Details for New Drug Application (NDA): 208090
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | 208090-001 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-002 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-002 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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