3 |
| Bruyere Research Institute | Phase 3 |
Pharmacology for PROVIGIL
| Drug Class | Sympathomimetic-like Agent |
| Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Anatomical Therapeutic Chemical (ATC) Classes for PROVIGIL
US Patents and Regulatory Information for PROVIGIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for PROVIGIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROVIGIL
See the table below for patents covering PROVIGIL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Iceland | 2707 | ⤷ Try a Trial | |
| Denmark | 152207 | ⤷ Try a Trial | |
| Ireland | 870240 | ⤷ Try a Trial | |
| Germany | 60328119 | ⤷ Try a Trial | |
| New Zealand | 530040 | Solid pharmaceutical formulations comprising modafinil | ⤷ Try a Trial |
| Denmark | 0966962 | ⤷ Try a Trial | |
| New Zealand | 538940 | Novel pharmaceutical formulations of modafinil | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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