Modafinil - Generic Drug Details
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What are the generic drug sources for modafinil and what is the scope of freedom to operate?
Modafinil
is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, Watson Labs Inc, and Cephalon, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Modafinil has sixty-two patent family members in twenty-eight countries.
There are twenty-six drug master file entries for modafinil. Twenty suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for modafinil
International Patents: | 62 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 10 |
NDAs: | 10 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 165 |
Patent Applications: | 6,756 |
Drug Prices: | Drug price trends for modafinil |
Drug Sales Revenues: | Drug sales revenues for modafinil |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for modafinil |
What excipients (inactive ingredients) are in modafinil? | modafinil excipients list |
DailyMed Link: | modafinil at DailyMed |
Recent Clinical Trials for modafinil
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kuwait University | Early Phase 1 |
Genuine Research Center, Egypt | Phase 1 |
Chemipharm Pharmaceutical Industries, Egypt | Phase 1 |
Generic filers with tentative approvals for MODAFINIL
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 100MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | Tablet; Oral |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for modafinil
Drug Class | Sympathomimetic-like Agent |
Physiological Effect | Central Nervous System Stimulation Increased Sympathetic Activity |
Anatomical Therapeutic Chemical (ATC) Classes for modafinil
US Patents and Regulatory Information for modafinil
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | MODAFINIL | modafinil | TABLET;ORAL | 077667-001 | Feb 3, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Natco Pharma | MODAFINIL | modafinil | TABLET;ORAL | 076594-002 | Jul 16, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 modafinil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-001 | Dec 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for modafinil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1318026 | ⤷ Sign Up | |
Poland | 375831 | ⤷ Sign Up | |
Spain | 2325860 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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