OLEPTRO Drug Patent Profile
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Which patents cover Oleptro, and when can generic versions of Oleptro launch?
Oleptro is a drug marketed by Angelini Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-eight patent family members in thirty countries.
The generic ingredient in OLEPTRO is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Oleptro
A generic version of OLEPTRO was approved as trazodone hydrochloride by APOTEX on March 25th, 1987.
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Summary for OLEPTRO
| International Patents: | 78 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 8 |
| Patent Applications: | 1,664 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OLEPTRO |
| DailyMed Link: | OLEPTRO at DailyMed |
Recent Clinical Trials for OLEPTRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Louis Stokes VA Medical Center | Phase 1 |
| VA Connecticut Healthcare System | Phase 4 |
| Labopharm Inc. | Phase 1 |
Paragraph IV (Patent) Challenges for OLEPTRO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OLEPTRO | Extended-release Tablets | trazodone hydrochloride | 150 mg and 300 mg | 022411 | 1 | 2010-10-18 |
US Patents and Regulatory Information for OLEPTRO
OLEPTRO is protected by two US patents.
Patents protecting OLEPTRO
Trazodone composition for once a day administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DEPRESSION
Trazodone and trazodone hydrochloride in purified form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-001 | Feb 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-002 | Feb 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-001 | Feb 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-002 | Feb 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 OLEPTRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-001 | Feb 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Angelini Pharma | OLEPTRO | trazodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411-002 | Feb 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OLEPTRO
See the table below for patents covering OLEPTRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | MI20071603 | TRAZODONE E TRAZODONE CLORIDRATO IN FORMA PURIFICATA | ⤷ Sign Up |
| Hong Kong | 1139405 | 純化形式的曲唑酮和鹽酸曲唑酮 (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM) | ⤷ Sign Up |
| Eurasian Patent Organization | 201070228 | ТРАЗОДОН И ГИДРОХЛОРИД ТРАЗОДОНА В ОЧИЩЕННОЙ ФОРМЕ | ⤷ Sign Up |
| Japan | 2010535170 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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