TAPENTADOL HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for tapentadol hydrochloride and what is the scope of freedom to operate?
Tapentadol hydrochloride
is the generic ingredient in two branded drugs marketed by Collegium Pharm Inc and is included in three NDAs. There are four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tapentadol hydrochloride has two hundred and seventy-two patent family members in thirty-one countries.
There are four drug master file entries for tapentadol hydrochloride. One supplier is listed for this compound. There are three tentative approvals for this compound.
Summary for TAPENTADOL HYDROCHLORIDE
| International Patents: | 272 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 67 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAPENTADOL HYDROCHLORIDE |
| What excipients (inactive ingredients) are in TAPENTADOL HYDROCHLORIDE? | TAPENTADOL HYDROCHLORIDE excipients list |
| DailyMed Link: | TAPENTADOL HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAPENTADOL HYDROCHLORIDE
Generic Entry Dates for TAPENTADOL HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SOLUTION;ORAL |
Generic Entry Dates for TAPENTADOL HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
Generic Entry Dates for TAPENTADOL HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TAPENTADOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aretaieion University Hospital | N/A |
| All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
| Oslo University Hospital | Phase 4 |
Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 20MG BASE/ML | SOLUTION;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 100MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 75MG | 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 TAPENTADOL HYDROCHLORIDE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Paragraph IV (Patent) Challenges for TAPENTADOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUCYNTA | Oral Solution | tapentadol hydrochloride | 20 mg/mL | 203794 | 1 | 2013-12-20 |
| NUCYNTA | Tablets | tapentadol hydrochloride | 50 mg, 75 mg, and 100 mg | 022304 | 4 | 2012-11-20 |
| NUCYNTA ER | Extended-release Tablets | tapentadol hydrochloride | 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg | 200533 | 2 | 2012-11-20 |
US Patents and Regulatory Information for TAPENTADOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 TAPENTADOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TAPENTADOL HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5202963 | ⤷ Try a Trial | |
| Poland | 1765298 | ⤷ Try a Trial | |
| Japan | 2018030886 | ニューロパシー痛の治療のための１−フェニル−３−ジメチルアミノ−プロパン化合物の使用 (USE OF 1-PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR TREATING NEUROPATHIC PAIN) | ⤷ Try a Trial |
| Slovenia | 1845956 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAPENTADOL HYDROCHLORIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | SPC/GB11/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204 |
| 0693475 | PA2011007 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819 |
| 0693475 | C300541 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819 |
| 1439829 | C 2011 002 | Romania | ⤷ Try a Trial | PRODUCT NAME: TAPENTADOL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO 3279/2011/01 - RO 3279/2011/22; DATE OF NATIONAL AUTHORISATION: 20110228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE 75.046; DATE OF FIRST AUTHORISATION IN EEA: 20100819 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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