Details for New Drug Application (NDA): 208090
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NDA 208090 describes XTAMPZA ER, which is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTAMPZA ER profile page.
The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.
The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.
Summary for 208090
| Tradename: | XTAMPZA ER |
| Applicant: | Collegium Pharm Inc |
| Ingredient: | oxycodone |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208090
Generic Entry Date for 208090*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;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.
Pharmacology for NDA: 208090
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 208090
Suppliers and Packaging for NDA: 208090
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090 | NDA | Collegium Pharmaceutical, Inc. | 24510-110 | 24510-110-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-110-10) |
| XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090 | NDA | Collegium Pharmaceutical, Inc. | 24510-110 | 24510-110-20 | 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-110-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 9MG | ||||
| Approval Date: | Apr 26, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 10, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 2, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 2, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
Expired US Patents for NDA 208090
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-004 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-004 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-004 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-001 | Apr 26, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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