MODAFINIL Drug Patent Profile
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Which patents cover Modafinil, and when can generic versions of Modafinil launch?
Modafinil is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, and Watson Labs Inc. and is included in nine NDAs.
The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the modafinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Modafinil
A generic version of MODAFINIL was approved as modafinil by ORBION PHARMS on September 26th, 2012.
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Questions you can ask:
- What is the 5 year forecast for MODAFINIL?
- What are the global sales for MODAFINIL?
- What is Average Wholesale Price for MODAFINIL?
Summary for MODAFINIL
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 165 |
| Patent Applications: | 5,014 |
| Drug Prices: | Drug price information 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 |
| Chemipharm Pharmaceutical Industries, Egypt | Phase 1 |
| Genuine Research Center, Egypt | Phase 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | MODAFINIL | modafinil | TABLET;ORAL | 202700-001 | Oct 18, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs Inc | MODAFINIL | modafinil | TABLET;ORAL | 076715-002 | Nov 1, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | MODAFINIL | modafinil | TABLET;ORAL | 202566-001 | Sep 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | MODAFINIL | modafinil | TABLET;ORAL | 077667-002 | Feb 3, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Pharms | MODAFINIL | modafinil | TABLET;ORAL | 090543-002 | Sep 26, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | MODAFINIL | modafinil | TABLET;ORAL | 202566-002 | Sep 27, 2012 | AB | RX | 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 |
