ARMODAFINIL Drug Patent Profile
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When do Armodafinil patents expire, and what generic alternatives are available?
Armodafinil is a drug marketed by Aurobindo Pharma Ltd, Corepharma, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc. and is included in six NDAs.
The generic ingredient in ARMODAFINIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Armodafinil
A generic version of ARMODAFINIL was approved as armodafinil by MYLAN PHARMS INC on June 1st, 2012.
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Questions you can ask:
- What is the 5 year forecast for ARMODAFINIL?
- What are the global sales for ARMODAFINIL?
- What is Average Wholesale Price for ARMODAFINIL?
Summary for ARMODAFINIL
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 59 |
| Patent Applications: | 4,235 |
| Drug Prices: | Drug price information for ARMODAFINIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARMODAFINIL |
| What excipients (inactive ingredients) are in ARMODAFINIL? | ARMODAFINIL excipients list |
| DailyMed Link: | ARMODAFINIL at DailyMed |
Recent Clinical Trials for ARMODAFINIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Charles Andrew Czeisler, MD, PhD | Phase 4 |
| Jazz Pharmaceuticals | Phase 4 |
| University of Florida | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ARMODAFINIL
Paragraph IV (Patent) Challenges for ARMODAFINIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUVIGIL | Tablets | armodafinil | 100 mg | 021875 | 1 | 2009-09-08 |
| NUVIGIL | Tablets | armodafinil | 200 mg | 021875 | 1 | 2009-09-03 |
| NUVIGIL | Tablets | armodafinil | 50 mg, 150 mg and 250 mg | 021875 | 1 | 2009-07-24 |
US Patents and Regulatory Information for ARMODAFINIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 206069-001 | Mar 6, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Natco Pharma Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 202768-004 | Sep 28, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Corepharma | ARMODAFINIL | armodafinil | TABLET;ORAL | 201514-003 | Mar 25, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 206069-003 | Mar 6, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Pharms Inc | ARMODAFINIL | armodafinil | TABLET;ORAL | 200043-001 | Jun 1, 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 |
