PRAMIPEXOLE DIHYDROCHLORIDE Drug Patent Profile
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When do Pramipexole Dihydrochloride patents expire, and what generic alternatives are available?
Pramipexole Dihydrochloride is a drug marketed by Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc. and is included in thirty NDAs.
The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pramipexole Dihydrochloride
A generic version of PRAMIPEXOLE DIHYDROCHLORIDE was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.
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Questions you can ask:
- What is the 5 year forecast for PRAMIPEXOLE DIHYDROCHLORIDE?
- What are the global sales for PRAMIPEXOLE DIHYDROCHLORIDE?
- What is Average Wholesale Price for PRAMIPEXOLE DIHYDROCHLORIDE?
Summary for PRAMIPEXOLE DIHYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 30 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 98 |
| Clinical Trials: | 121 |
| Patent Applications: | 1,958 |
| Drug Prices: | Drug price information for PRAMIPEXOLE DIHYDROCHLORIDE |
| DailyMed Link: | PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Region Skane | Phase 3 |
| Lund University | Phase 3 |
| Hoffmann-La Roche | Phase 1 |
Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PRAMIPEXOLE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MIRAPEX ER | Extended-release Tablets | pramipexole dihydrochloride | 2.25 mg and 3.75 mg | 022421 | 1 | 2011-07-26 |
| MIRAPEX ER | Extended-release Tablets | pramipexole dihydrochloride | 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg | 022421 | 1 | 2010-06-01 |
| MIRAPEX | Tablets | pramipexole dihydrochloride | 0.75 mg | 020667 | 1 | 2008-07-31 |
| MIRAPEX | Tablets | pramipexole dihydrochloride | 0.125 mg, 0.5 mg, 1 mg and 1.5 mg | 020667 | 1 | 2005-06-24 |
| MIRAPEX | Tablets | pramipexole dihydrochloride | 0.25 mg | 020667 | 1 | 2005-05-27 |
US Patents and Regulatory Information for PRAMIPEXOLE DIHYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms Ltd | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 090781-001 | Oct 8, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Natco | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 077854-003 | Oct 8, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202353-001 | Dec 4, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 206156-007 | Jan 23, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms Usa Inc | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 078920-002 | Jul 6, 2010 | 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 |
